Actively Recruiting
XELOX Combined With Sintilimab and HBO for Advanced or Metastatic GC/GEJC
Led by West China Hospital · Updated on 2025-05-07
57
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
XELOX Combined With Sintilimab and HBO for Advanced or Metastatic GC/GEJC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
- Presence of metastatic disease confirmed by radiologic or surgical assessment
- Life expectancy predicted to be more than 3 months
- Age between 18 and 75 years
- No prior antitumor treatments; if prior adjuvant/neoadjuvant therapy given, completed at least 6 months before with no recurrence
- Palliative radiotherapy allowed if completed at least 2 weeks before treatment
- Prior anti-tumor traditional Chinese medicine allowed if stopped at least 2 weeks before randomization
- ECOG performance status of 0 or 1
- At least one measurable lesion according to RECIST 1.1 criteria
- Archived or fresh pathological tissue available within 6 months for PD-L1 testing
- Adequate organ function including specified blood counts and biochemistry levels
- No systemic treatment within 6 months after sample collection for randomization
- Prior treatment toxicities resolved to grade 0-1 or as specified
- Willingness to use strict contraception
- Signed informed consent and ability to comply with study procedures
You will not qualify if you...
- HER2-positive status (HER2 3+ or 2+ with FISH positive)
- Non-adenocarcinoma gastric cancers such as squamous cell carcinoma or undifferentiated carcinoma
- Uncontrolled or symptomatic active central nervous system metastases
- Uncontrolled pleural effusion or ascites requiring recent drainage; moderate to large pericardial effusion
- Weight loss greater than 20% within 2 months before randomization
- Major surgery within 28 days before randomization (except diagnostic biopsies and PICC placement)
- Use of immunosuppressive drugs within 7 days before randomization except low-dose steroids
- Live attenuated vaccines within 28 days before randomization or during study or within 60 days after
- Antitumor treatments within 28 days before randomization
- Other malignancies within 3 years except certain localized and cured cancers
- Active autoimmune diseases requiring systemic immunosuppression
- Uncontrolled epilepsy, congenital spherocytosis, claustrophobia, or angle-closure glaucoma
- Prior treatment with anti-PD-1/PD-L1, anti-CTLA-4, or other checkpoint inhibitors
- Significant bleeding or thrombotic events within specified timeframes
- Major vascular disease within 6 months before treatment
- Severe unhealed wounds, active ulcers, or untreated fractures
- Peripheral neuropathy greater than Grade 1
- History of intestinal obstruction or related symptoms within 6 months
- Uncontrolled systemic diseases such as diabetes, hypertension, pulmonary fibrosis, or acute pneumonia
- Known severe allergies to study drugs or monoclonal antibodies
- HIV infection or known AIDS
- Untreated active hepatitis B or C or coinfection
- Recent serious cardiac conditions or poorly controlled hypertension
- Recent systemic antibiotic use or unexplained fever during screening
- History of organ or stem cell transplantation
- Participation in another drug clinical trial within 4 weeks before randomization
- History of psychiatric drug abuse or drug addiction
- Other serious illnesses or abnormal lab tests posing risk or interference
- Severe pulmonary conditions such as treated pneumothorax, severe emphysema, or pulmonary bullae
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
2
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
Research Team
M
Ming Liu, M.D
CONTACT
C
Cheng Huang, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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