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Esophageal Squamous Cell CarcinomaPhase 2NCT06281886

Induction Immuno-chemotherapy and Concurrent Chemoradiotherapy With or Without Apatinib in Unresectable, Locally Advanced Esophageal Squamous Cell Carcinoma

A Phase 2 study testing Induction Immunotherapy-Toripalimab, Induction Chemotherapy-Albumin-paclitaxel combined with cisplatin and Radiotherapy in people with Esophageal Squamous Cell Carcinoma and Efficacy, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label, randomized, controlled phase II study evaluating induction immuno-chemotherapy and concurrent chemoradiotherapy with or without apatinib in unresectable, locally advanced esophageal squamous cell carcinoma Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Induction Immunotherapy-Toripalimab, Induction Chemotherapy-Albumin-paclitaxel combined with cisplatin and Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
1 siteChina
Study dates
15 Feb 2024to 25 Jun 2026
Phase
Phase 2
Are there results?
None posted in the registry

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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with esophageal squamous cell carcinoma through pathological examination or cytological examination;
  • Evaluated as locally advanced esophageal cancer that is unresectable through endoscopic ultrasound, imaging studies including barium swallow, CT scans of the neck, chest, and upper abdomen, MR imaging of the neck and chest, whole-body bone scan, or PET/CT, with staging ranging from T2-4, N0-3, M0-1 (M1 only includes patients with supraclavicular lymph node metastasis);
  • Male or female aged between 18 and 80 years old;
  • No prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy;
  • Expected survival of ≥12 weeks;
  • ECOG performance status score of 0 or 1;
  • Organ and bone marrow function meeting the following criteria: forced expiratory volume in 1 second (FEV1) ≥800 ml; absolute neutrophil count ≥1.5×109/L; platelet count ≥100×109/L; hemoglobin ≥90 g/L; serum creatinine clearance calculated according to the Cockcroft-Gault formula ≥50 mL/min (Cockcroft and Gault 1976); serum bilirubin ≤1.5 times the upper limit of normal (ULN); aspartate aminotransferase and alanine aminotransferase ≤2.5 times ULN;
  • Signed and dated informed consent form is required before any study procedures are performed.

Who cannot join

  • Participating in another clinical study concurrently, unless it is an observational (non-interventional) clinical study;
  • Prior use of any targeted therapy or immunotherapy;
  • Underwent major surgery (excluding vascular access) within 4 weeks before entering the study;
  • Uncontrolled complications, including but not limited to persistent or active infections, symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, arrhythmias, active peptic ulcer disease or gastritis, intestinal perforation, intestinal obstruction, active bleeding disorders, or psychiatric illness/social situations that would limit compliance with study requirements or impair the ability to provide written informed consent;
  • Performance status score of 2-4;
  • Any of the following organ and bone marrow dysfunctions: forced expiratory volume in 1 second (FEV1) <1000ml; absolute neutrophil count <1.5×109/L; platelet count <100×109/L; hemoglobin <90 g/L; serum creatinine clearance calculated according to the Cockcroft-Gault formula <50 mL/min (Cockcroft and Gault 1976); serum bilirubin >1.5 times the upper limit of normal (ULN); aspartate aminotransferase and alanine aminotransferase >2.5 times ULN;
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  • Conditions that may interfere with the assessment of the efficacy or safety of apatinib;
  • Use of immunosuppressive drugs within 28 days before the first infusion of trastuzumab, excluding physiologic doses of inhaled corticosteroids; or systemic corticosteroids ≤10 mg/d of prednisone or equivalent;
  • History of autoimmune diseases within the past 2 years;
  • History of active or inflammatory bowel disease (such as Crohn's disease, ulcerative colitis);
  • History of organ transplantation requiring immunosuppressive therapy;
  • Receipt of attenuated live vaccines within 30 days before the study initiation or within 30 days after receiving trastuzumab;
  • History of another primary malignancy within 5 years before starting trastuzumab, except adequately treated basal or squamous cell skin cancer or in situ cervical cancer;
  • Pregnant or lactating females; or sexually active males or females of reproductive potential not using effective contraception methods.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: Induction Immuno-chemotherapy and Concurrent Chemoradiotherapy With or Without Apatinib in Unresectable, Locally Advanced Esophageal Squamous Cell Carcinoma: a Open-label, Randomized, Controlled Phase II Clinical Trial

