Clinical Research Directory
Browse clinical research sites, groups, and studies.
Induction Chemo-Immunotherapy + Radiotherapy vs Concurrent Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
Sponsor: Second Affiliated Hospital of Zunyi Medical University
Summary
This is a prospective, randomized, phase II clinical study in patients with unresectable stage III-IVA esophageal squamous cell carcinoma (ESCC). Eligible patients will be randomly assigned in a 1:1 ratio to two treatment groups. The experimental group will receive 3 cycles of induction therapy with PD-1 antibody plus chemotherapy, followed by radiotherapy, and then maintenance therapy with PD-1 antibody monotherapy. The control group will receive concurrent chemoradiotherapy, followed by maintenance therapy with PD-1 antibody monotherapy. The primary endpoints are the complete response (CR) rate at 3 months after radiotherapy (assessed by investigators) and the 1-year progression-free survival (PFS) rate. Secondary endpoints include overall survival (OS), progression-free survival (PFS), duration of response, objective response rate (ORR), local-regional recurrence-free survival (LRFS), distant metastasis-free survival (DMFS), quality of life, and safety profile.
Official title: Efficacy and Safety of Induction Chemo-Immunotherapy Followed by Radiotherapy vs Concurrent Chemoradiotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: A Randomized, Two-Arm, Phase II Study
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
92
Start Date
2026-01-01
Completion Date
2028-06-30
Last Updated
2026-04-30
Healthy Volunteers
No
Interventions
Paclitaxel plus Cisplatin or Carboplatin (Induction Chemotherapy)
Paclitaxel 150-175 mg/m² combined with cisplatin 75 mg/m² or carboplatin AUC 5 (maximum 600 mg), administered intravenously every 3 weeks for 3 cycles, concurrent with PD-1 antibody induction therapy for unresectable stage III-IVA esophageal squamous cell carcinoma.
Weekly Paclitaxel plus Cisplatin or Carboplatin (Concurrent Chemotherapy)
Paclitaxel 50 mg/m² combined with cisplatin 25 mg/m² or carboplatin AUC 5 (maximum 600 mg), administered intravenously once weekly for 5 cycles, concurrent with thoracic radiotherapy (50.4Gy in 28 fractions) for unresectable stage III-IVA esophageal squamous cell carcinoma.
Locations (1)
The Second Affiliated Hospital of Zunyi Medical University, Xinpu New District, Honghuagang District, Zunyi City, Guizhou Province
Zunyi, Guizhou, China