First Line Sintilimab Combined With Anlotinib and Platinum Doublet Chemotherapy in Maligna
This study is a single-arm, open-lable, single-center phase II clinical trial for patients with advanced or metastatic pleural mesothelioma. The aim of this study was to observe and evaluate the efficacy and safety of Sintilimab combined with Anlotinib hydrochloride and platinum-containing dual-agent chemotherapy as fi
| Condition(s) | Mesothelioma, Malignant, Mesothelioma, Malignant Pleural, Mesothelioma Malignant Advanced |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This study is a single-arm, open-lable, single-center phase II clinical trial for patients with advanced or metastatic pleural mesothelioma. The aim of this study was to observe and evaluate the efficacy and safety of Sintilimab combined with Anlotinib hydrochloride and platinum-containing dual-agent chemotherapy as first-line therapy in malignant pleural mesothelioma. |
| Who can participate | Inclusion Criteria: * Sign written informed consent before implementing any trial-related procedures; * Age ≥ 18 years old. * Histologically confirmed, unresectable or inoperable or locally advanced (IIIB stage), recurrent or metastatic (IV stage) malignant pleural mesothelioma. * According to the modified version of the evaluation criteria for the efficacy of solid tumor (mRECIST1.1 ), patients have at least one imaging lesion can be measured; * Patients have not received any systemic anti-tumor therapy for advanced/metastatic diseases in the past. Patients who have previously received platinum-containing adjuvant / neoadjuvant chemotherapy, or radical radiotherapy and chemotherapy for advanced diseases, such as the interval between disease progression or recurrence and the end of the las |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Locations | Taiyuan, Shanxi, China; Beijing, China |
| Start date | 2024-09-01 |
| NCT ID | NCT05188859 |
| Official listing | https://clinicaltrials.gov/study/NCT05188859 |