Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping

Sponsor
China Medical University, China
Study ID
NCT06881017
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction
  • Gastric Cancer
  • HER2 + Gastric Cancer
  • PD-L1 Positive

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab — DRUG
    iv，d1
  • Adebrelimab — DRUG
    iv，d1，q3w
  • Apatinib — DRUG
    po，qd，d1-21，q3w
  • S-1 — DRUG
    po，bid，d1-14，q3w
  • Capecitabine — DRUG
    po，bid，d1-14
  • Oxaliplatin — DRUG
    iv，d1，q3w
  • zolbetuximab — DRUG
    iv，d1
  • SHR-A1811 — DRUG
    iv，d1 ，q3w
  • SHR-A1904 — DRUG
    iv，d1 ，q3w
  • SHR-1701 — DRUG
    iv，d1 ，q3w

Study Details

This study is a prospective, umbrella-design, Phase II clinical trial. Eligible participants with advanced or metastatic gastric cancer who are treatment-naïve for advanced-stage systemic therapy will undergo biomarker profiling (HER2, CLDN18.2, and PD-L1) via next-generation sequencing (NGS) or immunohistochemistry (IHC). Participants will be stratified into distinct molecular subtypes and assigned subtype-specific therapeutic regimens. The primary objectives are to assess treatment efficacy (e.g., objective response rate) and safety profiles across molecularly defined cohorts.

Key Dates

Start date
May 1, 2025
Status verified
Mar 2025
Primary completion
Aug 1, 2029
Completion
Nov 1, 2029

Study Design

Enrollment
140 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    HER2(+)\&CLDN18.2(+)\&PD-L1(+)
  • Experimental: Cohort 2
    HER2(+)\&CLDN18.2(+)\&PD-L1(-)
  • Experimental: Cohort 3
    HER2(2+ or 3+)\&CLDN18.2(-)\&PD-L1(-)
  • Experimental: Cohort 4
    HER2(-)\&CLDN18.2(+)\&PD-L1(+)
  • Experimental: Cohort 5
    HER2(-)\&CLDN18.2(-)\&PD-L1(+)
  • Experimental: Cohort 6
    HER2(-)\&CLDN18.2(+)\&PD-L1(-)
  • Experimental: Cohort 7
    HER2(-)\&CLDN18.2(-)\&PD-L1(-)

Primary Outcome Measure

ORR [ Time Frame: 2year ]

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