RecruitingPhase 2NCT05188859

First Line Sintilimab Combined With Anlotinib and Platinum Doublet Chemotherapy in Malignant Pleural Mesothelioma

Study of Sintilimab Combined With Anlotinib and Platinum-Containing Dual-Agent Chemotherapy as First Line Therapy in Malignant Pleural Mesothelioma: A Single Arm, Open-label, Prospective Phase II Trial


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

29 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of three drugs — sintilimab (an immunotherapy), anlotinib (a targeted anti-cancer drug), and standard platinum-based chemotherapy — as first-line treatment for malignant pleural mesothelioma, a rare and aggressive cancer of the lung lining. **You may be eligible if...** - You are 18 or older with confirmed mesothelioma that is unresectable (cannot be removed with surgery) or has spread - You have not received prior systemic treatment for advanced disease - You are in good health (ECOG 0–1) with adequate organ function - If you have stable brain metastases after local treatment, you may still be eligible **You may NOT be eligible if...** - You have received prior immunotherapy (anti-PD-1, anti-PD-L1, anti-CTLA-4 drugs) - You have active autoimmune disease requiring systemic treatment - You have significant heart conditions or uncontrolled high blood pressure - You have uncontrolled fluid around the lungs that requires frequent draining - You are pregnant or breastfeeding - You have active hepatitis B, hepatitis C, or HIV Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSintilimab+Anlotinib+Pemetrexed+Cisplatin

Sintilimab 200mg+Anlotinib 12mg+Pemetrexed 500mg/m²+Cisplatin 75mg/m2


Locations(2)

Shanxi Provincial Cancer Hospital/ Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences/Cancer Hospital Affiliated to Shanxi Medical University

Taiyuan, Shanxi, China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

View Full Details on ClinicalTrials.gov

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NCT05188859


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