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

February 27, 2024 updated by: Jiangsu HengRui Medicine Co., Ltd.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

In this study, patients are randomly assigned in a 1:1 ratio to receive SHR-1210 plus Apatinib (SHR-1210 treatment up to 2 years) or ADM plus IFO 6 cycles. Randomisation balances patients by ECOG performance status (0 vs 1-2), histological tumour type and chemotherapy history. Tumour response is assessed every 6 weeks according to the Response Evaluation Criteria in Solid Tumours, version 1.1. Survival is assessed every 2 months until study completion. Blood samples are collected for pharmacokinetic and immunogenic analyses. Safety is assessed for all patients who received at least one dose of study treatment. Adverse events and clinical laboratory toxicity are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHR-1210 plus Apatinib
Drug: SHR-1210 plus Apatinib
SHR-1210 200 mg q3w+ Apatinib 500 mg qd
Other Names:
  • PD-1 antibody + Anti-angiogenesis
Active Comparator: ADM plus IFO or IFO alone
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.
Other Names:
  • chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Investigators

  • Principal Investigator: Yang Yao, M.D., Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2018

Primary Completion (Actual)

June 21, 2021

Study Completion (Actual)

June 21, 2021

Study Registration Dates

First Submitted

October 16, 2018

First Submitted That Met QC Criteria

October 16, 2018

First Posted (Actual)

October 18, 2018

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-1210-II-212

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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