Esophageal Squamous Cell Carcinoma (ESCC)Phase 2NCT07039162
Study of Tislelizumab Combined With Chemoradiotherapy and Surgery for Unresectable Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Tislelizumab, Paclitaxel and Cisplatin in people with Esophageal Squamous Cell Carcinoma (ESCC) and Locally Advanced Unresectable Esophageal Cancer, run by Ming-Yu Lien at 8 sites in Taiwan.
Trial summary
This is a Phase II, open-label, single-arm, multicenter study evaluating the safety and efficacy of combining Tislelizumab with induction chemoradiotherapy (CRT), followed by conversion surgery, in patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma (ESCC), Locally Advanced Unresectable Esophageal Cancer
- What is being tested?
- Tislelizumab, Paclitaxel and Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 8 sitesTaiwan
- Study dates
- 26 Sep 2025to 31 Dec 2028
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients had histologically confirmed, squamous-cell carcinoma of the esophagus
- Clinical T4 cancer, at least one unresectable metastatic regional lymph node due to invasion into an adjacent organ, or computed tomographic (CT) evidence of M1Lym, such as fixed supraclavicular nodes. Regional lymph nodes are defined on the basis of criteria specified by the eighth edition of the Union for International Cancer Control TNM staging system (Sobin and Wittekind, 2016).
- An age of at least 20 years
- An Eastern Cooperative Oncology Group performance-status score 0 or 1
- Adequate major organ functions
- WBC ≥3,500/mm3
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- Hemoglobin ≥ 9.0 g/dL
- Platelet ≥ 80,000/mm3
- Total bilirubin ≤ 2-fold the upper limit of normal (ULN)
- ALT and AST ≤ 5-fold the ULN AND ≤200 U/L
- PT, aPTT and INR ≤1.5-fold the ULN
- Albumin ≥2.5 g/dL
- Creatinine clearance ≥50 ml/min (based upon 24 hours urine collection or calculated by Cockroft-Gault formula)
- Male: ((140 - age) × weight [kg])/(72 × serum creatinine [mg/dL])
- Female: 0.85 x estimate for male
- Women of childbearing potential (including women with chemical menopause or no menstruation for other medical reasons) must agree to use contraception from the time of informed consent until 5 months or more after the last dose of investigational products. (Women of childbearing potential are defined as all women after the onset of menstruation who are not postmenopausal and have not been surgically sterilized (e.g., hysterectomy, bilateral tubal ligation, bilateral oophorectomy). Postmenopause is defined as amenorrhea for ≥12 consecutive months without specific reasons.)
- Men must agree to use contraception from the start of study treatment until 3 months or more after the last dose of the investigational product.
- Patients must be willing to undergo definitive resection with lymph node dissection
- Participants must have signed written informed consent form in accordance with regulatory and institutional guidelines.
Who cannot join
- Patient has received systemic therapy for advanced ESCC.
- Patients had distant metastasis, including liver, lung, bone and brain metastases.
- Patients had esophageal perforation or esophageal fistula
- Patients had tumor bleeding
- Patients had active infection(e.g. tuberculosis).
- History or known human immunodeficiency virus.
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- Subjects with active, known, or suspected autoimmune disease. Subjects with Type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll.
- Systemic immunosuppression therapy or chronic systemic steroid therapy (more than 10mg daily of prednisolone)
- Known hepatitis B (HBsAg reactive) or C virus infection (positive anti HCV)
- Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA < 500 IU/mL or < 2500 copies/mL) can be enrolled. Patients with detectable HBsAg or detectable HBV DNA should be managed per treatment guidelines. Patients receiving antivirals at screening should have been treated for > 2 weeks before randomization/enrollment.
- Patients with a positive HCV antibody test followed by a negative HCV RNA test at screening are eligible.
- Previous therapy targeting T-cell costimulating or immune-checkpoint pathways
- Prior or concurrent malignancies within the last 3 years, with the exception of carcinoma in situ of the cervix, or basal type skin cancer
- Any major surgery within 4 weeks before study enrollment.
- Pregnant women or nursing mothers, or positive pregnancy tests
- Patients had allogeneic stem cell transplantation or organ transplantation.
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including NYHA Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention.
