Actively Recruiting
PTC-Guided Therapy for Peritoneal Mesothelioma
Led by Beijing Tsinghua Chang Gung Hospital · Updated on 2026-01-09
347
Participants Needed
1
Research Sites
308 weeks
Total Duration
On this page
Sponsors
B
Beijing Tsinghua Chang Gung Hospital
Lead Sponsor
B
Beijing Shijitan Hospital, Capital Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
PTC-Guided Therapy for Peritoneal Mesothelioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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, AST, and 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.
You will not qualify if you...
- Presence of concurrent severe medical comorbidities that preclude tolerance to the study treatment.
- Diagnosis of another active malignant tumor during the screening process.
- Considered unsuitable for participation for psychological, familial, or social reasons.
- Unwillingness to accept the assigned treatment regimen or the required follow-up schedule.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tsinghua University affiliated Beijing Tsinghua Changgung Hospital
Beijing, China, 102218
Actively Recruiting
Research Team
X
Xinli Liang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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