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.
Age ≥18 years, regardless of gender;
Histologically or pathologically confirmed gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction;
Advanced or metastatic disease with no prior systemic therapy for advanced-stage disease (Patients who relapsed >6 months after completing neoadjuvant/adjuvant therapy are eligible, with prior neoadjuvant/adjuvant regimens not counted as prior lines of therapy);
At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST v1.1);
History of gastrointestinal perforation and/or fistula within 6 months prior to treatment, or active gastrointestinal bleeding within 3 months;
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage;
Known history of hypersensitivity to any component of the investigational drug(s) or excipients;
Received any investigational drug within 4 weeks prior to the first dose of the study drug or within 5 half-lives of the last investigational agent (whichever is shorter);
Parallel
Trastuzumab
Drugiv，d1
Adebrelimab
Drugiv，d1，q3w
Apatinib
Drugpo，qd，d1-21，q3w
S-1
Drugpo，bid，d1-14，q3w
Capecitabine
Drugpo，bid，d1-14
Oxaliplatin
Drugiv，d1，q3w
zolbetuximab
Drugiv，d1
SHR-A1811
Drugiv，d1 ，q3w
SHR-A1904
Drugiv，d1 ，q3w
SHR-1701
Drugiv，d1 ，q3w
7
Treatment groupsSee each treatment group below.
ORR
Objective Response Rate (ORR) is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) to a therapeutic intervention, as assessed by standardized criteria (e.g., RECIST 1.1 for solid tumors). It serves as a key efficacy endpoint in early-phase clinical trials to evaluate the preliminary antitumor activity of investigational therapies.
OS
Overall Survival (OS) is defined as the time from randomization (or initiation of treatment) until death from any cause. It is considered the gold standard endpoint in oncology clinical trials due to its objectivity and direct relevance to patient benefit.
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This trial is not recruiting at the moment. You can still explore other options:
