Status:
RECRUITING
Conversion Therapy With RC48, Sintilimab, and SOX for HER2 1+/2+ Unresectable Gastric Cancer
Lead Sponsor:
Fudan University
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This study aims to evaluate the efficacy of disitamab vedotin in combination with sintilimab and SOX as conversion therapy in patients with initially unresectable locally advanced or metastatic gastri...
Detailed Description
This is an open-label, single-arm, exploratory study designed to enroll patients with a single initial unresectable factor and HER2 IHC 1+/2+ locally advanced or metastatic gastric cancer. The primary...
Eligibility Criteria
Inclusion
- Voluntarily enrolled and provided written informed consent;
- Aged 18-70 years (inclusive), male or female;
- Histologically and/or cytologically confirmed unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma;
- No prior systemic anticancer therapy;
- HER2 immunohistochemistry (IHC) result of 2+ or 1+, based on either previous test results (confirmed by the investigator) or central laboratory assessment;
- Presence of a single initial unresectable factor;
- At least one measurable lesion per RECIST 1.1;
- Life expectancy ≥ 6 months;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
- Adequate organ function, defined as follows:
- Hematological (within 14 days prior to screening, without transfusion or granulocyte colony-stimulating factor \[G-CSF\] support):
- Hemoglobin ≥ 90 g/L;
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L;
- White blood cell count ≥ 3.0 × 10⁹/L;
- Platelet count ≥ 80 × 10⁹/L;
- Biochemical (within 14 days prior to screening, without albumin infusion):
- Albumin ≥ 28 g/L;
- Total bilirubin ≤ 2 × upper limit of normal (ULN);
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 × ULN in the absence of liver metastases; or ≤ 5 × ULN if liver metastases are present;
- Serum creatinine ≤ 1.5 × ULN; or creatinine clearance (CrCl) ≥ 50 mL/min as calculated by the Cockcroft-Gault formula;
- Coagulation:
- International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN;
- Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
Exclusion
- History of malignancies other than gastric cancer, with the following exceptions:
- Malignancies treated with curative intent and with no evidence of disease for 5 years;
- Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, or other in situ carcinomas.
- Conditions affecting the absorption, distribution, metabolism, or excretion of the investigational drug(s) (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, malabsorption, etc.).
- Previous allogeneic stem cell or solid organ transplantation.
- Prior systemic antitumor therapy (including Chinese herbal medicine with antitumor indications) completed less than 4 weeks before the first dose of study treatment, or with prior treatment-related adverse events not recovered to ≤ CTCAE grade 1 (except for alopecia or pigmentation).
- History or presence of congenital or acquired immunodeficiency disorders.
- Active or previously documented autoimmune or inflammatory disorders (including but not limited to autoimmune hepatitis, interstitial pneumonia, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, uveitis, hypophysitis, hyperthyroidism, hypothyroidism, asthma requiring bronchodilators, etc.). Patients with vitiligo, childhood asthma that has fully resolved without intervention in adulthood, or other conditions deemed eligible by the investigator may be included.
- Use of systemic immunosuppressive therapy within 2 weeks prior to enrollment, or anticipated need for such therapy during the study, with the following exceptions:
- Intranasal, inhaled, topical, or local corticosteroid injections (e.g., intra-articular);
- Systemic corticosteroids at a dose ≤ 10 mg/day prednisone or equivalent;
- Prophylactic corticosteroids for hypersensitivity reactions.
- Known or suspected history of hypersensitivity to disitamab vedotin, anti-PD-1 agents, chimeric or humanized antibodies or fusion proteins, or any excipient of the investigational drug(s).
- History of thrombotic or thromboembolic events within the past 6 months, such as stroke and/or transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc.
- Patients assessed by the physician to be at significant risk of bleeding, including but not limited to:
- Major bleeding (\>30 mL within 3 months) or hemoptysis (\>5 mL within 4 weeks); endoscopic evaluation may be performed to confirm eligibility;
- Active bleeding or coagulation disorders;
- Bleeding tendency or current use of thrombolytic, anticoagulant, or antiplatelet therapy.
Key Trial Info
Start Date :
September 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07194005
Start Date
September 4 2025
End Date
September 30 2028
Last Update
September 26 2025
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200230