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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Open, Phase 2 Trial of SHR-1210 Plus Apatinib Versus Doxorubicin(ADM) Plus Ifosfamide（IFO）in Patients With Soft Tissue Sarcoma

Conditions
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Sarcoma

Intervention / Treatment
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* Drug: SHR-1210 plus Apatinib
* Drug: ADM plus IFO or IFO alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects with the age from 16 years to 70 years. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;the ECOG performance status of 2 can be accepted after the amputation. Life expectancy of at least 3 months. Histologically confirmed diagnosis of advanced unresectable or metastatic soft tissue sarcoma not amenable to curative treatment with surgery or radiotherapy.The histopathologic types as specified in the protocol. Without prior systemic chemotherapy or relapse more than 6 months after the completion of last systemic chemotherapy. Presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Acceptable liver function, renal function, hematologic status and coagulation function as specified in the protocol. Females of child-bearing potential must have a negative serum pregnancy test within 7 days prior to randomization.Females of child-bearing potential and males must agree to use highly effective contraceptive precautions during the trial and up to 3 months following the last dose of study drug. Willingness to comply with the study protocol for any reason. Exclusion Criteria: Receiving any previous anticancer treatment, other investigational drugs or any attenuated live vaccine with 4 weeks of the first does of study drug. Prior treatment with PD-1/PD-L1/CTLA-4 targeted drugs or VEGFR targeted drugs. Plan to receive surgery or radiotherapy to treat the sarcoma during the trail. Radiological evidence of brain metastases or primary tumors. Diagnosed other malignancies within the last 3 years from the first dose of drug. Known allergy to any of the treatment components. Active infection including human immunodeficiency virus (HIV) ,HBV or HCV. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR-1210 plus Apatinib<br> | Drug: SHR-1210 plus Apatinib<br>* SHR-1210 (200mg lyophilized powder in a single-dose vial for reconstitution) q3w+ Apatinib (250mg/375mg tablets) qd<br>* Other names: PD-1 antibody + Anti-angiogenesis;|
| Active Comparator: ADM plus IFO or IFO alone<br> | Drug: ADM plus IFO or IFO alone<br>* ADM 60mg/m2 D1 + IFO 2mg/m2 D1-D4 q3w；if the cumulative doses of ADM is beyond 450mg/m2, the monotherapy of IFO (2mg/m2 D1-D5 q3w) will be used.<br>* Other names: chemotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival（PFS） | Randomization to Radiographic Progression or Death Due to Any Cause | Randomization to 48months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | Randomization to Date of Death Due to Any Cause | Randomization to 48months | 
| Objective Response Rate(ORR) | Baseline to documented disease progression or study discontinuation | Randomization to 48months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarcoma, SHR-1210, Apatinib