Status:
NOT_YET_RECRUITING
Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping
Lead Sponsor:
China Medical University, China
Conditions:
Gastric Cancer
HER2 + Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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:
- Hemoglobin ≥90 g/L (no blood transfusion within 14 days);
- Absolute neutrophil count (ANC) ≥1.5×10⁹/L;
- Platelet count ≥90×10⁹/L;
- Total bilirubin ≤1.5×upper limit of normal (ULN);
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (≤5×ULN if liver metastases are present);
- Serum creatinine ≤1.5×ULN;
- Left ventricular ejection fraction (LVEF) ≥50% by echocardiography; QTc interval \<450 ms for males and \<470 ms for females;
- Coagulation parameters:
- For patients not on anticoagulation therapy: INR ≤1.5 and activated partial thromboplastin time (APTT) ≤1.5×ULN;
- For patients receiving full-dose or parenteral anticoagulation: Stable anticoagulant dose for ≥2 weeks prior to enrollment, with coagulation tests within the therapeutic range;
- Contraception requirements:
- Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and agree to use effective contraception during the study and for 3 months after the last dose;
- Men must be surgically sterile or agree to use effective contraception during the study and for 3 months after the last dose;
- Recovery from prior therapy-related toxicities to ≤Grade 1 (surgical wounds must be fully healed if applicable);
- Voluntary participation with signed informed consent form and anticipated adherence to protocol requirements.
Exclusion
- 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;
- 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;
- Severe infection (CTCAE v5.0 Grade \>2) within 4 weeks prior to the first dose of the study drug (e.g., pneumonia requiring hospitalization, bacteremia, or septic complications); active pulmonary inflammation on baseline chest imaging, or signs/symptoms of infection requiring oral/IV antibiotics within 2 weeks prior to the first dose (prophylactic antibiotics excluded);
- History of interstitial lung disease (except radiation pneumonitis without steroid treatment or non-infectious pneumonitis);
- Active tuberculosis (TB) infection confirmed by medical history or CT scan, history of active TB within 1 year prior to enrollment, or untreated active TB diagnosed \>1 year prior to enrollment;
- Diagnosis of another malignancy within 5 years prior to the first dose of the study drug, except malignancies with low metastatic/lethal risk (5-year survival rate \>90%), such as adequately treated basal cell carcinoma, squamous cell skin cancer, or carcinoma in situ of the cervix;
- Pregnant or lactating women;
- Other conditions deemed by the investigator to jeopardize subject safety or trial integrity, including severe comorbidities (e.g., psychiatric disorders), clinically significant laboratory abnormalities, or social/family factors that may compromise protocol adherence or data collection.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2029
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06881017
Start Date
May 1 2025
End Date
November 1 2029
Last Update
March 18 2025
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