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Tests treatment safety and results for Gastric Cancer
Official title A Clinical Study Evaluating the Efficacy of Systemic Chemotherapy and Immune Checkpoint Inhibitors Combined With Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Gastric Cancer Patients With Peritoneal Metastasis
ClinicalTrials.gov ID: NCT06685887
What this study is testing
What is HIPEC?
HIPEC is an investigational medicine, being studied as a potential treatment for gastric 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 is a single-center, prospective, phase II clinical trial aimed at assessing the impact of HIPEC combined with systemic chemotherapy and immune checkpoint inhibitors on the R0 resection rate in patients with peritoneal metastasis from gastric cancer. Furthermore, it seeks to analyze the effects of this treatment strategy on overall survival (OS), progression-free survival (PFS), PCI and adverse reaction rates.
- 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
- 18-75 years
- Men, or non-pregnant and non-lactating women
- Pathological diagnosis as gastric malignant tumor
- diagnosis of peritoneal metastasis [peritoneal cancer index (PCI) ≤ 12 points] by laparoscopic exploration
- Normal major organ function: 1) HB ≥ 90 g/L； ANC ≥ 1.5×109/L; plt ≥125×109/L; 2) TBIL\<1.5ULN; ALT, AST \<2.5ULN; Cr≤1.25ULN; ALB ≥ 30 g/L 6. Not...
You likely can't join if
- Patients have other malignant tumors within the past 5 years.
- Patients use immunosuppressant within 30 days prior to the initial use of tirelizumab, excluding nasal sprays and physiological doses of inhaled...
- Patients have a documented history of ongoing autoimmune conditions or prior autoimmune diseases.
- Patients are allergic to oxaliplatin, S-1, other related chemotherapy drugs or immune checkpoint inhibitors.
- Patients with epilepsy or other mental disorders.
- Patients who are unable to undergo surgery due to severe heart, lung and vascular diseases.
See the full eligibility criteria
- 18-75 years
- Men, or non-pregnant and non-lactating women
- Pathological diagnosis as gastric malignant tumor
- diagnosis of peritoneal metastasis [peritoneal cancer index (PCI) ≤ 12 points] by laparoscopic exploration
- Normal major organ function: 1) HB ≥ 90 g/L； ANC ≥ 1.5×109/L; plt ≥125×109/L; 2) TBIL\<1.5ULN; ALT, AST \<2.5ULN; Cr≤1.25ULN; ALB ≥ 30 g/L 6. Not receive radiation therapy, chemotherapy, targeted therapy, or...
- Patients have other malignant tumors within the past 5 years.
- Patients use immunosuppressant within 30 days prior to the initial use of tirelizumab, excluding nasal sprays and physiological doses of inhaled corticosteroids or systemic steroids from consideration.
- Patients have a documented history of ongoing autoimmune conditions or prior autoimmune diseases.
- Patients are allergic to oxaliplatin, S-1, other related chemotherapy drugs or immune checkpoint inhibitors.
- Patients with epilepsy or other mental disorders.
- Patients who are unable to undergo surgery due to severe heart, lung and vascular diseases.
- Pregnant or lactating women.
- Patients with other distant metastasis
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, 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 Wuhan, Hubei, 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.