NCT07246330

Stratified Treatment in Unresectable Locally Advanced ESCC Without Progression After Chemoimmunotherapy Induction Plus CCRT: Toripalimab Consolidation vs observation--a Prospective, Randomized, Controlled Phase III Multicenter Study

Stratified Treatment in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma Without Progression After Chemoimmunotherapy Induction Plus Concurrent Chemoradiotherapy: Toripalimab Consolidation vs observation--a Prospective, Randomized, Controlled Phase III Multicenter Study

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 340 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, randomized controlled, phase III multicenter trial. Its objectives are to explore the stratified application of consolidation immunotherapy after chemoimmunotherapy induction plus concurrent chemoradiotherapy, identify the potential beneficiary population of consolidation immunotherapy, and evaluate the efficacy and safety of consolidation immunotherapy. The main participants are patients with unresectable locally advanced esophageal squamous cell carcinoma who have undergone 2-4 cycles of chemoimmunotherapy induction followed by concurrent chemoradiotherapy. Imaging assessment should be completed within 1-84 days after the end of chemoradiotherapy. Eligible patients meeting the inclusion and exclusion criteria will be divided into the CR/PR cohort and SD cohort based on treatment response, and receive the following treatments respectively: CR/PR cohort: Patients with a response assessment of CR (Complete Response) or PR (Partial Response) will be randomly assigned at a 1:1 ratio to: Toripalimab monotherapy maintenance group (Group A1) vs. Observation group (Group A2) (116 patients vs. 116 patients) SD cohort: Patients with a response assessment of SD (Stable Disease) will be randomly assigned at a 1:1 ratio to: Toripalimab monotherapy maintenance group (Group B1) vs. Observation group (Group B2) (54 patients vs. 54 patients) The medication dosage is as follows: Toripalimab 240mg, intravenous infusion on Day 1, every 3 weeks (Q3W). A total of 3 treatment cycles will be administered. Subsequent treatment continuation will be determined by the patient. If continued, treatment will proceed until the occurrence of disease progression (radiological progression confirmed by RECIST v1.1), intolerable toxicity, initiation of new antitumor therapy, voluntary withdrawal of the subject from the study, or the investigator's judgment that the subject needs to withdraw. The maximum duration of medication is 1 year.

Conditions

• Esophageal Squamous Cell Carcinoma (ESCC)

Interventions

Type	Name	Description
DRUG	Toripalimab	Toripalimab 240 mg, administered on the first day of each cycle, and a cycle of administration every 3 weeks

Timeline

• Start date: 2025-12-15
• Primary completion: 2027-12-15
• Completion: 2029-12-15
• First posted: 2025-11-24
• Last updated: 2025-11-24