search
Back to results

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

Primary Purpose

Sarcoma

Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR-1210 plus Apatinib
ADM plus IFO or IFO alone
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring Sarcoma, SHR-1210, Apatinib

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SHR-1210 plus Apatinib

ADM plus IFO or IFO alone

Arm Description

Outcomes

Primary Outcome Measures

Progression Free Survival（PFS）
Randomization to Radiographic Progression or Death Due to Any Cause

Secondary Outcome Measures

Overall Survival (OS)
Randomization to Date of Death Due to Any Cause
Objective Response Rate(ORR)
Baseline to documented disease progression or study discontinuation

Full Information

First Posted
October 16, 2018
Last Updated
June 15, 2023
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT03711279
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor R & D Strategy Adjustment
Study Start Date
November 22, 2018 (Actual)
Primary Completion Date
June 21, 2021 (Actual)
Study Completion Date
June 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
Sarcoma, SHR-1210, Apatinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SHR-1210 plus Apatinib
Arm Type
Experimental
Arm Title
ADM plus IFO or IFO alone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
SHR-1210 plus Apatinib
Other Intervention Name(s)
PD-1 antibody + Anti-angiogenesis
Intervention Description
SHR-1210 (200mg lyophilized powder in a single-dose vial for reconstitution) q3w+ Apatinib (250mg/375mg tablets) qd
Intervention Type
Drug
Intervention Name(s)
ADM plus IFO or IFO alone
Other Intervention Name(s)
chemotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression Free Survival（PFS）
Description
Randomization to Radiographic Progression or Death Due to Any Cause
Time Frame
Randomization to 48months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Randomization to Date of Death Due to Any Cause
Time Frame
Randomization to 48months
Title
Objective Response Rate(ORR)
Description
Baseline to documented disease progression or study discontinuation
Time Frame
Randomization to 48months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang Yao, M.D.
Organizational Affiliation
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
City
Shanghai
State/Province
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs