NCT06881017

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

Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping: an Umbrella Phase II Exploratory Clinical Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: China Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2025-05-01
• Primary completion: 2029-08-01
• Completion: 2029-11-01
• First posted: 2025-03-18
• Last updated: 2025-03-18