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

NCT06881017 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-03-18

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Trastuzumab

iv,d1

DRUG

Adebrelimab

iv,d1,q3w

DRUG

Apatinib

po,qd,d1-21,q3w

DRUG

S-1

po,bid,d1-14,q3w

DRUG

Capecitabine

po,bid,d1-14

DRUG

Oxaliplatin

iv,d1,q3w

DRUG

zolbetuximab

iv,d1

DRUG

SHR-A1811

iv,d1 ,q3w

DRUG

SHR-A1904

iv,d1 ,q3w

DRUG

SHR-1701

iv,d1 ,q3w

Sponsors & Collaborators

  • China Medical University, China

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2029-08-01
Completion
2029-11-01

More Related Trials

Entities

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 NCT06881017 on ClinicalTrials.gov