Neoadjuvant Toripalimab Combined With Chemotherapy in the Treatment of Malignant Pleural Mesothelioma
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|ClinicalTrials.gov Identifier: NCT04713761|
Recruitment Status : Not yet recruiting
First Posted : January 19, 2021
Last Update Posted : January 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|Malignant Pleural Mesothelioma||Drug: Toripalimab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of Neoadjuvant Anti-PD-1 Drug Toripalimab Combined With Chemotherapy in the Treatment of Locally Advanced Epithelial or Mixed Tissue Malignant Pleural Mesothelioma|
|Estimated Study Start Date :||February 1, 2021|
|Estimated Primary Completion Date :||January 31, 2022|
|Estimated Study Completion Date :||May 31, 2025|
Neoadjuvant treatment stage: Toripalimab 240mg, Carboplatin AUC5+ pemetrexed 500 mg/m ², iv, 3 weeks per cycle, 2-4 cycles in total; Surgical treatment stage: Patients with MPM received surgical treatment (PD/EPP) after neoadjuvant therapy. Patients who were unable to operate or refused surgical treatment due to various reasons were treated with multidisciplinary discussion.
Adjuvant treatment stage: CR, PR and SD patients who have been treated surgically: Toripalimab 240mg, Carboplatin AUC5+ pemetrexed 500 mg/m ²,iv, up to 4 cycles (including neoadjuvant stage).
- Major pathologic response (MPR) [ Time Frame: up to 4 months ]MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery.
- Health related quality of life (HRQol) [ Time Frame: up to 6 months ]The assessment is made according to the Quality of Life Scale for Lung Cancer Patients (EORTC-QLQ-C30 & LC13, Version 3). EORTC's QLQ-C30 & LC13 (V3.0) is a core scale for lung cancer patients, with a total of 43 items. Among them, Item 29 and 30 are divided into seven grades, which are assigned with 1 to 7 scores according to the answer options. The other items are divided into 4 grades: No
- Safety: frequency of severe adverse events [ Time Frame: up to 5 months ]The frequency of severe adverse events from the participants enrolling to 30 days after the last drug administration or 30 days after surgery or new anti-cancer therapy, which comes first.
- Overall survival (OS) [ Time Frame: up to 60 months ]It is defined as the time from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date. In the event of a patient with the survival status unknown, the date when the patient is last known to be alive will be used for interpolation (censoring).
- Duration of remission (DOR) [ Time Frame: up to 60 months ]According to the time from the first recording of objective remission to relapse or death from any cause determined by RECISTv1.1, whichever occurs first.
- Disease control rate (DCR) [ Time Frame: up to 60 months ]The proportion of patients whose best overall remission (BOR) is CR, PR or disease stable (SD) according to RECISTv1.1 evaluation
- Progression-free survival (PFS) [ Time Frame: up to 60 months ]PFS is defined as the time from the enrollment of the subject to the first determination of disease progression or death of any cause according to RECISTv1.1, whichever occurs first.