Clinical Study of PD-1 Monoclonal Antibody SHR-1210 and Apatinib in Advanced NSCLC, Soft Tissue Sarcoma, and Uterine Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Non Small Cell Lung Cancer
- Soft Tissue Sarcoma
- Uterine Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Patients fulfilling Eligibility Criteria will be included in our study. NSCLC participants will be given intravenous administration of SHR-1210 (200mg/2w) and oral of Apatinib (250mg/d) , soft tissue sarcoma will be given intravenous administration of SHR-1210 (200mg/3w) and oral of Apatinib (500mg/d), and uterine cancer will be given intravenous administration of SHR-1210 (200mg/3w) and oral of Apatinib (250mg/d). Treatments will be administrated until disease progression, death, or unacceptable toxicity.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
Description
Primary outcome: Analysis of baseline levels of CTC and CTC PD-L1 and prognosis efficacy of patients: Objective remission rate (ORR), progression free survival (PFS), overall survival (OS); Dynamic monitoring of CTC and CTC PD-L1 at baseline before treatment, after two cycles of treatment, and as th...
Primary outcome: Analysis of baseline levels of CTC and CTC PD-L1 and prognosis efficacy of patients: Objective remission rate (ORR), progression free survival (PFS), overall survival (OS); Dynamic monitoring of CTC and CTC PD-L1 at baseline before treatment, after two cycles of treatment, and as the disease progresses. Consistency analysis of PD-L1 and CTC PD-L1 expression in tissue specimens. Secondary outcome: Duration of response(DOR), Disease control rate(DCR), Safety of the combination therapy.
Tracking Information
- NCT #
- NCT04239443
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Investigators
- Principal Investigator: Nong Yang Hunan Cancer Hospital Principal Investigator: Kunyan Li Hunan Cancer Hospital Principal Investigator: Jing Wang Hunan Cancer Hospital Principal Investigator: Gang Huang Hunan Cancer Hospital
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