PTC-guided treatment for peritoneal mesothelioma

A Multicenter, Randomized Controlled Trial of PTC-Guided Personalized Therapy for Peritoneal Mesothelioma

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 347 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Beijing Tsinghua Chang Gung Hospital (Academic / other)
• Drugs / interventions: chemotherapy, Apatinib, immunotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT07330271 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Beijing

• Tsinghua University affiliated Beijing Tsinghua Changgung Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Xinli Liang

Conditions Peritoneal Mesothelioma