PTC-Guided Therapy for Peritoneal Mesothelioma

January 8, 2026 updated by: Yan Li, Beijing Tsinghua Chang Gung Hospital

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

Official Title: A Study of Key Parameters and Mechanisms in Personalized Diagnosis and Treatment Using Tumor Models

Why is this study being done? This research study is for adults with a type of cancer called Malignant Peritoneal Mesothelioma (MPM). Currently, it is hard for doctors to know which treatment will work best for each patient after surgery. This study will test a new, personalized way to choose treatments using a model grown from a patient's own tumor in the lab, called a Patient-derived tumor-like cell cluster (PTC) model. The main goal is to see if using this PTC model to guide treatment can help patients live longer without their cancer getting worse, compared to a standard chemotherapy treatment.

Who can participate? Adults aged 18 and older with a specific type of MPM (epithelioid or biphasic) who are planned to have surgery and heated chemotherapy (CRS+HIPEC) and can provide a tumor sample for the PTC model may be eligible.

What will happen in the study?

  • Participants will be randomly assigned to one of two groups by chance, like flipping a coin.
  • Standard Treatment Group: This group will receive the standard chemotherapy combination of Gemcitabine, Oxaliplatin, and Apatinib.
  • Personalized Treatment Group: This group will have a PTC model made from their tumor. The model will be tested with different drugs (chemotherapy, targeted therapy, and immunotherapy) in the lab. The treatment that works best on the model will be chosen for the patient.
  • Both groups will receive their assigned treatment for 6 cycles.
  • Participants will be followed for several years to see how they are doing, through clinic visits and scans.

What are the possible benefits? Participants in the personalized treatment group might receive a therapy that is more effective for their specific cancer. The information from this study may help doctors better treat future patients with MPM.

What are the possible risks? The risks include side effects from cancer treatments, which can include low blood cell counts, nausea, vomiting, high blood pressure, liver problems, and tiredness. There is also a risk that the PTC model may not grow successfully in the lab, or that the drug that works in the model may not work as well in the body. The study team will closely monitor all participants for any side effects and manage them promptly.

Who is paying for the study? This study is funded by the National Key R&D Program of China.

Where is the study taking place? The study is conducted at multiple hospitals in China, including Beijing Tsinghua Changgung Hospital, Beijing Shijitan Hospital, and Cangzhou Central Hospital.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

347

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 102218
        • Recruiting
        • Tsinghua University affiliated Beijing Tsinghua Changgung Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Drug: PTC guided individualized treatment
According to the PTC drug sensitivity test, the types of chemotherapy combined with targeted and immune drugs were determined
Active Comparator: Control Group
Drug: Standard chemotherapy regimens
According to the previous study, the patient received gemcitabine + oxaliplatin + apatinib standard treatment regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: From date of randomization until the date of death from any cause, assessed up to 5 years.
From date of randomization until the date of death from any cause, assessed up to 5 years.

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-Free Survival
Time Frame: From date of randomization until the date of first documented disease progression or death from any cause, whichever comes first, assessed up to 5 years.
From date of randomization until the date of first documented disease progression or death from any cause, whichever comes first, assessed up to 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tsinghua Chang Gung Hospital

Collaborators

Beijing Shijitan Hospital, Capital Medical University
Cangzhou Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2025

Primary Completion (Estimated)

November 1, 2029

Study Completion (Estimated)

November 1, 2031

Study Registration Dates

First Submitted

December 26, 2025

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 25879-0-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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