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
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 主要终点
- Major pathologic response (MPR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Toripalimab
干预措施: Toripalimab (Drug)
结局指标
主要结局
Major pathologic response (MPR)
时间窗: 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)
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Peng Zhang
Director of thoracic department
Shanghai Pulmonary Hospital, Shanghai, China