Combining chemotherapy and immune therapy with heated chemotherapy for gastric cancer with peritoneal spread
Phase Ⅱ Study of Systemic Chemotherapy and Immune Checkpoint Inhibitors Combined With Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Gastric Cancer Patients With Peritoneal Metastasis
PHASE2 · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · NCT06685887
This study is testing a new treatment that combines heated chemotherapy with regular chemotherapy and immune therapy to see if it helps people with advanced gastric cancer that has spread to the lining of the abdomen.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (other) |
| Drugs / interventions | tirelizumab, chemotherapy, immunotherapy, radiation, nivolumab, Tislelizumab |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06685887 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a single-center, phase II investigation that evaluates the effectiveness of hyperthermic intraperitoneal chemotherapy (HIPEC) combined with systemic chemotherapy and immune checkpoint inhibitors in patients suffering from gastric cancer with peritoneal metastasis. The study aims to determine the impact of this treatment regimen on the rate of complete tumor resection (R0), overall survival, progression-free survival, and the incidence of adverse reactions. By utilizing a comprehensive treatment protocol, the trial seeks to enhance the prognosis for patients facing this advanced stage of gastric cancer.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-75 with a confirmed diagnosis of gastric cancer and peritoneal metastasis, who meet specific health criteria.
Not a fit: Patients with other malignant tumors within the past five years or those who have received prior treatments such as radiation or chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could significantly improve survival rates and quality of life for patients with advanced gastric cancer and peritoneal metastasis.
How similar studies have performed: While HIPEC combined with systemic therapies has shown promise in other studies, this specific combination is still being evaluated and represents a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18-75 years 2. Men, or non-pregnant and non-lactating women 3. Pathological diagnosis as gastric malignant tumor 4. diagnosis of peritoneal metastasis \[peritoneal cancer index (PCI) ≤ 12 points\] by laparoscopic exploration 5. 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 immunotherapy. 7\. Eastern Cooperative Oncology Group Performance Status (ECOG): 0-1 8. Patients are volunteers, have signed informed consent, and agree to cooperate with investigators in data collection. Exclusion Criteria: 1. Patients have other malignant tumors within the past 5 years. 2. 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. 3. Patients have a documented history of ongoing autoimmune conditions or prior autoimmune diseases. 4. Patients are allergic to oxaliplatin, S-1, other related chemotherapy drugs or immune checkpoint inhibitors. 5. Patients with epilepsy or other mental disorders. 6. Patients who are unable to undergo surgery due to severe heart, lung and vascular diseases. 7. Pregnant or lactating women. 8. Patients with other distant metastasis
Where this trial is running
Wuhan, Hubei
- Wuhan Union Hospital — Wuhan, Hubei, China (RECRUITING)
Study contacts
- Principal investigator: Kaixiong Tao, PhD — Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study coordinator: Kaixiong Tao, PhD
- Email: taokaixiong@hust.edu.cn
- Phone: 13507155452
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastric Cancer, Peritoneal Metastasis, HIPEC, SOX, Tislelizumab