Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel… (NCT06881017) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping
140 participantsStarted 2025-05-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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);
✓. Archival or fresh tumor tissue sample available for biomarker testing (HER2, CLDN18.2, and PD-L1 expression);
✓. ECOG performance status: 0-1;
✓. Life expectancy ≥12 weeks;
✓. Adequate organ and bone marrow function meeting the following criteria:
Exclusion criteria
✕. History of gastrointestinal perforation and/or fistula within 6 months prior to treatment, or active gastrointestinal bleeding within 3 months;
✕. Known history of hypersensitivity to any component of the investigational drug(s) or excipients;
✕. Prior treatments meeting any of the following:
✕. 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);
✕. Concurrent enrollment in another interventional clinical study (observational or follow-up studies are permitted);
✕. Received antitumor therapy (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologics, or tumor embolization) within 2 weeks prior to the first dose of the study drug;
✕. History of leptomeningeal metastasis or current active brain metastases;