BridgeMD
New treatment option for Gastric (Stomach) Cancer
Official title XELOX Combined With Sintilimab and HBO for Advanced or Metastatic GC/GEJC
ClinicalTrials.gov ID: NCT06742411
What this study is testing
What is XELOX+Sintilimab+HBOT?
XELOX+Sintilimab+HBOT is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for gastric (stomach) cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 1.Diagnosis: Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (including signet ring cell...
- There are no previous antitumor treatments (chemotherapy, radiotherapy, targeted therapy, immunotherapy, treatment therapy, etc.).
- If patients previously received adjuvant or neoadjuvant therapy, the last treatment must have been completed at least 6 months before randomization...
- 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. 6.Performance...
You likely can't join if
- . 12.Contraception: Strict contraception measures. 13.Consent and Compliance: Signed informed consent, willing and able to comply with study visits...
- 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...
- Fluid accumulation: Uncontrolled pleural effusion or ascites treated with drainage within 14 days before randomization; symptomatic or moderate to...
- Weight loss: Weight loss \>20% within 2 months before randomization.
See the full eligibility criteria
- 1.Diagnosis: Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (including signet ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma). 2.Disease...
- There are no previous antitumor treatments (chemotherapy, radiotherapy, targeted therapy, immunotherapy, treatment 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. 6.Performance Status: ECOG PS ≤1. 7.Assessable lesion: At least one measurable lesion per...
- 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 levels were ≤3×ULN (≤5×ULN if liver metastasis was present). creatinine ≤1.5×ULN. (3)Coagulation: INR...
- . 12.Contraception: Strict contraception measures. 13.Consent and Compliance: Signed informed consent, willing and able to comply with study visits, treatments, lab tests, and procedures. Exclusion criteria:
- 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.
- Weight loss: Weight loss \>20% within 2 months before randomization.
- Recent treatments: (1)Major surgery within 28 days before randomization (diagnostic biopsies and PICC placement allowed). (2)Immunosuppressive drugs should be used within 7 days before randomization, excluding...
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.