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BC001 in Combination with Sintilimab and XELOX in the Treatment of HER-2 Negative Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma.

NCT06773312 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-03-10

No results posted yet for this study

Summary

The goal of this clinical trial is to learn the efficaty and safety of BC001 in combination with Sintilimab and XELOX in treating patients with advanced or metastatic GC/GEJ.

Participants will:

Be administered with BC001, Sintilimab and Oxaliplatin once every three weeks for up to 24 months or until disease progression as per RECIST 1.1 or withdrawal from this study.

Take Capecitabine once daily in the first two weeks of each three-week treatment cycle for up to 24 months or until disease progression as per RECIST 1.1 or withdrawal from this study.

Conditions

  • Advanced or Metastatic Gastric Cancer
  • Gastroesophageal Junction Adenocarcinoma

Interventions

BIOLOGICAL

BC001+Sintilimab+XELOX

patients will be given : BC001 8mg/kg, 12mg/kg or 16mg/kg intravenously once every three weeks; Sintilimab 3mg/kg（body weight\<60kg）or 200mg（body weight≥60kg）intravenously once every three weeks; Oxaliplatin 130mg/m2 intravenously once every three weeks; Capecitabine 1000mg/m2 orally once daily in the first two weeks of each three-week treatment cycle.

Sponsors & Collaborators

  • Peking University Cancer Hospital & Institute

    collaborator OTHER

  • Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-28
Primary Completion
2026-10-31
Completion
2027-04-30

Countries

  • China

Study Locations

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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 NCT06773312 on ClinicalTrials.gov