Malignant pleural mesothelioma
Conditions
Interventions
treatment group:Tislelizumab plus pemetrexed and cisplatin/carboplatin
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up; 2. Age is 18~80 years old, male or female; 3. Histologically or cytologically confirmed epithelial malignant pleural mesothelioma; 4. According to CT evaluation, the disease is confined to one side of the thoracic cavity; 5. Surgical resectable or potentially operable malignant pleural mesothelioma after MDT discussion; 6. ECOG score 0-1 points; 7. Expected survival time>= 3 months; 8. Adequate organ function; 9. Women of childbearing potential must have taken reliable contraceptive measures or have had a pregnancy test (serum or urine) within 7 days prior to enrollment with a negative result, and are willing to use an appropriate method of contraception during the trial and 60 days after the last administration of the trial drug. For males, they must agree to use an appropriate method of contraception or have been surgically sterilized for the duration of the trial and for 120 days after the last administration of the trial drug.
Exclusion criteria
Exclusion criteria: 1. Current participation in interventional clinical study treatment; 2. Severe tachypnea (defined as Eastern Cooperative Oncology Group (ECOG) status>=2, or if pulmonary function tests are performed: forced expiratory volume (FEV1) after one second before surgery or less than 20% of the lungs carbon monoxide transfer factor (TLco); 3. Severe concomitant illness that would jeopardize the participant's safety during surgery (e.g. evidence of end-organ failure); 4. Histologically confirmed diagnosis of advanced unresectable malignant pleural mesothelioma; 5. Pregnant or lactating women; 6. Presence of any severe or uncontrollable systemic disease. 7. Severe heart failure (defined as NYHA III or IV or ejection fraction less than 30% if echocardiogram is performed); 8. End-stage renal failure requiring dialysis; 9. Have hepatic failure (e.g. encephalopathy and/or coagulation abnormalities).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who undergo Pleurectomy/Decortication(P/D) surgery after neoadjuvant therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response rate;Progression free survival;Objective response rate;Median overall survival;security; | — |
Countries
China
Contacts
Public ContactHongyang Lu
Zhejiang Cancer Hospital
Outcome results
None listed