Esophageal CancerPhase 3MRD2STARTNCT06914011

Circulating Tumor DNA MRD-Guided Adjuvant Therapy for Curatively Resected Locally Advanced Esophageal Squamous Cell Carcinoma

A Phase 3 study testing Tislelizumab in people with Esophageal Cancer, run by Asan Medical Center.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Trial summary

This study was a multicenter, randomized, phase 3 trial to determine whether adjuvant chemotherapy including tisleliizumab improves recurrence-free survival compared to follow-up alone without chemotherapy in patients with curatively resected esophageal squamous cell carcinoma. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Esophageal Cancer
What is being tested?: Tislelizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 172 participants
Where: No sites listed yet
Study dates: 31 Dec 2026to 30 May 2034
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Be willing and able to provide written informed consent. 2. Be ≥19 years of age on the day of signing the informed consent form. 3. Have ECOG performance status of 0 or 1 (Appendix 1). 4. Have a histologically confirmed diagnosis of squamous cell carcinoma of the esophagus
Patients with tumors of mixed histology (i.e., squamous and non-squamous) are eligible if the predominant histological component is squamous, except when small cell or neuroendocrine elements are present.
5. Must have completed surgical resection for localized disease, either with prior neoadjuvant therapy (chemotherapy or chemoradiotherapy) or without prior neoadjuvant therapy (i.e., upfront surgery), in accordance with the 8th edition of the AJCC staging system (Appendix 2). Exceptionally, cases with supraclavicular lymph node metastasis as the only M1 lesion are also eligible if the lymph node has been surgically removed.
6. Must have undergone curative surgery (R0 resection) with negative margins on the resected specimen.
7. Complete resection must have been performed between 4-16 weeks before randomization.
8. Must have a documented disease-free status based on a complete physical examination and imaging studies within 4 weeks before randomization. Imaging studies must include CT scans (or MRI) of the chest, abdomen, and pelvis.

Show all 24Show fewer

9. Must provide tumor tissue from pre-treatment biopsy (i.e., a biopsy obtained prior to neoadjuvant therapy in cases where neoadjuvant therapy is followed by surgery) or from surgical specimens and baseline blood samples for post-surgery ctDNA-MRD measurement and biomarker analyses.
For patients who underwent upfront surgery, surgical tissue is preferred.
For those who received neoadjuvant therapy followed by surgery, pre-treatment biopsy tissue is required. If pre-treatment biopsy tissue is unavailable or inadequate, submission of surgical specimens may be permitted following approval by the Study Sponsor.
A FFPE tumor specimen in a paraffin block or 20 (at least 10, with a thickness of 10 µm) freshly cut unstained FFPE slides, along with one H\&E-stained slide, must be submitted with the associated pathology report. If an insufficient number of slides is available, the decision on patient enrollment can be made in consultation with the Study Sponsor.
Peripheral blood of approximately 4 mL must be collected for germline DNA analysis.
Peripheral blood of approximately 20 mL must be collected between 3 to 12 weeks after curative surgery for ctDNA testing.
10. Must be confirmed to have MRD-positive status via postoperative baseline ctDNA testing.
11. Must have adequate major organ functions as demonstrated by the following laboratory results obtained within 14 days before randomization (these criteria must also be met within 7 days before initiating study treatment in the adjuvant therapy arm):
Adequate bone marrow function defined by:
Absolute neutrophil count (ANC) ≥ 1,500/μL without granulocyte colony-stimulating factor support within 7 days before laboratory testing
Platelet count ≥ 100 ×103/μL without transfusion within 7 days before laboratory testing
Adequate renal function defined by:
Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (CrCl) ≥ 50 mL/minute, calculated using the Cockcroft-Gault formula (Appendix 3) or measured by a 24-hour urine collection
Adequate hepatic function defined by:
ALT and AST ≤ 2.5 × ULN
Total bilirubin ≤ 1.5 × ULN, except for subjects with Gilbert syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who must have a total bilirubin level ≤ 3 × ULN 12. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 14 days prior to randomization. If the urine test is positive or inconclusive, a serum pregnancy test will be required.
13. Female subjects of childbearing potential randomized to the adjuvant therapy arm must agree to use an adequate method of contraception for the duration of study treatment and for 90 days after the last dose of study treatment.
14. Non-sterile male subjects randomized to the adjuvant therapy arm with female sexual partner(s) of childbearing potential must agree to use an adequate method of contraception for the duration of study treatment and for 90 days after the last dose of study treatment.