This is an open-label, randomized, controlled phase II study evaluating induction immuno-chemotherapy and concurrent chemoradiotherapy with or without apatinib in unresectable, locally advanced esophageal squamous cell carcinoma

Read the detailed description

This is an open-label, randomized, controlled phase II study evaluating induction immuno-chemotherapy and concurrent chemoradiotherapy with or without apatinib in unresectable, locally advanced esophageal squamous cell carcinoma. In this study, patients are 1:1 randomized to either the study group or the control group. Patients in the study group will receive apatinib during induction immuno-chemotherapy and concurrent chemoradiotherapy. Patients in the control group will receive induction immuno-chemotherapy and concurrent chemoradiotherapy alone.

Being tested
Induction Immunotherapy-Toripalimab, Induction Chemotherapy-Albumin-paclitaxel combined with cisplatin, Radiotherapy, Apatinib, Capecitabine
Keywords
Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma, Induction immuno-chemotherapy, Concurrent chemoradiotherapy, Apatinib, Survival outcomes, Toxicity
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.

  • Induction Immunotherapy-ToripalimabDrug

    Toripalimab 240mg iv. drip, Q3W, 2 cycles

  • Induction Chemotherapy-Albumin-paclitaxel combined with cisplatinDrug

    Albumin-paclitaxel 260 mg/m2, administered on day 1, combined with cisplatin 25 mg/m2, administered on day 1,2,3.

  • RadiotherapyRadiation

    Thoracic radiotherapy at a total dose of 50Gy was delivered using the intensity modulated radiation therapy technique.

  • ApatinibDrug

    Oral apatinib 250mg once daily during induction therapy and concurrent chemoradiotherapy.

  • CapecitabineDrug

    Also called Chemotherapy concurrently with radiotherapy

    Oral capecitabine 1000 mg/m2, twice daily, on days 1-14, every 3 weeks, concurrently with radiotherapy

Study groups in NCT06281886
Study groupRoleWhat they receive
The study groupExperimentalPatients are planned to receive 2 cycles of induction immuno-chemotherapy plus apatinib, followed by concurrent chemoradiotherapy plus apatinib.
Receives: Drug: Induction Immunotherapy-Toripalimab; Drug: Induction Chemotherapy-Albumin-paclitaxel combined with cisplatin; Radiation: Radiotherapy; Drug: Apatinib; Drug: Capecitabine
The control groupActive comparatorPatients are planned to receive 2 cycles of induction immuno-chemotherapy, followed by concurrent chemoradiotherapy.
Receives: Drug: Induction Immunotherapy-Toripalimab; Drug: Induction Chemotherapy-Albumin-paclitaxel combined with cisplatin; Radiation: Radiotherapy; Drug: Capecitabine

What is being measured

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

  1. Progression free survival rate

    From the first day of treatment to the day of progression or the day of death.

    Measured: 1 year

Secondary outcomes (6)

  1. Overall survival

    It was calculated from the first day of treatment to the day of death.

    Measured: 1 year

  2. Objective response rate

    The proportion of patients evaluated as CR or PR

    Measured: 1 year

  3. Local-regional progression-free survival

    Local-regional progression-free survival refers to the period from the initiation of treatment until the occurrence of progression in the primary site or locoregional lymph node regions.

    Measured: 1 year

  4. Incidence of Treatment-related Adverse Events

    Adverse effects are graded according to the CTCAE 5.0 version, including multiple organs and tissues, such as gastrointestinal disease and symptom, cardiovascular disease, respiratory diseases and so on.

    Measured: 1 year

  5. Score of Quality of Life Questionnare-Core 30 (The European Organization for Reasearch and Treatment of Cancer)

    The evaluation of life quality

    Measured: 1 year

  6. Distant metastasis-free survival

    Distant metastasis-free survival refers to the period from the initiation of treatment until the appearance of metastasis in distant organs or tissues.

