Actively Recruiting
First Line Sintilimab Combined With Anlotinib and Platinum Doublet Chemotherapy in Malignant Pleural Mesothelioma
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-05-31
29
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
First Line Sintilimab Combined With Anlotinib and Platinum Doublet Chemotherapy in Malignant Pleural Mesothelioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before any trial-related procedures
- Age 18 years or older
- Histologically confirmed unresectable, inoperable, locally advanced (stage IIIB), recurrent, or metastatic (stage IV) malignant pleural mesothelioma
- At least one measurable lesion according to mRECIST1.1 criteria
- No prior systemic anti-tumor therapy for advanced or metastatic disease; prior platinum-containing adjuvant/neoadjuvant chemotherapy or radical radiotherapy allowed if at least 6 months since last treatment
- Patients with asymptomatic or stable brain metastases after local treatment meeting specific criteria
- Allowed to receive palliative radiotherapy if completed within 7 days before first study drug administration
- ECOG performance status of 0 or 1
- Expected survival time greater than 3 months
- Adequate organ function as defined by laboratory criteria including neutrophil count, platelet count, hemoglobin, liver enzymes, creatinine, coagulation, thyroid function, and myocardial enzymes
- Negative pregnancy test within 3 days before first study drug administration for women of childbearing potential
- Use of effective contraception during treatment and for 120 days after last study drug administration (or 180 days after last chemotherapy)
You will not qualify if you...
- Malignant diseases other than malignant pleural mesothelioma diagnosed within 5 years (except certain skin cancers)
- Participation in other interventional clinical trials or use of investigational drugs/devices within 4 weeks before first administration
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T cell receptor stimulating/inhibiting drugs
- Systemic therapy with proprietary Chinese medicine or immunomodulatory drugs within 2 weeks before first administration (except local pleural effusion control)
- Active autoimmune diseases requiring systemic treatment within 2 years before first administration
- Systemic glucocorticoid or immunosuppressive therapy within 7 days before first administration (physiological doses allowed)
- Clinically uncontrollable pleural effusion or ascites
- Known allogeneic organ transplantation (except corneal)
- Allergy to Sintilimab or its excipients
- Conditions affecting oral drug intake
- Symptomatic or uncontrolled brain metastasis
- Active hemoptysis within 3 months before first administration
- Tumors invading large blood vessels or with bleeding tendency
- Major surgery within 4 weeks before first administration or planned during study
- Severe unhealed wounds, ulcers, or fractures
- Minor surgery within 48 hours before first drug dose
- Use of high-dose aspirin or NSAIDs affecting platelets within 10 days before first dose
- Full-dose anticoagulant or thrombolytic therapy within 10 days before first dose (prophylactic low-dose allowed)
- Hereditary bleeding or coagulation disorders or thrombosis history
- Unresolved toxicity from prior treatments above grade 1 (except fatigue or hair loss)
- Known HIV infection
- Untreated active hepatitis B or C infection
- Live vaccine within 30 days before first administration
- Pregnant or lactating women
- Serious or uncontrollable systemic diseases affecting safety or study completion
- Investigator judgment of other potential risks or unsuitability for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
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
Actively Recruiting
2
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
Research Team
W
Wang, MD,PhD
CONTACT
D
Duan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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