Who cannot join

1. Documented recurrence of esophageal cancer before randomization following curative resection.
2. Receipt of any treatment aimed at the resected esophageal cancer after curative surgery, including chemotherapy, targeted therapy, immunotherapy, radiotherapy, biologic therapy, investigational agent, or local therapies, except for procedures intended for palliative care (e.g., stent insertion, balloon dilatation, or feeding enterostomy).
3. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) inhibitor, or any other drug targeting T-cell co-stimulation or checkpoint pathways.
4. Active autoimmune disease requiring systemic treatment within the 2 years prior to study entry (i.e., using disease-modifying agents, corticosteroids, or immunosuppressive drugs).
Replacement therapy (e.g., thyroxine for autoimmune-related hypothyroidism, insulin for type 1 diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
5. Condition requiring systemic treatment with corticosteroids (>10 mg daily prednisone or equivalent) or any other form of immunosuppressive therapy within 14 days prior to study entry.

Show all 25Show fewer

Use of topical, ocular, intra-articular, intranasal, and inhaled corticosteroids is permitted if there is no active autoimmune disease.
A short course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergens) is permitted.
6. Receipt of a live vaccine within 28 days prior to study entry.
COVID-19 vaccines are allowed except for any live vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
7. Active infection requiring systemic therapy within 14 days prior to study entry.
8. History of severe hypersensitivity to paclitaxel, carboplatin, or any antibody products.
9. Known history of, or any evidence of, interstitial lung disease, non-infectious pneumonitis, or pulmonary fibrosis diagnosed based on imaging or clinical findings.
Subjects with radiation pneumonitis may be enrolled if radiation pneumonitis is stable (beyond the acute phase) and unlikely to recur.
10. History of allogeneic stem cell or solid organ transplantation. 11. Malignancies other than esophageal cancer within the 3 years prior to study entry, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate >90%), such as adequately treated non-melanoma skin cancer, superficial bladder cancer, or carcinoma in situ (e.g., cervix, breast, or prostate).
Subjects who received endoscopic mucosal resection or dissection for superficial mucosal cancers within the past 3 years are eligible.
12. Subjects with toxicities attributed to prior anti-cancer therapy, except alopecia, anorexia, fatigue, and hearing loss, that have not resolved to Grade 1 (NCI CTCAE v5.0) or baseline before randomization will be excluded.
13. Significant cardiovascular impairment within 6 months prior to study entry, including a history of congestive heart failure (New York Heart Association Class III or IV), unstable angina, myocardial infarction, cerebrovascular accident, or cardiac arrhythmia associated with hemodynamic instability.
14. Any serious or uncontrolled medical disorder that, in the investigator's opinion, may increase the risk associated with study participation or study treatment administration, or compromise the subject's ability to receive protocol therapy.
15. History or current evidence of any condition, therapy, or laboratory abnormality that could confound trial results, interfere with the subject's participation for the full trial duration, or is not in the best interest of the subject to participate, in the investigator's opinion.
16. Medical or psychiatric conditions that impair the subject's ability to give informed consent or complete the protocol, or a history of non-compliance.
17. Known history of Human Immunodeficiency Virus (HIV) infection. 18. Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA ≥500 IU/mL (or 2,500 copies/mL), or active hepatitis C virus (HCV) infection:
Subjects with chronic hepatitis B (HBV DNA < 500 IU/mL or < 2,500 copies/mL) who are receiving antiviral therapy can be enrolled. Patients with detectable HBsAg or detectable HBV DNA should be managed according to institutional guidelines.
Patients with a negative HCV antibody test result at screening or a positive HCV antibody test followed by a negative HCV RNA test result at screening are eligible.
19. Pregnant or breastfeeding women 20. Any condition requiring treatment with prohibited or restricted concomitant medication or therapy as described in Section 6.2.2

