PTC-guided treatment for peritoneal mesothelioma
Official title: A Multicenter, Randomized Controlled Trial of PTC-Guided Personalized Therapy for Peritoneal Mesothelioma
Run by Beijing Tsinghua Chang Gung Hospital · NCT07330271 · Data updated 2026-11-12
This study will see if using a patient's own tumor-grown model (PTC) to pick post-surgery treatment helps adults with malignant peritoneal mesothelioma stay free of progression longer than standard chemotherapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 347 (estimated) |
| Sponsor | Beijing Tsinghua Chang Gung Hospital Academic / other |
| Drugs / interventions | chemotherapy, Sintilimab, Apatinib, immunotherapy |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | December 2, 2025 |
| Main results expected | November 1, 2029 |
| Study ends | November 1, 2031 |
| Registry record updated | June 15, 2026 |
| Trial ID | NCT07330271 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (≥18) with histologically confirmed epithelioid or biphasic malignant peritoneal mesothelioma who are fit for CRS+HIPEC, have KPS > 60, adequate organ function, and can provide sufficient fresh tumor tissue at surgery.
✕Probably not a fit
Patients with non-epithelioid (pure sarcomatoid) histology, those who cannot undergo CRS+HIPEC, or those without enough tumor sample for PTC generation are unlikely to benefit from the PTC-guided approach in this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with epithelioid or biphasic malignant peritoneal mesothelioma who are scheduled for cytoreductive surgery with HIPEC will provide fresh tumor tissue during surgery. The tissue is used to grow a patient-derived tumor-like cell cluster (PTC) model for lab drug-sensitivity testing. Treatment choices after surgery will follow either the PTC-guided recommendations or standard chemotherapy regimens according to the study plan. The main outcome is whether PTC-guided therapy prolongs time without cancer progression compared with standard care.
Why it matters
Potential benefit: If successful, this approach could help select more effective personalized therapies and extend the time patients live without their disease worsening.
How similar studies have gone: Using patient-derived tumor models and ex vivo drug testing has shown promising, but still preliminary, results in other tumor types and remains relatively unproven specifically for peritoneal mesothelioma.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients must meet ALL of the following criteria to be eligible for the study: * Aged 18 years or older. * Histopathologically confirmed diagnosis of epithelioid or biphasic malignant peritoneal mesothelioma (MPM). * Scheduled to undergo cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) and subsequent adjuvant therapy. * Availability of sufficient fresh tumor tissue sample obtained during surgery for Patient-derived tumor-like cell clusters (PTC) drug sensitivity testing. * Karnofsky Performance Status (KPS) score \> 60. * Adequate hematologic function: * White blood cell count ≥ 3.5 × 10⁹/L * Platelet count ≥ 80 × 10⁹/L * Adequate hepatic function: * Total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) \< 2 × upper limit of normal (ULN) * Adequate renal function: * Serum creatinine \< 1.2 × ULN * Adequate cardiac and pulmonary function to tolerate major surgery, as assessed by the investigator. * Voluntarily agrees to participate by providing written informed consent and demonstrates good compliance. Exclusion Criteria: Patients who meet ANY of the following criteria will be excluded from the study: * Presence of concurrent severe medical comorbidities that, in the investigator's judgment, preclude tolerance to the study treatment. * Diagnosis of another active malignant tumor during the screening process, which may interfere with the study outcomes. * Considered by the investigator to be unsuitable for participation in this study for any other reason (e.g., psychological, familial, or social factors). * Unwillingness to accept the assigned treatment regimen or the required follow-up schedule.
Where it's running
-
Tsinghua University affiliated Beijing Tsinghua Changgung Hospital
Beijing, China Recruiting
Study contacts
- Study coordinator: Xinli Liang
- Email: lxl9908152022@163.com
- Phone: +8615030413619
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.