OncoMatch/Clinical Trials/NCT06742411
XELOX Combined With Sintilimab and HBO for Advanced or Metastatic GC/GEJC
Is NCT06742411 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies XELOX+Sintilimab+HBOT for gastric (stomach) cancer.
Treatment: XELOX+Sintilimab+HBOT — This study investigates the efficacy and safety of XELOX chemotherapy combined with sintilimab and hyperbaric oxygen therapy (HBOT) as a first-line treatment for patients with Advanced or Metastatic gastric and gastroesophageal junction adenocarcinoma. The trial comprises two phases: a phase Ib study to determine the optimal HBOT regimen and assess safety and tolerability, followed by a phase II study to evaluate the overall response rate (ORR). Secondary outcomes include progression-free survival (PFS), disease control rate (DCR), 2-year disease-free survival (DFS), 2-year overall survival (OS), safety, and quality of life. This study aims to provide a novel approach for enhancing therapeutic efficacy and improving patient outcomes by leveraging HBOT to address tumor hypoxia and augment the effects of chemotherapy and immune checkpoint inhibitors.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: PD-L1 (CD274) expression (testing required; no eligibility threshold specified)
sufficient for PD-L1 testing with obtainable results
Excluded: HER2 (ERBB2) overexpression
HER2-positive (HER2 3+ or 2+ & FISH+)
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Exception: adjuvant or neoadjuvant therapy completed at least 6 months before randomization, with no recurrence or disease progression during treatment; palliative radiotherapy completed ≥2 weeks before first study treatment; prior anti-tumor traditional Chinese medicine discontinued ≥2 weeks before randomization
There are no previous antitumor treatments (chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, etc.). If patients previously received adjuvant or neoadjuvant therapy, the last treatment must have been completed at least 6 months before randomization, with no recurrence or disease progression during treatment. Palliative radiotherapy is allowed if it is completed at least 2 weeks before the first study treatment. The use of prior anti-tumor traditional Chinese medicine is allowed if it is discontinued at least 2 weeks before randomization.
Cannot have received: anti-PD-1 therapy
Prior treatment with anti-PD-1/PD-L1 antibodies, anti-CTLA-4 antibodies, or other T-cell costimulation/checkpoint pathway drugs.
Cannot have received: anti-PD-L1 therapy
Prior treatment with anti-PD-1/PD-L1 antibodies, anti-CTLA-4 antibodies, or other T-cell costimulation/checkpoint pathway drugs.
Cannot have received: anti-CTLA-4 therapy
Prior treatment with anti-PD-1/PD-L1 antibodies, anti-CTLA-4 antibodies, or other T-cell costimulation/checkpoint pathway drugs.
Lab requirements
Blood counts
Hemoglobin ≥90 g/L. ANC ≥1.5×10⁹/L. Platelet count ≥75×10⁹/L.
Kidney function
creatinine ≤1.5×ULN
Liver function
Total bilirubin ≤1.5×ULN. AST and ALT ≤3×ULN (≤5×ULN if liver metastasis present).
Hematology (no transfusion or G-CSF use within 14 days before screening): Hemoglobin ≥90 g/L. Absolute neutrophil count (ANC) ≥1.5×10⁹/L. Platelet count ≥75×10⁹/L. Biochemistry (no albumin use within 14 days before screening): Albumin ≥28 g/L. Total bilirubin ≤1.5×ULN. AST and ALT ≤3×ULN (≤5×ULN if liver metastasis present). creatinine ≤1.5×ULN. 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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