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Sook Ryun Park, MD, Ph.D contact

82-2-3010-3206

srpark@amc.seoul.kr

About this study

Official title: Multi-center, Randomized, Phase III Trial of Circulating Tumor DNA MRD-Guided Adjuvant Therapy for Curatively Resected Locally Advanced Esophageal Squamous Cell Carcinoma (MRD2START)

Read the detailed description

It aims to investigate the efficacy of adjuvant therapy in patients at high risk, as determined by the presence of MRD through ctDNA testing, following curative R0 resection for locally advanced esophageal squamous cell carcinoma.

Patients found to be MRD-positive will be randomly allocated in a 2:1 ratio to either an adjuvant therapy arm or a surveillance arm.

Randomization will be stratified based on the administration of pre-surgery neoadjuvant therapy (yes vs. no), the pathological stage after surgery (0-2 vs. 3-4), and institution.

For participants assigned to the adjuvant therapy arm, those who underwent neoadjuvant chemoradiotherapy followed by surgery will receive adjuvant chemoimmunotherapy comprising paclitaxel + carboplatin + tislelizumab administered every 3 weeks for 4 cycles (Cycles 1-4), followed by tislelizumab monotherapy every 6 weeks for 6 cycles (Cycles 5-10). For patients who underwent neoadjuvant chemotherapy followed by surgery, or upfront surgery without prior neoadjuvant therapy, the choice between Option 1 (adjuvant chemoradioimmunotherapy) and Option 2 (adjuvant chemoimmunotherapy) will be made at the investigator's discretion. Adjuvant chemoradioimmunotherapy will consist of paclitaxel + carboplatin + tislelizumab every 3 weeks for one cycle (Cycle 1), then concurrent radiotherapy (45 Gy in 25 fractions, 1.8 Gy/fraction) with paclitaxel + carboplatin + tislelizumab (Cycle 2), followed by an additional cycle of paclitaxel + carboplatin + tislelizumab every three weeks (Cycle 3), and concluding with tislelizumab monotherapy every 6 weeks for 6 cycles (Cycles 4-9).

MRD-negative patients are excluded from the phase 3 trial. Instead, they will receive routine clinical care and are monitored as part of a separate observational study.

Conditions: Esophageal Cancer
Being tested: Tislelizumab
Medical subject headings: Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TislelizumabDrug
Also called Paclitaxel, Carboplatin
1. Option 1: adjuvant chemoradioimmunotherapy in the following sequence:
- Cycle 1: Tislelizumab 200 mg iv D1, Paclitaxel 175 mg/m2 iv D1, and Carboplatin AUC 5 mg/mL/min iv D1, in a 3-week cycle for one cycle
- Cycle 2: Concurrent radiotherapy (25 fractions of 1.8 Gy each, with 5 fractions per week) with Tislelizumab 200 mg iv D1, D22, Paclitaxel 50 mg/m2 iv D1, 8, 15, 22, 29, and Carboplatin AUC 2 mg/mL/min D1, 8, 15, 22, 29
- Cycle 3: Tislelizumab 200 mg iv D1, Paclitaxel 175 mg/m2 iv D1, and Carboplatin AUC 5 mg/mL/min iv D1, in a 3-week cycle for 1 cycle
- Cycles 4-9: Tislelizumab 400 mg iv D1, in a 6-week cycle for six cycles
1. Option 2: adjuvant chemoimmunotherapy in the following sequence:
- Cycles 1-4: Tislelizumab 200 mg iv D1, Paclitaxel 175 mg/m2 iv D1, and Carboplatin AUC 5 mg/mL/min iv D1, in a 3-week cycle for four cycles
- Cycles 5-10: Tislelizumab 400 mg iv D1, in a 6-week cycle for six cycles

