NCT04713761

Neoadjuvant Toripalimab Combined With Chemotherapy in the Treatment of Malignant Pleural Mesothelioma

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Pleural Mesothelioma

Interventions

Type	Name	Description
DRUG	Toripalimab	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).

Timeline

• Start date: 2021-02-01
• Primary completion: 2022-01-31
• Completion: 2025-05-31
• First posted: 2021-01-19
• Last updated: 2021-01-26