PTC-Guided Therapy for Peritoneal Mesothelioma

Last updated: January 8, 2026
Sponsor: Beijing Tsinghua Chang Gung Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Peritoneal Cancer

Mesothelioma

Abdominal Cancer

Treatment

PTC guided individualized treatment

Standard chemotherapy regimens

Clinical Study ID

NCT07330271
25879-0-02
  • Ages 18-85
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 malignantperitoneal mesothelioma (MPM).

  • Scheduled to undergo cytoreductive surgery (CRS) combined with hyperthermicintraperitoneal chemotherapy (HIPEC) and subsequent adjuvant therapy.

  • Availability of sufficient fresh tumor tissue sample obtained during surgery forPatient-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 bythe investigator.

  • Voluntarily agrees to participate by providing written informed consent anddemonstrates good compliance.

Exclusion

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'sjudgment, preclude tolerance to the study treatment.

  • Diagnosis of another active malignant tumor during the screening process, which mayinterfere with the study outcomes.

  • Considered by the investigator to be unsuitable for participation in this study forany other reason (e.g., psychological, familial, or social factors).

  • Unwillingness to accept the assigned treatment regimen or the required follow-upschedule.

Study Design

Total Participants: 347
Treatment Group(s): 2
Primary Treatment: PTC guided individualized treatment
Phase:
Study Start date:
December 02, 2025
Estimated Completion Date:
November 01, 2031

Connect with a study center

  • Tsinghua University affiliated Beijing Tsinghua Changgung Hospital

    Beijing 1816670, 102218
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.