Clinical trial NCT03711279: A Study of SHR-1210 Plus Apatinib in Patients With Soft Tissue Sarcoma
Official title: A Multicenter, Randomized, Open, Phase 2 Trial of SHR-1210 Plus Apatinib Versus Doxorubicin (ADM) Plus Ifosfamide (IFO) in Patients With Soft Tissue Sarcoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Sarcoma
Keywords: Sarcoma
SHR-1210
Apatinib
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-10-18
Enrollment: 99
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 31 months, CT was conducted at baseline、weeks 7、13、19 and then every 12 weeks.
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From date of randomization until the date of study completion, an average of 1 year, CT was conducted at baseline、weeks 7、13、19 and then every 12 weeks.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
name: Yang Yao, M.D.
role: PRINCIPAL_INVESTIGATOR
References: