NCT05188859
First Line Sintilimab Combined With Anlotinib and Platinum Doublet Chemotherapy in Malignant Pleural Mesothelioma
Recruiting · Phase 2 · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · registry updated 2025-05-31
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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 last chemotherapeutic drug treatment at least 6 months, are allowed to be enrolled in this study.
- Patients with brain metastasis who are asymptomatic or stable after local treatment are allowed to be included in this study, as long as they meet the following conditions:
Exclusion
- Diagnosis of malignant diseases other than malignant pleural mesothelioma (excluding radical skin basal cell carcinoma, skin squamous cell carcinoma, and / or radical resection of carcinoma in situ) within 5 years before the first administration
- Currently participating in interventional clinical research treatment, or receiving other research drugs or using research instruments within 4 weeks before the first administration;
- Previous usage of the following treatments: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs, for another stimulating or synergistic inhibition of T cell receptors (for example, CTLA-4, OX-40, CD137) drug;
- Within 2 weeks before the first administration, they received systemic systemic therapy with anti-tumor indications of proprietary Chinese medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for controlling local use of pleural effusion)
- Active autoimmune diseases requiring systemic treatment (such as the use of disease-relieving drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration. Alternative therapy (such as thyroxine, insulin or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy.
- The patients are received systemic glucocorticoid therapy (excluding nasal, inhaled or other topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first administration.