Study groups in NCT06914011
Study group	Role	What they receive
Adjuvant therapy arm	Experimental	For participants assigned the adjuvant therapy arm, those who underwent neoadjuvant chemoradiotherapy followed by surgery will receive adjuvant chemoimmunotherapy. For patients who underwent neoadjuvant chemotherapy followed by surgery, or upfront surgery without prior neoadjuvant therapy, the choice between Option 1 (adjuvant chemoradioimmunotherapy) and Option 2 (adjuvant chemoimmunotherapy) will be made at the investigator's discretion. Adjuvant chemoradioimmunotherapy. Receives: Drug: Tislelizumab
Surveillance arm	No intervention	Surveillance arm will be followed up without any adjuvant therapy, undergoing CT scans every 12 weeks during the first 2 years after randomization, and thereafter every 24 weeks until 5 years after randomization

What is being measured

The primary outcome is the main question the study is designed to answer.

Recurrence-free survival as assessed by the investigator
Every 12weeks during the first two years after randomization then every 24weeks
Measured: For 5 years after randomization

Secondary outcomes (10)

Overall survival
Every 12weeks during the first two years after randomization then every 24weeks
Measured: For 5 years after randomization
Distant metastasis-free survival
Every 12weeks during the first two years after randomization then every 24weeks
Measured: For 5 years after randomization
Locoregional Recurrence-free survival
Every 12weeks during the first two years after randomization then every 24weeks
Measured: For 5 years after randomization
Pattern of first recurrence
Every 12weeks during the first two years after randomization then every 24weeks
Measured: For 5 years after randomization
The incidence and severity of adverse events according to NCI-CTCAE v5.0
All AEs will be recorded throughout the study, starting from the time of the first dose in the adjuvant therapy arm and from the time of randomization in the surveillance arm, while SAEs will be recorded from the time of signing the Full Study ICF in both arms. Recording will continue up to 30 days after the last dose of study drug (extended to 50 days if the last dose was tislelizumab administered Q6W) or until the initiation of another anticancer therapy, whichever occurs first. For the surveillance arm, AE recording will continue up to the last visit in the Treatment Period (planned up to the 48-week visit after randomization) or until the initiation of a new anticancer therapy, whichever occurs first.
Measured: From the time of the first administration up to 30 days after the last administration (up to 50 days if the last administration was at a 6-week interval)
Patient-Reported Outcomes -measured Health-related quality of life
- The Patient-Reported Outcomes are assessed at the following timepoints until two years after randomization:
- Treatment Period:
- Adjuvant therapy arm:
- Participants receiving adjuvant chemoimmunotherapy: prior to study treatment on Day 1 of Cycle 1 of the paclitaxel/carboplatin/tislelizumab regimen, prior to dosing at Cycle 5, Cycle 7, and Cycle 9 of tislelizumab monotherapy, and at the EOT/Safety Follow-up visit
- Participants receiving adjuvant chemoradioimmunotherapy: prior to study treatment on Day 1 of the Cycle 1 of the paclitaxel/carboplatin/tislelizumab regimen, prior to dosing at Cycle 4, Cycle 6, and Cycle 8 of tislelizumab monotherapy, and at the EOT/Safety Follow-up visit
- Surveillance arm: within 7 days after randomization, and at visits at 12W, 24W, 36W, and 48W after randomization.
- Follow-up Period:
Every 12 weeks (± 14 days) during the first two years after randomization
Measured: For 2 years after randomization
ctDNA clearance during and after adjuvant treatment as a predictive biomarker for adjuvant treatment efficacy, and ctDNA clearance during surveillance as a prognostic biomarker
Every 12weeks during the first two years after randomization
Measured: For 2 years after randomization
Time to ctDNA clearance during and after adjuvant treatment as a predictive biomarker for adjuvant treatment efficacy, and time to ctDNA clearance during surveillance as a prognostic biomarker
Every 12weeks during the first two years after randomization
Measured: For 2 years after randomization
Longitudinal changes in ctDNA until clearance during and after adjuvant treatment as a predictive biomarker for adjuvant treatment efficacy, and longitudinal changes in ctDNA until clearance during surveillance as a prognostic biomarker
Every 12weeks during the first two years after randomization
Measured: For 2 years after randomization
ctDNA levels as a predictive biomarker for treatment efficacy and as a prognostic biomarker
Every 12weeks during the first two years after randomization
Measured: For 2 years after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Dec 202630 May 2034

