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

Sarcoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03711279
• Other study ID #: SHR-1210-II-212
• Status: Terminated
• Phase: Phase 2
• Start date: November 22, 2018
• Est. completion date: June 21, 2021

Study information

• Verified date: July 2023
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 99
• Est. completion date: June 21, 2021
• Est. primary completion date: June 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sarcoma

Intervention

Drug:
• SHR-1210 plus Apatinib
SHR-1210 200 mg q3w+ Apatinib 500 mg qd
• 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.

Locations

Country	Name	City	State
China	Shanghai Jiao Tong University Affiliated Sixth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)	Randomization to Radiographic Progression or Death Due to Any Cause (Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions)	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	Objective Response Rate (ORR)	Baseline to documented disease Remission to study discontinuation, Partial Remission is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 30% decrease in the sum of the beaseline diameter of target lesions.	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.