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
Overview
- Phase
- Phase 2
- Intervention
- Toripalimab
- Conditions
- Malignant Pleural Mesothelioma
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Enrollment
- 15
- Primary Endpoint
- Major pathologic response (MPR)
- Status
- Not yet recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
This is a single-arm, open, II phase study to evaluate the safety and efficacy of Toripalimab, pemetrexed and carboplatin in the treatment of locally advanced malignant MPM in 15 newly diagnosed patients with locally advanced malignant MPM.
Investigators
Peng Zhang
Director of thoracic department
Shanghai Pulmonary Hospital, Shanghai, China
Eligibility Criteria
Inclusion Criteria
- •Sign informed consent;
- •Age ≥ 18 years;
- •Histology or cytology confirmed upper or mixed type of MPM, and previously untreated;
- •Imaging confirmed that MPM was locally advanced;
- •PET-CT confirmed no metastasis;
- •ECOG physical status score 0-1;
- •Life expectancy at least 12 weeks.
- •Have measurable lesions
- •Good function of other major organs (liver, kidney, blood system, etc.):-absolute neutrophil count ((ANC) ≥ 1.5 × 109), platelet (≥ 100 × 109), hemoglobin (≥ 90g/L). Note: patients shall not receive blood transfusion or growth factor support within 14 days before blood collection during the screening period;-International standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 × normal upper limit (ULN);-activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;- serum total bilirubin ≤ 1.5 × ULN (Gilbert syndrome patients with total bilirubin must be \< 3×ULN). Fertile female patients with aspartate and alanine aminotransferase (AST and ALT) ≤ 2.5 × ULN, or liver metastasis with AST and ALT ≤ 5 × ULN
- •Fertile female patients must voluntarily take effective contraceptive measures more than 120 days after chemotherapy or the last administration of triplizumab, whichever is later, and the urine or serum pregnancy test results less than 7 days before entering the group were negative.
Exclusion Criteria
- •Any systemic anticancer therapy for MPM, including surgery, local radiotherapy, cytotoxic drug therapy, targeted drug therapy and experimental therapy;
- •Any Chinese herbal medicine used to control cancer was used within 14 days before the first administration of the study drug;
- •Patients with malignant tumors other than MPM in the five years before the start of this trial.
- •Complicated with unstable systemic diseases such as uncontrolled hypertension, severe arrhythmias, etc.;
- •Active, known or suspected autoimmune diseases, or autoimmune paraneoplastic syndrome requiring systemic treatment;
- •Allergic to experimental drugs;
- •Previous or current interstitial lung disease;
- •Complicated with HIV infection or active hepatitis.
- •Those who were injected with vaccines or antibiotics within 4 weeks before the start of this trial, or who had undergone other major operations or severe injuries within the previous 2 months;
- •Clinically uncontrolled pleural effusion or ascites requiring pleural or abdominal puncture drainage within 2 weeks before admission;
Arms & Interventions
Toripalimab
Intervention: Toripalimab
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Overall survival (OS)(up to 60 months)
- Duration of remission (DOR)(up to 60 months)
- Disease control rate (DCR)(up to 60 months)
- Progression-free survival (PFS)(up to 60 months)