Brief Title
Neoadjuvant Toripalimab Combined With Chemotherapy in the Treatment of Malignant Pleural Mesothelioma
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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Major pathologic response (MPR)
Secondary Outcome
Overall survival (OS)
Condition
Malignant Pleural Mesothelioma
Intervention
Toripalimab
Study Arms / Comparison Groups
Toripalimab
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
15
Start Date
February 1, 2021
Completion Date
May 31, 2025
Primary Completion Date
January 31, 2022
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.
- Unsterilized male patients must voluntarily take effective contraceptive measures ≥
120 days after chemotherapy or the last administration of triplizumab, whichever is
the later.
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;
- 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.
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
, ,
Administrative Informations
NCT ID
NCT04713761
Organization ID
LungMate-010(FK-NEO-MPM-001)
Responsible Party
Principal Investigator
Study Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Study Sponsor
, ,
Verification Date
January 2021