- Patients with interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, or acute lung diseases
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
- Other patients judged by the investigators be inappropriate as subjects of this study
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Taiwan8 sites, 8 recruiting
- Not yet recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Shau-Hsuan Li, 0975-056058, lee056058@gmail.com
- Not yet recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Yao-Kuang Wang, 07-3121101#7451, minicawu@gmail.com
- Recruiting
China Medical University Hospital
Taichung, 404
Ming-Yu Lien, 0975680832, leinmirain@hotmail.com
- Not yet recruiting
Taichung Veterans General Hospital
Taichung, 407219
Cheng-Wei Chou, MD, +886-4-2359-2525 ext. 3175, ccwei@vghtc.gov.tw
- Not yet recruiting
National Cheng Kung University Hospital
Tainan
Chia-Jui Yen, 06-2353535-6550, yencj@mail.ncku.edu.tw
- Not yet recruiting
National Taiwan University Hospital
Taipei, 100225
Chih-Hung Hsu, MD, 886-2-2312-3456 ext. 67680, chihhunghsu@ntu.edu.tw
- Not yet recruiting
Taipei Veterans General Hospital
Taipei
Ming-Huang Chen, 02-28757529, lweisiou@gmail.com
- Not yet recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan, 33305
Ming-Mo Hou, MD, 0975-366138, student871029@gmail.com
About this study
Official title: Phase II Study of Tislelizumab Combined With Induction Chemoradiotherapy and Subsequent Conversion Surgery for Locally Advanced Unresectable ESCC
This is a Phase II, open-label, single-arm, multicenter study evaluating the safety and efficacy of combining Tislelizumab with induction chemoradiotherapy (CRT), followed by conversion surgery, in patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC).
Patients will receive induction CRT with weekly paclitaxel and cisplatin along with Tislelizumab, followed by two cycles of consolidation Tislelizumab-chemotherapy. If the tumor becomes resectable, patients will undergo surgery.
The primary goal is to assess the 2-year overall survival (OS) rate. Secondary outcomes include pathological complete response (pCR), conversion rate, R0 resection rate, disease-free survival (DFS), recurrence-free survival (RFS), and treatment-related adverse events.
- Conditions
- Esophageal Squamous Cell Carcinoma (ESCC), Locally Advanced Unresectable Esophageal Cancer
- Being tested
- Tislelizumab, Paclitaxel, Cisplatin, Radiation Therapy
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
- ICRT phase -Tislelizumab and CRT regimen Tislelizumab 200 mg IV, C1D1 and C4D1
- Consolidation phase: Tislelizumab-Paclitaxel-Cisplatin regimen Tislelizumab 200 mg IV, D1, every 3 weeks (*The regimen is repeated until unacceptable toxicity or disease progression, up to maximum of 2 cycles. )
- Adjuvant phase-Tislelizumab Tislelizumab 200 mg IV, D1, every 3 weeks (*The regimen is repeated until unacceptable toxicity or disease progression, up to maximum of one year or 17 cycles.)
PaclitaxelDrug
- ICRT phase -Tislelizumab and CRT regimen Paclitaxel 50 mg/m2 IV, D1, weekly (* 4-6 cycles judged by investigators.)
- Consolidation phase: Tislelizumab-Paclitaxel-Cisplatin regimen Paclitaxel 135 mg/m2 IV, D1, every 3 weeks (*The regimen is repeated until unacceptable toxicity or disease progression, up to maximum of 2 cycles.)
CisplatinDrug
- ICRT phase -Tislelizumab and CRT regimen Cisplatin 25 mg/m2 IV, D1, weekly ( 4-6 cycles judged by investigators.)
- Consolidation phase: Tislelizumab-Paclitaxel-Cisplatin regimen Cisplatin 75 mg/m2 IV, D1, every 3 weeks (*The regimen is repeated until unacceptable toxicity or disease progression, up to maximum of 2 cycles. )
Radiation TherapyRadiation
- ICRT phase -Tislelizumab and CRT regimen Radiotherapy treatment: IMRT 41-50.4Gy, a dose of 1.8 to 2Gy per day, 5 days per week for 5 weeks during the RT phase.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Single-arm study: Participants will receive Tislelizumab in combination with chemoradiotherapy (Paclitaxel + Cisplatin) and conversion surgery if the tumor becomes resectable. The treatment sequence involves induction chemoradiotherapy, followed by consolidation chemotherapy and surgery if applicable. Receives: Drug: Tislelizumab; Drug: Paclitaxel; Drug: Cisplatin; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year OS rate
Estimated 2-year OS rate is defined as number of participants alive divided by the number of participants.