    Measured: 1 year

Timeline

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

  1. First posted28 Feb 2024
  2. Study start15 Feb 2024
  3. Primary completion25 Jun 2026
  4. Study completion25 Jun 2026

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06281886
Sponsor's protocol ID
GASTO-10107
Status last verified
Jul 2026
First submitted
13 Feb 2024
Last updated
3 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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

  • Cooper JS, Guo MD, Herskovic A, Macdonald JS, Martenson JA Jr, Al-Sarraf M, Byhardt R, Russell AH, Beitler JJ, Spencer S, Asbell SO, Graham MV, Leichman LL. Chemoradiotherapy of locally advanced esophageal cancer: long-term follow-up of a prospective randomized trial (RTOG 85-01). Radiation Therapy Oncology Group. JAMA. 1999 May 5;281(17):1623-7. doi: 10.1001/jama.281.17.1623.

    PubMed 10235156

  • Minsky BD, Pajak TF, Ginsberg RJ, Pisansky TM, Martenson J, Komaki R, Okawara G, Rosenthal SA, Kelsen DP. INT 0123 (Radiation Therapy Oncology Group 94-05) phase III trial of combined-modality therapy for esophageal cancer: high-dose versus standard-dose radiation therapy. J Clin Oncol. 2002 Mar 1;20(5):1167-74. doi: 10.1200/JCO.2002.20.5.1167.

    PubMed 11870157

  • Xu Y, Dong B, Zhu W, Li J, Huang R, Sun Z, Yang X, Liu L, He H, Liao Z, Guan N, Kong Y, Wang W, Chen J, He H, Qiu G, Zeng M, Pu J, Hu W, Bao Y, Liu Z, Ma J, Jiang H, Du X, Hu J, Zhuang T, Cai J, Huang J, Tao H, Liu Y, Liang X, Zhou J, Tao G, Zheng X, Chen M. A Phase III Multicenter Randomized Clinical Trial of 60 Gy versus 50 Gy Radiation Dose in Concurrent Chemoradiotherapy for Inoperable Esophageal Squamous Cell Carcinoma. Clin Cancer Res. 2022 May 2;28(9):1792-1799. doi: 10.1158/1078-0432.CCR-21-3843.

    PubMed 35190815

  • Conroy T, Galais MP, Raoul JL, Bouche O, Gourgou-Bourgade S, Douillard JY, Etienne PL, Boige V, Martel-Lafay I, Michel P, Llacer-Moscardo C, Francois E, Crehange G, Abdelghani MB, Juzyna B, Bedenne L, Adenis A; Federation Francophone de Cancerologie Digestive and UNICANCER-GI Group. Definitive chemoradiotherapy with FOLFOX versus fluorouracil and cisplatin in patients with oesophageal cancer (PRODIGE5/ACCORD17): final results of a randomised, phase 2/3 trial. Lancet Oncol. 2014 Mar;15(3):305-14. doi: 10.1016/S1470-2045(14)70028-2. Epub 2014 Feb 18.

    PubMed 24556041

  • Hulshof MCCM, Geijsen ED, Rozema T, Oppedijk V, Buijsen J, Neelis KJ, Nuyttens JJME, van der Sangen MJC, Jeene PM, Reinders JG, van Berge Henegouwen MI, Thano A, van Hooft JE, van Laarhoven HWM, van der Gaast A. Randomized Study on Dose Escalation in Definitive Chemoradiation for Patients With Locally Advanced Esophageal Cancer (ARTDECO Study). J Clin Oncol. 2021 Sep 1;39(25):2816-2824. doi: 10.1200/JCO.20.03697. Epub 2021 Jun 8.

    PubMed 34101496

  • Suntharalingam M, Winter K, Ilson D, Dicker AP, Kachnic L, Konski A, Chakravarthy AB, Anker CJ, Thakrar H, Horiba N, Dubey A, Greenberger JS, Raben A, Giguere J, Roof K, Videtic G, Pollock J, Safran H, Crane CH. Effect of the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation Therapy for Patients With Esophageal Cancer: The NRG Oncology RTOG 0436 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2017 Nov 1;3(11):1520-1528. doi: 10.1001/jamaoncol.2017.1598.

    PubMed 28687830

  • Shinoda M, Ando N, Kato K, Ishikura S, Kato H, Tsubosa Y, Minashi K, Okabe H, Kimura Y, Kawano T, Kosugi S, Toh Y, Nakamura K, Fukuda H; Japan Clinical Oncology Group. Randomized study of low-dose versus standard-dose chemoradiotherapy for unresectable esophageal squamous cell carcinoma (JCOG0303). Cancer Sci. 2015 Apr;106(4):407-12. doi: 10.1111/cas.12622. Epub 2015 Mar 9.