First posted6 Apr 2025
Study start31 Dec 2026 (estimated)
Primary completion28 Jun 2031 (estimated)
Study completion30 May 2034 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Esophageal CancerStudies of the same condition, open and under way.
More trials run by Asan Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 172 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06914011
Sponsor's protocol ID: 2025-0183
Acronym: MRD2START
Status last verified: Oct 2026
First submitted: 31 Mar 2025
Last updated: 29 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Yang H, Liu H, Chen Y, Zhu C, Fang W, Yu Z, Mao W, Xiang J, Han Y, Chen Z, Yang H, Wang J, Pang Q, Zheng X, Yang H, Li T, Lordick F, D'Journo XB, Cerfolio RJ, Korst RJ, Novoa NM, Swanson SJ, Brunelli A, Ismail M, Fernando HC, Zhang X, Li Q, Wang G, Chen B, Mao T, Kong M, Guo X, Lin T, Liu M, Fu J; AME Thoracic Surgery Collaborative Group. Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Squamous Cell Carcinoma of the Esophagus (NEOCRTEC5010): A Phase III Multicenter, Randomized, Open-Label Clinical Trial. J Clin Oncol. 2018 Sep 20;36(27):2796-2803. doi: 10.1200/JCO.2018.79.1483. Epub 2018 Aug 8.
PubMed 30089078
Shapiro J, van Lanschot JJB, Hulshof MCCM, van Hagen P, van Berge Henegouwen MI, Wijnhoven BPL, van Laarhoven HWM, Nieuwenhuijzen GAP, Hospers GAP, Bonenkamp JJ, Cuesta MA, Blaisse RJB, Busch ORC, Ten Kate FJW, Creemers GM, Punt CJA, Plukker JTM, Verheul HMW, Bilgen EJS, van Dekken H, van der Sangen MJC, Rozema T, Biermann K, Beukema JC, Piet AHM, van Rij CM, Reinders JG, Tilanus HW, Steyerberg EW, van der Gaast A; CROSS study group. Neoadjuvant chemoradiotherapy plus surgery versus surgery alone for oesophageal or junctional cancer (CROSS): long-term results of a randomised controlled trial. Lancet Oncol. 2015 Sep;16(9):1090-1098. doi: 10.1016/S1470-2045(15)00040-6. Epub 2015 Aug 5.
PubMed 26254683
van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088.
PubMed 22646630
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338

Interested in taking part?

Sook Ryun Park, MD, Ph.D

82-2-3010-3206

srpark@amc.seoul.kr

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer

All Esophageal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-center, Randomized, Phase III Trial of Circulating Tumor DNA MRD-Guided Adjuvant Therapy for Curatively Resected Locally Advanced Esophageal Squamous Cell Carcinoma (MRD2START)
ClinicalTrials.gov ID: NCT06914011
Acronym / sponsor ID: MRD2START / 2025-0183
Conditions: Esophageal Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 172 participants (estimated)
Lead sponsor: Asan Medical CenterUniversity, hospital or other
Study start: 31 Dec 2026 (estimated)
Primary completion: 28 Jun 2031 (estimated)
Study completion: 30 May 2034 (estimated)
First posted: 6 Apr 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Patients found to be MRD-positive will be randomly allocated in a 2:1 ratio to either an adjuvant therapy arm or a surveillance arm.

Randomization will be stratified based on the administration of pre-surgery neoadjuvant therapy (yes vs. no), the pathological stage after surgery (0-2 vs. 3-4), and institution.

