Trials / Recruiting
RecruitingNCT05188859
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 29 (estimated)
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Patients with advanced or metastatic (stage IIIB or IV) pleural mesothelioma who had not received previous systemic therapy were screened for eligible subjects to be eligible for enrollment after signing an written informed consent to receive Sintilimab combined with Anlotinib hydrochloride and platinum-containing dual-agent chemotherapy until disease progression (PD), intolerable toxicity, withdrawal of informed consent, initiation of other antineoplastic therapy, death or other situations for which protocol specified treatment should be discontinued (whichever occurs first). The maximum duration of treatment with Sintilimab is 24 months (in general).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sintilimab+Anlotinib+Pemetrexed+Cisplatin | Sintilimab 200mg+Anlotinib 12mg+Pemetrexed 500mg/m²+Cisplatin 75mg/m2 |
Timeline
- Start date
- 2024-09-01
- Primary completion
- 2026-09-01
- Completion
- 2027-09-01
- First posted
- 2022-01-12
- Last updated
- 2025-05-31
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05188859. Inclusion in this directory is not an endorsement.