XELOX Combined With Sintilimab and HBO for Advanced or Metastatic GC/GEJC
ConditionGastric (Stomach) Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWest China Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
HER2 status: HER2-positive (HER2 3+ or 2+ & FISH+).
Tumor type: Nonadenocarcinoma gastric cancers, including squamous cell carcinoma, undifferentiated carcinoma, or mixed histological types.
CNS Metastasis: Uncontrolled or symptomatic active CNS metastasis (e.g., clinical symptoms, brain edema, spinal cord compression, carcinomatous meningitis, soft meningeal disease, or progressive growth).
Fluid accumulation: Uncontrolled pleural effusion or ascites treated with drainage within 14 days before randomization; symptomatic or moderate to large pericardial effusion.
Trial design
Treatments tested in this trial
- XELOX+Sintilimab+HBOT
Treatment groups
57 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov