PD-1 Antibody Combined With mXELIRI Versus mXELIRI in the Second-line Setting for ESCC
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.
Timeline
- Start
- 2023-02-17
- Primary completion
- 2026-02-17
- Completion
- 2026-02-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Camrelizumab | Monoclonal antibody | 200 mg | Other |
| Subject | Teripulimab | Unknown | 240 mg | Other |
| Background | Capecitabine | Small molecule | 1600 mg/m2 | Oral |
| Background | Irinotecan | Small molecule | 150 mg/m2 | Other |
| Background | Irinotecan | Small molecule | 200 mg/m2 | Other |