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

NCT05737563 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2024-01-23

No results posted yet for this study

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.

Conditions

  • Esophageal Squamous Cell Carcinoma Abdominal Stage 0

Interventions

DRUG

PD-1 Inhibitors

Teripulimab 240mg, injection or Carrelizumab 200mg, injection, every 3 weeks.

DRUG

Irinotecan

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).

DRUG

Capecitabine tablets

Capecitabine: 1600 mg/m2/d, oral, 2 weeks on and 1 week off.

Sponsors & Collaborators

  • Shanghai Junshi Bioscience Co., Ltd.

    collaborator OTHER

  • Jiangsu HengRui Medicine Co., Ltd.

    collaborator INDUSTRY

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-17
Primary Completion
2026-02-17
Completion
2026-02-17

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05737563 on ClinicalTrials.gov