PD-1 Antibody Combined With mXELIRI Versus mXELIRI in the Second-line Setting for ESCC
Status:
Not yet recruiting
Trial end date:
2026-02-17
Target enrollment:
Participant gender:
Summary
This trial is a prospective, multicenter, randomized controlled trial. The sample size was
380. Patients with advanced or metastatic esophageal squamous cell carcinoma will be
randomized to receive PD1 antibody combined with mXELIRI or mXELIRI regimens in a 1:1 ratio.
The stratification factors include PS status (0 vs 1), PFS of first-line treatment (PFS < 3
months versus PFS ≥3 months) . Six cycles of chemotherapy are planned every 3 weeks, for a
total of 18 weeks, after which the investigator can decide whether to provide capecitabine
with or without PD1 antibody maintenance therapy. Efficacy assessments were performed every 6
weeks before disease progression during treatment. Survival status was followed every 3
months after disease progression.
Phase:
Phase 3
Details
Lead Sponsor:
Sun Yat-sen University
Collaborators:
Jiangsu HengRui Medicine Co., Ltd. Shanghai Junshi Bioscience Co., Ltd.