Clinical trial · Interventional
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HIPEC | Drug | Hyperthermic Intraperitoneal Chemotherapy | ALIAS |
| Immune Checkpoint Inhibitors | Drug | — | UNRESOLVED |
| SOX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HIPEC combined with SOX and Tislelizumab
- description
- The participants volunteering to take HIPEC combined with SOX and immune checkpoint inhibitors will be assigned to this group.
- interventionNames
- Drug: HIPEC
- Drug: SOX
- Drug: Immune Checkpoint Inhibitors
Primary outcomes (1)
- measure
- R0 resection rate
- timeFrame
- 1 year
- description
- The proportion of patients who achieved R0 resection
Secondary outcomes (3)
- measure
- 1,2,3-year OS rate
- timeFrame
- up to 12/24/36-months follow-up
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available