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

NCT04713761 | Unknown Phase 2

• 1 other identifier: LungMate-010(FK-NEO-MPM-001)
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malignant Pleural Mesothelioma

Outcome Measures

Primary Outcomes (3)

• Major pathologic response (MPR)

  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.

  up to 4 months

• Health related quality of life (HRQol)

  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

  up to 6 months

• Safety: frequency of severe adverse events

  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.

  up to 5 months

Secondary Outcomes (4)

• 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

Study Arms (1)

Toripalimab

EXPERIMENTAL

Drug: Toripalimab

Interventions

Toripalimab DRUG

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).

Also known as: carboplatin, pemetrexed

Toripalimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Unsterilized male patients must voluntarily take effective contraceptive measures ≥ 120 days after chemotherapy or the last administration of triplizumab, whichever is the later.

You may not qualify if:

• 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;
• Pregnant or lactating women;
• Any malabsorption;
• Those with neurological diseases or mental disorders.
• Participated in another therapeutic clinical study at the same time;
• Other researchers did not consider it appropriate to enroll in the group.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

toripalimab; Carboplatin; Pemetrexed

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of thoracic department

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 19, 2021
• Study Start: February 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: May 31, 2025
• Last Updated: January 26, 2021

Record last verified: 2021-01