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
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
-
iv,d1
- DRUG
-
Adebrelimab
iv,d1,q3w
- DRUG
-
Apatinib
po,qd,d1-21,q3w
- DRUG
-
S-1
po,bid,d1-14,q3w
- DRUG
-
po,bid,d1-14
- DRUG
-
iv,d1,q3w
- DRUG
-
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
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