Measured: From the date of first treatment (induction chemoradiotherapy) to 2 years after treatment initiation.
Secondary outcomes (9)
Pathological complete response (pCR) rate
Pathological complete response (pCR) rate is defined as number of participants with no evidence of residual tumor cells in the primary site and resected lymph nodes of the operative specimens divided by the number of participants received esophagectomy.
Measured: At time of surgery (8 to 12 weeks after completion of induction or consolidation treatment)
Conversion rate
Conversion rate is defined asnumber of participants received esophagectomy divided by the number of participants.
Measured: Assessed within 12 weeks after completion of induction or consolidation treatment.
R0 resection rate
R0 resection rate is defined as the proportion of participants with negative resection margins (greater than 1 mm) among those who underwent esophagectomy following induction chemoradiotherapy and/or consolidation treatment with tislelizumab.
Measured: Assessed at time of surgery (8 to 12 weeks after completion of induction or consolidation treatment)
Disease-free survival (DFS)
Disease-free survival (DFS) is defined as the time from enrollment until evidence of disease recurrence or death.
Measured: From enrollment until disease recurrence or death, whichever occurs first, assessed up to 2 years.
Event-free survival (EFS)
Event-free survival (EFS) is defined as the time from enrollment to an event which may include radiographic progression, clinical progression, 2nd aerodigestive tract squamous cell carcinoma, and death.
Measured: From date of enrollment to first documented event or death, assessed up to 2 years.
Distant metastasis-free survival (DMFS)
Distant metastasis-free survival (DMFS) is defined as the time from enrollment until evidence of distant metastasis recurrence or death.
Measured: From date of enrollment to first documented distant metastasis or death, assessed up to 2 years
Overall survival (OS)
Overall survival (OS) is defined as the time from enrollment to death
Measured: From date of enrollment to death, assessed up to 2 years
Recurrence-free survival (RFS)
Recurrence-free survival (RFS) is Measure the length of time that patients remain free of disease recurrence or progression following initial treatment.
Measured: From date of initial treatment to first documented recurrence or death, assessed up to 2 years
Adverse events
Adverse events related to protocol immunotherapy, chemotherapy, radiotherapy and conversion surgery .
Measured: From the date of informed consent until the completion of study treatment and follow-up period, up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start26 Sep 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell Carcinoma (ESCC)Studies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ming-Yu Lien
- Sponsor type
- University, hospital or other
- Collaborators
- BeiGene
- Responsible party
- Sponsor-investigator, Ming-Yu Lien, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039162
- Sponsor's protocol ID
- CMUH-BGB-A317-CS01
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Tislelizumab Combined With Induction Chemoradiotherapy and Subsequent Conversion Surgery for Locally Advanced Unresectable ESCC
- ClinicalTrials.gov ID
- NCT07039162
- Acronym / sponsor ID
- CMUH-BGB-A317-CS01
- Conditions
- Esophageal Squamous Cell Carcinoma (ESCC), Locally Advanced Unresectable Esophageal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Ming-Yu LienUniversity, hospital or other
- Collaborators
- BeiGene
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 Jun 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.
This is a Phase II, open-label, single-arm, multicenter study evaluating the safety and efficacy of combining Tislelizumab with induction chemoradiotherapy (CRT), followed by conversion surgery, in patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC).
Patients will receive induction CRT with weekly paclitaxel and cisplatin along with Tislelizumab, followed by two cycles of consolidation Tislelizumab-chemotherapy. If the tumor becomes resectable, patients will undergo surgery.
The primary goal is to assess the 2-year overall survival (OS) rate. Secondary outcomes include pathological complete response (pCR), conversion rate, R0 resection rate, disease-free survival (DFS), recurrence-free survival (RFS), and treatment-related adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Tislelizumab, Drug: Paclitaxel, Drug: Cisplatin, Radiation: Radiation TherapySingle-arm study: Participants will receive Tislelizumab in combination with chemoradiotherapy (Paclitaxel + Cisplatin) and conversion surgery if the tumor becomes resectable. The treatment sequence involves induction chemoradiotherapy, followed by consolidation chemotherapy and surgery if applicable. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients had histologically confirmed, squamous-cell carcinoma of the esophagus
- Clinical T4 cancer, at least one unresectable metastatic regional lymph node due to invasion into an adjacent organ, or computed tomographic (CT) evidence of M1Lym, such as fixed supraclavicular nodes. Regional lymph nodes are defined on the basis of criteria specified by the eighth edition of the Union for International Cancer Control TNM staging system (Sobin and Wittekind, 2016).
