PTC-Guided Therapy for Peritoneal Mesothelioma

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.

Conditions

• Peritoneal Mesothelioma

Interventions

DRUG

PTC guided individualized treatment

According to the PTC drug sensitivity test, the types of chemotherapy combined with targeted and immune drugs were determined

DRUG

Standard chemotherapy regimens

According to the previous study, the patient received gemcitabine + oxaliplatin + apatinib standard treatment regimen

Sponsors & Collaborators

• Beijing Shijitan Hospital, Capital Medical University

  collaborator OTHER

• Cangzhou Central Hospital

  collaborator OTHER

• Beijing Tsinghua Chang Gung Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-02

Primary Completion

2029-11-01

Completion

2031-11-01

Countries

• China

Study Locations