A Study of SHR-1210 Plus Apatinib in Patients With Soft Tissue Sarcoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Sarcoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 16 years and 70 years
- Gender
- Both males and females
Description
In this study, patients are randomly assigned in a 1:1 ratio to receive SHR-1210 plus Apatinib (SHR-1210 treatment up to 2 years) or ADM plus IFO 6 cycles. Randomisation balances patients by ECOG performance status (0 vs 1-2), histological tumour type and chemotherapy history. Tumour response is ass...
In this study, patients are randomly assigned in a 1:1 ratio to receive SHR-1210 plus Apatinib (SHR-1210 treatment up to 2 years) or ADM plus IFO 6 cycles. Randomisation balances patients by ECOG performance status (0 vs 1-2), histological tumour type and chemotherapy history. Tumour response is assessed every 6 weeks according to the Response Evaluation Criteria in Solid Tumours, version 1.1. Survival is assessed every 2 months until study completion. Blood samples are collected for pharmacokinetic and immunogenic analyses. Safety is assessed for all patients who received at least one dose of study treatment. Adverse events and clinical laboratory toxicity are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.
Tracking Information
- NCT #
- NCT03711279
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Yang Yao, M.D. Shanghai Jiao Tong University Affiliated Sixth People's Hospital
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