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

July 31, 2026 updated by: Hui Liu, Sun Yat-sen University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The study group
Patients are planned to receive 2 cycles of induction immuno-chemotherapy plus apatinib, followed by concurrent chemoradiotherapy plus apatinib.
Drug: Induction Immunotherapy-Toripalimab
Toripalimab 240mg iv. drip, Q3W, 2 cycles
Drug: Induction Chemotherapy-Albumin-paclitaxel combined with cisplatin
Albumin-paclitaxel 260 mg/m2, administered on day 1, combined with cisplatin 25 mg/m2, administered on day 1,2,3.
Radiation: Radiotherapy
Thoracic radiotherapy at a total dose of 50Gy was delivered using the intensity modulated radiation therapy technique.
Drug: Apatinib
Oral apatinib 250mg once daily during induction therapy and concurrent chemoradiotherapy.
Drug: Capecitabine
Oral capecitabine 1000 mg/m2, twice daily, on days 1-14, every 3 weeks, concurrently with radiotherapy
Other Names:
  • Chemotherapy concurrently with radiotherapy
Active Comparator: The control group
Patients are planned to receive 2 cycles of induction immuno-chemotherapy, followed by concurrent chemoradiotherapy.
Drug: Induction Immunotherapy-Toripalimab
Toripalimab 240mg iv. drip, Q3W, 2 cycles
Drug: Induction Chemotherapy-Albumin-paclitaxel combined with cisplatin
Albumin-paclitaxel 260 mg/m2, administered on day 1, combined with cisplatin 25 mg/m2, administered on day 1,2,3.
Radiation: Radiotherapy
Thoracic radiotherapy at a total dose of 50Gy was delivered using the intensity modulated radiation therapy technique.
Drug: Capecitabine
Oral capecitabine 1000 mg/m2, twice daily, on days 1-14, every 3 weeks, concurrently with radiotherapy
Other Names:
  • Chemotherapy concurrently with radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival rate
Time Frame: 1 year
From the first day of treatment to the day of progression or the day of death.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 1 year
It was calculated from the first day of treatment to the day of death.
1 year
Objective response rate
Time Frame: 1 year
The proportion of patients evaluated as CR or PR
1 year
Local-regional progression-free survival
Time Frame: 1 year
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.
1 year
Incidence of Treatment-related Adverse Events
Time Frame: 1 year
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.
1 year
Score of Quality of Life Questionnare-Core 30 (The European Organization for Reasearch and Treatment of Cancer)
Time Frame: 1 year
The evaluation of life quality
1 year
Distant metastasis-free survival
Time Frame: 1 year
Distant metastasis-free survival refers to the period from the initiation of treatment until the appearance of metastasis in distant organs or tissues.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Hui Liu, Professor, Sun yat-sen universtiy cancer center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2024

Primary Completion (Actual)

June 25, 2026

Study Completion (Actual)

June 25, 2026

Study Registration Dates

First Submitted

February 13, 2024

First Submitted That Met QC Criteria

February 20, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

August 3, 2026

Last Update Submitted That Met QC Criteria

July 31, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GASTO-10107

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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