Clincosm LogoSign in Get a demo

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

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03711279
Collaborator
(none)
289
Enrollment
1
Location
2
Arms
45.8
Anticipated Duration (Months)
6.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: SHR-1210 Plus Apatinib
  • Drug: ADM Plus IFO or IFO Alone
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
289 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 21, 2018
Anticipated Primary Completion Date :
Dec 15, 2020
Anticipated Study Completion Date :
Sep 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: SHR-1210 plus Apatinib

Drug: SHR-1210 Plus Apatinib
SHR-1210 (200mg lyophilized powder in a single-dose vial for reconstitution) q3w+ Apatinib (250mg/375mg tablets) qd
Other Names:
  • PD-1 antibody + Anti-angiogenesis

    		•
    Active Comparator: ADM Plus IFO or IFO Alone

    Drug: ADM Plus IFO or IFO Alone
    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.
    Other Names:
  • chemotherapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression Free Survival（PFS） [Randomization to 48months]

      Randomization to Radiographic Progression or Death Due to Any Cause

    Secondary Outcome Measures

    1. Overall Survival (OS) [Randomization to 48months]

      Randomization to Date of Death Due to Any Cause

    2. Objective Response Rate(ORR) [Randomization to 48months]

      Baseline to documented disease progression or study discontinuation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai Jiao Tong University Affiliated Sixth People's Hospital Shanghai Shanghai China

    Sponsors and Collaborators

    • Jiangsu HengRui Medicine Co., Ltd.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jiangsu HengRui Medicine Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT03711279
    Other Study ID Numbers:
    • SHR-1210-II-212
    First Posted:
    Oct 18, 2018
    Last Update Posted:
    Jul 26, 2019
    Last Verified:
    Jul 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jiangsu HengRui Medicine Co., Ltd.
    Sarcoma
    SHR-1210
    Apatinib
    Additional relevant MeSH terms:
    Sarcoma
    Apatinib

    Study Results

    No Results Posted as of Jul 26, 2019