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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-22

Study Completion Date

2021-06-21

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.

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Detailed Description

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Conditions

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Sarcoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SHR-1210 plus Apatinib

Group Type EXPERIMENTAL

SHR-1210 plus Apatinib

Intervention Type DRUG

SHR-1210 200 mg q3w+ Apatinib 500 mg qd

ADM plus IFO or IFO alone

Group Type ACTIVE_COMPARATOR

ADM plus IFO or IFO alone

Intervention Type DRUG

ADM 60 mg/m2 D1 + IFO 2 g/m2 D1-D4 q3w；if the cumulative doses of ADM were beyond 450 mg/m2, the monotherapy of IFO (2 g/m2 D1-D5 q3w) would be used.

Interventions

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SHR-1210 plus Apatinib

SHR-1210 200 mg q3w+ Apatinib 500 mg qd

Intervention Type DRUG

ADM plus IFO or IFO alone

ADM 60 mg/m2 D1 + IFO 2 g/m2 D1-D4 q3w；if the cumulative doses of ADM were beyond 450 mg/m2, the monotherapy of IFO (2 g/m2 D1-D5 q3w) would be used.

Intervention Type DRUG

Other Intervention Names

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PD-1 antibody + Anti-angiogenesis chemotherapy

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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No