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

NCT06281886 | Active Not Recruiting Phase 2

• 1 other identifier: GASTO-10107
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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

Conditions

Esophageal Squamous Cell Carcinoma; Efficacy; Toxicity

Keywords

Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma; Induction immuno-chemotherapy; Concurrent chemoradiotherapy; Apatinib; Survival outcomes; Toxicity

Outcome Measures

Primary Outcomes (1)

• Progression free survival rate

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

  1 year

Secondary Outcomes (6)

• Overall survival

  1 year

• Objective response rate

  1 year

• Local-regional progression-free survival

  1 year

• Incidence of Treatment-related Adverse Events

  1 year

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

  1 year

Study Arms (2)

The study group

EXPERIMENTAL

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

Drug: Induction Immunotherapy-Toripalimab; Drug: Induction Chemotherapy-Albumin-paclitaxel combined with cisplatin; Radiation: Radiotherapy; Drug: Apatinib; Drug: Capecitabine

The control group

ACTIVE COMPARATOR

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

Drug: Induction Immunotherapy-Toripalimab; Drug: Induction Chemotherapy-Albumin-paclitaxel combined with cisplatin; Radiation: Radiotherapy; Drug: Capecitabine

Interventions

Induction Immunotherapy-Toripalimab DRUG

Toripalimab 240mg iv. drip, Q3W, 2 cycles

The control group; The study group

Induction Chemotherapy-Albumin-paclitaxel combined with cisplatin DRUG

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

The control group; The study group

Radiotherapy RADIATION

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

The control group; The study group

Apatinib DRUG

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

The study group

Capecitabine DRUG

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

Also known as: Chemotherapy concurrently with radiotherapy

The control group; The study group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (15)

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MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Cisplatin; Radiotherapy; apatinib; Capecitabine

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Hui Liu, Professor

  Sun yat-sen universtiy cancer center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 28, 2024
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

CN (1)