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ACTIVE NOT RECRUITING
NCT06281886
PHASE2

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

170

Start Date

2023-12-01

Completion Date

2026-12-01

Last Updated

2025-11-17

Healthy Volunteers

No

Interventions

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

Locations (1)

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, China