OncoMatch/Clinical Trials/NCT07194005
Conversion Therapy With RC48, Sintilimab, and SOX for HER2 1+/2+ Unresectable Gastric Cancer
Is NCT07194005 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Disitamab vedotin(RC48) and Sintilimab for gastric cancer.
Treatment: Disitamab vedotin(RC48) · Sintilimab · S-1 · Oxaliplatin — 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 gastric cancer exhibiting HER2 IHC 1+/2+ expression. The trial plans to enroll patients with a single initial unresectable factor and HER2 IHC 1+/2+ status. Participants will receive disitamab vedotin combined with sintilimab and SOX for 4 to 6 treatment cycles. Those who achieve successful conversion will undergo surgical resection, while patients with unsuccessful conversion will either continue the original regimen or switch to an alternative treatment at the investigator's discretion.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Biomarker criteria
Required: HER2 (ERBB2) IHC 2+ (IHC 2+)
HER2 immunohistochemistry (IHC) result of 2+ or 1+
Required: HER2 (ERBB2) IHC 1+ (IHC 1+)
HER2 immunohistochemistry (IHC) result of 2+ or 1+
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic anticancer therapy
No prior systemic anticancer therapy
Cannot have received: systemic antitumor therapy (including Chinese herbal medicine with antitumor indications)
Exception: 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)
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)
Lab requirements
Blood counts
Hemoglobin ≥ 90 g/L; ANC ≥ 1.5 × 10⁹/L; WBC ≥ 3.0 × 10⁹/L; Platelet count ≥ 80 × 10⁹/L
Kidney function
Serum creatinine ≤ 1.5 × ULN; or creatinine clearance (CrCl) ≥ 50 mL/min as calculated by the Cockcroft-Gault formula
Liver function
Total bilirubin ≤ 2 × ULN; AST, ALT, ALP ≤ 2.5 × ULN in the absence of liver metastases; or ≤ 5 × ULN if liver metastases are present
Adequate organ function, defined as follows: Hematological (within 14 days prior to screening, without transfusion or G-CSF support): Hemoglobin ≥ 90 g/L; ANC ≥ 1.5 × 10⁹/L; WBC ≥ 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 × ULN; AST, ALT, 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: INR or PT ≤ 1.5 × ULN; APTT ≤ 1.5 × ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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