Peritoneal Mesothelioma
Conditions
Interventions
Experimental Group: PTC Drug Sensitivity Testing-Guided Personalized Therapy:1. Core Method: Following cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC), fresh tumor ti
Control Group: Standard Chemotherapy Group:Following CRS and HIPEC, patients receive postoperative adjuvant standard chemotherapy.
Specific Regimen: Gemcitabine 1000 mg/m^2 intravenous infusion (Day 1
Sponsors
Tsinghua University affiliated Beijing Tsinghua Changgung Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years. 2. Histologically confirmed diagnosis of epithelioid or biphasic malignant peritoneal mesothelioma. 3. Scheduled to undergo cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC), and planned for postoperative adjuvant therapy. 4. Availability of sufficient fresh tumor tissue samples obtained during surgery for the Patient-derived Tumor-like Cell Clusters (PTC) drug sensitivity test. 5. Karnofsky Performance Status (KPS) > 60. 6. Peripheral blood leukocyte count >= 3.5 × 10^9/L and platelet count >= 80 × 10^9/L. 7. Liver function: Total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) < 2 × upper limit of normal (ULN). 8. Renal function: Serum creatinine < 1.2 × ULN. 9. Adequate cardiac and pulmonary function to tolerate major surgery. 10. The subject voluntarily agrees to participate in the study by signing an informed consent form and is expected to have good compliance.
Exclusion criteria
Exclusion criteria: 1. Presence of concurrent severe medical conditions, rendering the patient unable to tolerate the study treatment as assessed by the investigator. 2. Diagnosis of another active malignant tumor during the evaluation process, which is likely to interfere with the assessment of the outcomes of this trial. 3. Considered by the investigator to be unsuitable for participation in the study due to potential risks or other reasons based on a comprehensive assessment. 4. Unwillingness or refusal to accept the proposed treatment regimen or the follow-up schedule stipulated in the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Progression-Free Survival (PFS); | — |
Countries
China
Contacts
Public ContactLi Yan
Tsinghua University affiliated Beijing Tsinghua Changgung Hospital
Outcome results
None listed