NCT06281886

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-12-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-02-28
• Last updated: 2025-11-17

Locations

1 site across 1 country: China