PD-1 Antibody Combined With mXELIRI Versus mXELIRI in the Second-line Setting for ESCC

Conditions

• Esophageal Squamous Cell Carcinoma Abdominal Stage 0

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PD-1 Inhibitors — DRUG
  Teripulimab 240mg, injection or Carrelizumab 200mg, injection, every 3 weeks.
• Irinotecan — DRUG
  Irinotecan: 200mg/m2, injection (For patients who are confirmed to be homozygous for UGT1A1\*6 or UGT1A1\*28 or UGT1A1\*6 and UGT1A1\*28 at the same time, the starting dose of CPT-11 is 150 mg/m2).
• Capecitabine tablets — DRUG
  Capecitabine: 1600 mg/m2/d, oral, 2 weeks on and 1 week off.

Study Details

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.

Key Dates

Start date

Feb 17, 2023

Status verified

Jan 2024

Primary completion

Feb 17, 2026

Completion

Feb 17, 2026

Study Design

Enrollment

380 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Experimental
  PD-1 Antibody Combined With mXELIRI
• Active Comparator: Control
  mXELIRI

Primary Outcome Measure

Overall survival (OS) [ Time Frame: Up to 1 year ]