Neoadjuvant Toripalimab Combined With Chemotherapy in the Treatment of Malignant Pleural Mesothelioma
NCT04713761 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2021-01-26
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
- 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).
Sponsors & Collaborators
-
Shanghai Pulmonary Hospital, Shanghai, China
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-02-01
- Primary Completion
- 2022-01-31
- Completion
- 2025-05-31
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