Peritoneal MesotheliomaNCT07330271
PTC-Guided Therapy for Peritoneal Mesothelioma
A study testing PTC guided individualized treatment and Standard chemotherapy regimens in people with Peritoneal Mesothelioma, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Peritoneal Mesothelioma
- What is being tested?
- PTC guided individualized treatment and Standard chemotherapy regimens
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 347 participants
- Where
- 1 siteChina
- Study dates
- 2 Dec 2025to 1 Nov 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tsinghua University affiliated Beijing Tsinghua Changgung Hospital
Beijing, 102218
Xinli Liang, +8615030413619, lxl9908152022@163.com
About this study
Official title: 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.
Read more
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. Additionally, if the patient's tumor tests positive for PD-L1 (≥1%), the immunotherapy drug Sintilimab will be given together with the chemotherapy.
- 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, and Shijiazhuang People's Hospital.
- Conditions
- Peritoneal Mesothelioma
- Being tested
- PTC guided individualized treatment, Standard chemotherapy regimens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTC guided individualized treatmentDrug
According to the PTC drug sensitivity test, the types of chemotherapy combined with targeted and immune drugs were determined
Standard chemotherapy regimensDrug
Patients in the control group receive gemcitabine + oxaliplatin + apatinib as standard chemotherapy. Additionally, if the tumor tests positive for PD-L1 (≥1%), the immunotherapy drug sintilimab is added.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Not described Receives: Drug: PTC guided individualized treatment |
| Control Group | Active comparator | Not described Receives: Drug: Standard chemotherapy regimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: From date of randomization until the date of death from any cause, assessed up to 5 years.
Secondary outcomes (1)
Progression-Free Survival
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start2 Dec 2025
- Primary completion1 Nov 2029 (estimated)
- Study completion1 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal MesotheliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 347 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Shijitan Hospital, Capital Medical University, Cangzhou Central Hospital, Shijiazhuang People's Hospital
- Responsible party
- Principal investigator, Yan Li, Beijing Tsinghua Chang Gung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330271
- Sponsor's protocol ID
- 25879-0-03
- Status last verified
- Jun 2026
- First submitted
- 26 Dec 2025
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Controlled Trial of PTC-Guided Personalized Therapy for Peritoneal Mesothelioma
- ClinicalTrials.gov ID
- NCT07330271
- Acronym / sponsor ID
- 25879-0-03
- Conditions
- Peritoneal Mesothelioma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 347 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Collaborators
- Beijing Shijitan Hospital, Capital Medical University, Cangzhou Central Hospital, Shijiazhuang People's Hospital
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- 1 Nov 2029 (estimated)
- Study completion
- 1 Nov 2031 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Additionally, if the patient's tumor tests positive for PD-L1 (≥1%), the immunotherapy drug Sintilimab will be given together with the chemotherapy.
- 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, and Shijiazhuang People's Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: PTC guided individualized treatment |
| Control Group | Active comparator | Drug: Standard chemotherapy regimens |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTC guided individualized treatmentAccording to the PTC drug sensitivity test, the types of chemotherapy combined with targeted and immune drugs were determined | Drug | Experimental Group |
| Standard chemotherapy regimensPatients in the control group receive gemcitabine + oxaliplatin + apatinib as standard chemotherapy. Additionally, if the tumor tests positive for PD-L1 (≥1%), the immunotherapy drug sintilimab is added. | Drug | Control Group |
Primary outcome
Overall Survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 5 years.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTC guided individualized treatment and Standard chemotherapy regimens in people with Peritoneal Mesothelioma, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinli Liang (+8615030413619, lxl9908152022@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: From date of randomization until the date of death from any cause, assessed up to 5 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.