    PubMed 25640628

  • Zhu Y, Wen J, Li Q, Chen B, Zhao L, Liu S, Yang Y, Wang S, Lv Y, Li J, Zhang L, Hu Y, Liu M, Xi M. Toripalimab combined with definitive chemoradiotherapy in locally advanced oesophageal squamous cell carcinoma (EC-CRT-001): a single-arm, phase 2 trial. Lancet Oncol. 2023 Apr;24(4):371-382. doi: 10.1016/S1470-2045(23)00060-8.

    PubMed 36990609

  • Wang J, Yu JP, Wang JL, Ni XC, Sun ZQ, Sun W, Nie B, Jiang JT, Sun SP, Wu CP. [Pathologic response and changes of serum VEGF during chemoradiotherapy may predict prognosis in non-surgical patients with esophageal carcinoma]. Zhonghua Zhong Liu Za Zhi. 2016 Aug;38(8):589-95. doi: 10.3760/cma.j.issn.0253-3766.2016.08.005. Chinese.

    PubMed 27531478

  • Chu L, Chen Y, Liu Q, Liang F, Wang S, Liu Q, Yu H, Wu X, Zhang J, Deng J, Ai D, Zhu Z, Nie Y, Zhao K. A Phase II Study of Apatinib in Patients with Chemotherapy-Refractory Esophageal Squamous Cell Carcinoma (ESO-Shanghai 11). Oncologist. 2021 Jun;26(6):e925-e935. doi: 10.1002/onco.13668. Epub 2021 Feb 1.

    PubMed 33393167

  • Meng X, Wu T, Hong Y, Fan Q, Ren Z, Guo Y, Yang X, Shi P, Yang J, Yin X, Luo Z, Xia J, Zhou Y, Xu M, Liu E, Jiang G, Li S, Zhao F, Ma C, Ma C, Hou Z, Li J, Wang J, Wang F. Camrelizumab plus apatinib as second-line treatment for advanced oesophageal squamous cell carcinoma (CAP 02): a single-arm, open-label, phase 2 trial. Lancet Gastroenterol Hepatol. 2022 Mar;7(3):245-253. doi: 10.1016/S2468-1253(21)00378-2. Epub 2022 Jan 6.

    PubMed 34998471

  • Chi D, Chen B, Guo S, Bai K, Ma H, Hu Y, Li Q, Zhu Y. Oral maintenance therapy using apatinib combined with S-1/capecitabine for esophageal squamous cell carcinoma with residual disease after definitive chemoradiotherapy. Aging (Albany NY). 2021 Mar 10;13(6):8408-8420. doi: 10.18632/aging.202652. Epub 2021 Mar 10.

    PubMed 33713398

  • Hu L, Sun F, Sun Z, Ni X, Wang J, Wang J, Zhou M, Feng Y, Kong Z, Hua Q, Yu J. Apatinib enhances the radiosensitivity of the esophageal cancer cell line KYSE-150 by inducing apoptosis and cell cycle redistribution. Oncol Lett. 2019 Feb;17(2):1609-1616. doi: 10.3892/ol.2018.9803. Epub 2018 Dec 6.

    PubMed 30675220

  • Hu L, Kong Z, Meng Q, Wang J, Zhou M, Yu J, Jiang X. The Safety and Efficacy of Apatinib Treatment in Addition to Concurrent Chemoradiotherapy in Patients with Nonoperative Locally Advanced Esophageal Squamous Cell Carcinoma. Med Sci Monit. 2020 Nov 27;26:e927221. doi: 10.12659/MSM.927221.

    PubMed 33243967

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Induction Immunotherapy-Toripalimab, Induction Chemotherapy-Albumin-paclitaxel combined with cisplatin and Radiotherapy in people with Esophageal Squamous Cell Carcinoma and Efficacy, run by Sun Yat-sen University at 1 site in China.

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 8 inclusion and 14 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: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival rate (time frame: 1 year). 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 NCT06281886, which also lists 15 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 3 Aug 2026.

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