MRD-negative patients are excluded from the phase 3 trial. Instead, they will receive routine clinical care and are monitored as part of a separate observational study.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Adjuvant therapy arm	Experimental	Drug: TislelizumabFor participants assigned the adjuvant therapy arm, those who underwent neoadjuvant chemoradiotherapy followed by surgery will receive adjuvant chemoimmunotherapy. For patients who underwent neoadjuvant chemotherapy followed by surgery, or upfront surgery without prior neoadjuvant therapy, the choice between Option 1 (adjuvant chemoradioimmunotherapy) and Option 2 (adjuvant chemoimmunotherapy) will be made at the investigator's discretion. Adjuvant chemoradioimmunotherapy.
Surveillance arm	No intervention	–Surveillance arm will be followed up without any adjuvant therapy, undergoing CT scans every 12 weeks during the first 2 years after randomization, and thereafter every 24 weeks until 5 years after randomization

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (24 listed)

1. Be willing and able to provide written informed consent. 2. Be ≥19 years of age on the day of signing the informed consent form. 3. Have ECOG performance status of 0 or 1 (Appendix 1). 4. Have a histologically confirmed diagnosis of squamous cell carcinoma of the esophagus
5. Must have completed surgical resection for localized disease, either with prior neoadjuvant therapy (chemotherapy or chemoradiotherapy) or without prior neoadjuvant therapy (i.e., upfront surgery), in accordance with the 8th edition of the AJCC staging system (Appendix 2). Exceptionally, cases with supraclavicular lymph node metastasis as the only M1 lesion are also eligible if the lymph node has been surgically removed.
6. Must have undergone curative surgery (R0 resection) with negative margins on the resected specimen.
7. Complete resection must have been performed between 4-16 weeks before randomization.
8. Must have a documented disease-free status based on a complete physical examination and imaging studies within 4 weeks before randomization. Imaging studies must include CT scans (or MRI) of the chest, abdomen, and pelvis.

Key exclusion criteria (25 listed)

1. Documented recurrence of esophageal cancer before randomization following curative resection.
2. Receipt of any treatment aimed at the resected esophageal cancer after curative surgery, including chemotherapy, targeted therapy, immunotherapy, radiotherapy, biologic therapy, investigational agent, or local therapies, except for procedures intended for palliative care (e.g., stent insertion, balloon dilatation, or feeding enterostomy).
3. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) inhibitor, or any other drug targeting T-cell co-stimulation or checkpoint pathways.
4. Active autoimmune disease requiring systemic treatment within the 2 years prior to study entry (i.e., using disease-modifying agents, corticosteroids, or immunosuppressive drugs).
5. Condition requiring systemic treatment with corticosteroids (>10 mg daily prednisone or equivalent) or any other form of immunosuppressive therapy within 14 days prior to study entry.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TislelizumabAlso: Paclitaxel, Carboplatin1. Option 1: adjuvant chemoradioimmunotherapy in the following sequence: * Cycle 1: Tislelizumab 200 mg iv D1, Paclitaxel 175 mg/m2 iv D1, and Carboplatin AUC 5 mg/mL/min iv D1, in a 3-week cycle for one cycle * Cycle 2: Concurrent radiotherapy (25 fractions of 1.8 Gy each, with 5 fractions per week) with Tislelizumab 200 mg iv D1, D22, Paclitaxel 50 mg/m2 iv D1, 8, 15, 22, 29, and Carboplatin AUC 2 mg/mL/min D1, 8, 15, 22, 29 * Cycle 3: Tislelizumab 200 mg iv D1, Paclitaxel 175 mg/m2 iv D1, and Carboplatin AUC 5 mg/mL/min iv D1, in a 3-week cycle for 1 cycle * Cycles 4-9: Tislelizumab 400 mg iv D1, in a 6-week cycle for six cycles 2. Option 2: adjuvant chemoimmunotherapy in the following sequence: * Cycles 1-4: Tislelizumab 200 mg iv D1, Paclitaxel 175 mg/m2 iv D1, and Carboplatin AUC 5 mg/mL/min iv D1, in a 3-week cycle for four cycles * Cycles 5-10: Tislelizumab 400 mg iv D1, in a 6-week cycle for six cycles	Drug	Adjuvant therapy arm