- An age of at least 20 years
- An Eastern Cooperative Oncology Group performance-status score 0 or 1
- Adequate major organ functions
Key exclusion criteria (20 listed)
- Patient has received systemic therapy for advanced ESCC.
- Patients had distant metastasis, including liver, lung, bone and brain metastases.
- Patients had esophageal perforation or esophageal fistula
- Patients had tumor bleeding
- Patients had active infection(e.g. tuberculosis).
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 |
|---|---|---|
| Tislelizumab1. ICRT phase -Tislelizumab and CRT regimen Tislelizumab 200 mg IV, C1D1 and C4D1 2. Consolidation phase: Tislelizumab-Paclitaxel-Cisplatin regimen Tislelizumab 200 mg IV, D1, every 3 weeks (*The regimen is repeated until unacceptable toxicity or disease progression, up to maximum of 2 cycles. ) 3. Adjuvant phase-Tislelizumab Tislelizumab 200 mg IV, D1, every 3 weeks (*The regimen is repeated until unacceptable toxicity or disease progression, up to maximum of one year or 17 cycles.) | Drug | Arm 1 |
| Paclitaxel1. ICRT phase -Tislelizumab and CRT regimen Paclitaxel 50 mg/m2 IV, D1, weekly (* 4-6 cycles judged by investigators.) 2. Consolidation phase: Tislelizumab-Paclitaxel-Cisplatin regimen Paclitaxel 135 mg/m2 IV, D1, every 3 weeks (*The regimen is repeated until unacceptable toxicity or disease progression, up to maximum of 2 cycles.) | Drug | Arm 1 |
| Cisplatin1. ICRT phase -Tislelizumab and CRT regimen Cisplatin 25 mg/m2 IV, D1, weekly ( 4-6 cycles judged by investigators.) 2. Consolidation phase: Tislelizumab-Paclitaxel-Cisplatin regimen Cisplatin 75 mg/m2 IV, D1, every 3 weeks (*The regimen is repeated until unacceptable toxicity or disease progression, up to maximum of 2 cycles. ) | Drug | Arm 1 |
| Radiation Therapy1. ICRT phase -Tislelizumab and CRT regimen Radiotherapy treatment: IMRT 41-50.4Gy, a dose of 1.8 to 2Gy per day, 5 days per week for 5 weeks during the RT phase. | Radiation | Arm 1 |
Primary outcome
2-year OS rate
Time frame: From the date of first treatment (induction chemoradiotherapy) to 2 years after treatment initiation.
Estimated 2-year OS rate is defined as number of participants alive divided by the number of participants.
9 secondary outcomes
Pathological complete response (pCR) rate
Time frame: At time of surgery (8 to 12 weeks after completion of induction or consolidation treatment)
Conversion rate
Time frame: Assessed within 12 weeks after completion of induction or consolidation treatment.
R0 resection rate
Time frame: Assessed at time of surgery (8 to 12 weeks after completion of induction or consolidation treatment)
Disease-free survival (DFS)
Time frame: From enrollment until disease recurrence or death, whichever occurs first, assessed up to 2 years.
Event-free survival (EFS)
Time frame: From date of enrollment to first documented event or death, assessed up to 2 years.
Distant metastasis-free survival (DMFS)
Time frame: From date of enrollment to first documented distant metastasis or death, assessed up to 2 years
Overall survival (OS)
Time frame: From date of enrollment to death, assessed up to 2 years
Recurrence-free survival (RFS)
Time frame: From date of initial treatment to first documented recurrence or death, assessed up to 2 years
Adverse events
Time frame: From the date of informed consent until the completion of study treatment and follow-up period, up to 2 years.
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 27 Feb 2026.
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab, Paclitaxel and Cisplatin in people with Esophageal Squamous Cell Carcinoma (ESCC) and Locally Advanced Unresectable Esophageal Cancer, run by Ming-Yu Lien at 8 sites in Taiwan.
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 19 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Ming-Yu Lein, MD (0975680832, leinmirain@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year OS rate (time frame: From the date of first treatment (induction chemoradiotherapy) to 2 years after treatment initiation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2026.