A Study of SHR-1210 Plus Apatinib in Patients With Soft Tissue Sarcoma

  • participants needed
  • sponsor
    Jiangsu HengRui Medicine Co., Ltd.
Updated on 27 November 2022
measurable disease
kidney function tests
cancer chemotherapy
soft tissue sarcoma
metastatic soft tissue sarcoma


The main purpose of this study is to evaluate the efficacy of SHR-1210 plus Apatinib versus AMD plus IFO in participants with soft tissue sarcoma.


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.

Condition Sarcoma
Treatment SHR-1210 Plus Apatinib, ADM Plus IFO or IFO Alone
Clinical Study IdentifierNCT03711279
SponsorJiangsu HengRui Medicine Co., Ltd.
Last Modified on27 November 2022

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