Primary outcome

Recurrence-free survival as assessed by the investigator
Time frame: For 5 years after randomization
Every 12weeks during the first two years after randomization then every 24weeks

10 secondary outcomes

Overall survival
Time frame: For 5 years after randomization
Distant metastasis-free survival
Time frame: For 5 years after randomization
Locoregional Recurrence-free survival
Time frame: For 5 years after randomization
Pattern of first recurrence
Time frame: For 5 years after randomization
The incidence and severity of adverse events according to NCI-CTCAE v5.0
Time frame: From the time of the first administration up to 30 days after the last administration (up to 50 days if the last administration was at a 6-week interval)
Patient-Reported Outcomes -measured Health-related quality of life
Time frame: For 2 years after randomization
ctDNA clearance during and after adjuvant treatment as a predictive biomarker for adjuvant treatment efficacy, and ctDNA clearance during surveillance as a prognostic biomarker
Time frame: For 2 years after randomization
Time to ctDNA clearance during and after adjuvant treatment as a predictive biomarker for adjuvant treatment efficacy, and time to ctDNA clearance during surveillance as a prognostic biomarker
Time frame: For 2 years after randomization
Longitudinal changes in ctDNA until clearance during and after adjuvant treatment as a predictive biomarker for adjuvant treatment efficacy, and longitudinal changes in ctDNA until clearance during surveillance as a prognostic biomarker
Time frame: For 2 years after randomization
ctDNA levels as a predictive biomarker for treatment efficacy and as a prognostic biomarker
Time frame: For 2 years after randomization

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
Results publication: PubMed 30089078Yang H, Liu H, Chen Y, Zhu C, Fang W, Yu Z, Mao W, Xiang J, Han Y, Chen Z, Yang H, Wang J, Pang Q, Zheng X, Yang H, Li T, Lordick F, D'Journo XB, Cerfolio RJ, Korst RJ, Novoa NM, Swanson SJ, Brunelli A, Ismail M, Fernando HC, Zhang X, Li Q, Wang G, Chen B, Mao T, Kong M, Guo X, Lin T, Liu M, Fu J; AME Thoracic Surgery Collaborative Group. Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Squamous Cell Carcinoma of the Esophagus (NEOCRTEC5010): A Phase III Multicenter, Randomized, Open-Label Clinical Trial. J Clin Oncol. 2018 Sep 20;36(27):2796-2803. doi: 10.1200/JCO.2018.79.1483. Epub 2018 Aug 8.
Results publication: PubMed 26254683Shapiro J, van Lanschot JJB, Hulshof MCCM, van Hagen P, van Berge Henegouwen MI, Wijnhoven BPL, van Laarhoven HWM, Nieuwenhuijzen GAP, Hospers GAP, Bonenkamp JJ, Cuesta MA, Blaisse RJB, Busch ORC, Ten Kate FJW, Creemers GM, Punt CJA, Plukker JTM, Verheul HMW, Bilgen EJS, van Dekken H, van der Sangen MJC, Rozema T, Biermann K, Beukema JC, Piet AHM, van Rij CM, Reinders JG, Tilanus HW, Steyerberg EW, van der Gaast A; CROSS study group. Neoadjuvant chemoradiotherapy plus surgery versus surgery alone for oesophageal or junctional cancer (CROSS): long-term results of a randomised controlled trial. Lancet Oncol. 2015 Sep;16(9):1090-1098. doi: 10.1016/S1470-2045(15)00040-6. Epub 2015 Aug 5.
Results publication: PubMed 22646630van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088.
Results publication: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
Individual participant dataSharing planned: No

Related trials for Esophageal Cancer

RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Sook Ryun Park, MD, Ph.D contact

82-2-3010-3206

srpark@amc.seoul.kr

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tislelizumab in people with Esophageal Cancer, run by Asan Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sook Ryun Park, MD, Ph.D (82-2-3010-3206, srpark@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence-free survival as assessed by the investigator (time frame: For 5 years after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06914011, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.