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

NCT ID: NCT06281886

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2026-12-01

Brief 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

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.

Conditions

Esophageal Squamous Cell Carcinoma; Efficacy; Toxicity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

The study group

Patients are planned to receive 2 cycles of induction immuno-chemotherapy plus apatinib, followed by concurrent chemoradiotherapy plus apatinib.

Group Type: EXPERIMENTAL

Induction Immunotherapy-Toripalimab

Intervention Type: DRUG

Toripalimab 240mg iv. drip, Q3W, 2 cycles

Induction Chemotherapy-Albumin-paclitaxel combined with cisplatin

Intervention Type: DRUG

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

Radiotherapy

Intervention Type: RADIATION

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

Apatinib

Intervention Type: DRUG

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

Capecitabine

Intervention Type: DRUG

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

The control group

Patients are planned to receive 2 cycles of induction immuno-chemotherapy, followed by concurrent chemoradiotherapy.

Group Type: ACTIVE_COMPARATOR

Induction Immunotherapy-Toripalimab

Intervention Type: DRUG

Toripalimab 240mg iv. drip, Q3W, 2 cycles

Induction Chemotherapy-Albumin-paclitaxel combined with cisplatin

Intervention Type: DRUG

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

Radiotherapy

Intervention Type: RADIATION

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

Capecitabine

Intervention Type: DRUG

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

Interventions

Induction Immunotherapy-Toripalimab

Toripalimab 240mg iv. drip, Q3W, 2 cycles

Intervention Type: 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.

Intervention Type: DRUG

Radiotherapy

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

Intervention Type: RADIATION

Apatinib

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

Intervention Type: DRUG

Capecitabine

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

Intervention Type: DRUG

Other Intervention Names

Chemotherapy concurrently with radiotherapy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Hui Liu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hui Liu, Professor

Role: PRINCIPAL_INVESTIGATOR

Sun yat-sen universtiy cancer center

Locations

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

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Other Identifiers

GASTO-10107

Identifier Type: -

Identifier Source: org_study_id