OncoMatch/Clinical Trials/NCT06773312
BC001 in Combination with Sintilimab and XELOX in the Treatment of HER-2 Negative Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma.
Is NCT06773312 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies BC001+Sintilimab+XELOX for advanced or metastatic gastric cancer.
Treatment: BC001+Sintilimab+XELOX — The goal of this clinical trial is to learn the efficaty and safety of BC001 in combination with Sintilimab and XELOX in treating patients with advanced or metastatic GC/GEJ. Participants will: Be administered with BC001, Sintilimab and Oxaliplatin once every three weeks for up to 24 months or until disease progression as per RECIST 1.1 or withdrawal from this study. Take Capecitabine once daily in the first two weeks of each three-week treatment cycle for up to 24 months or until disease progression as per RECIST 1.1 or withdrawal from this study.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Esophageal Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative
HER-2 negative patients
Excluded: DPYD deficiency
Subjects known to have dihydropyrimidine dehydrogenase (DPD) deficiency (or those who have experienced grade 3 or above mucosal toxicity during previous fluorouracil-containing treatments)
Disease stage
Metastatic disease required
advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ) (according to the 8th edition of AJCC/UICC TNM staging)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Lab requirements
Blood counts
ANC ≥1.5×10⁹/L, platelet (PLT) ≥100×10⁹/L, hemoglobin (HGB) ≥90g/L
Kidney function
Serum creatinine (Cr) ≤1.5×ULN. When Cr > 1.5×ULN, creatinine clearance rate (Ccr) ≥ 60mL/min; qualitative urine protein ≤1+, or if ≥2+, 24-hour urine protein < 1g
Liver function
total bilirubin (TBIL) ≤1.5×ULN or ≤3×ULN (for patients with liver cancer or liver metastases), alanine aminotransferase (AST) and aspartate aminotransferase (ALT) ≤3.0×ULN or ≤5×ULN (for patients with liver cancer or liver metastases), alkaline phosphatase (ALP) ≤2.5×ULN or ≤5×ULN (for patients with liver cancer or liver metastases)
Cardiac function
INR or prothrombin time (PT) ≤1.5×ULN, activated partial thromboplastin time (APTT) ≤1.5×ULN
no serious hematological, hepatic or renal function abnormality, meeting the following laboratory test results: the absolute neutrophil count (ANC) should be ≥1.5×10⁹/L, platelet (PLT) ≥100×10⁹/L, and hemoglobin (HGB) ≥90g/L; Serum creatinine (Cr) ≤1.5× the upper limit of normal range (ULN). When Cr > 1.5×ULN, , and creatinine clearance rate (Ccr)≥ 60mL/min(calculated according to the Cockcroft - Gault formula); the qualitative urine protein should be ≤1 +, or if the qualitative urine protein ≥2 +, the 24-hour urine protein < 1g; total bilirubin (TBIL) ≤1.5×ULN or ≤3×ULN (for patients with liver cancer or liver metastases), alanine aminotransferase (AST) and aspartate aminotransferase (ALT) ≤3.0×ULN or ≤5×ULN (for patients with liver cancer or liver metastases), alkaline phosphatase (ALP) ≤2.5×ULN or ≤5×ULN (for patients with liver cancer or liver metastases); the international normalized ratio (INR) or prothrombin time T (PT) ≤1.5×ULN, and the activated partial thromboplastin time (APTT) ≤1.5×ULN.
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