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

NCT03711279 | Terminated Phase 2 Results DMC

• 1 other identifier: SHR-1210-II-212
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma

Keywords

Sarcoma; SHR-1210; Apatinib

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Objective Response Rate (ORR)

  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.

Study Arms (2)

SHR-1210 plus Apatinib

EXPERIMENTAL

Drug: SHR-1210 plus Apatinib

ADM plus IFO or IFO alone

ACTIVE COMPARATOR

Drug: ADM plus IFO or IFO alone

Interventions

SHR-1210 plus Apatinib DRUG

SHR-1210 200 mg q3w+ Apatinib 500 mg qd

Also known as: PD-1 antibody + Anti-angiogenesis

SHR-1210 plus Apatinib

ADM plus IFO or IFO alone DRUG

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.

Also known as: chemotherapy

ADM plus IFO or IFO alone

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Sarcoma

Interventions

camrelizumab; apatinib; Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Project manager
• Organization: Jiangsu HengRui Pharmaceuticals Co., Ltd.

qianna.zhan@hengrui.com

+86-18036618962

Study Officials

• Yang Yao, M.D.

  Shanghai Jiao Tong University Affiliated Sixth People's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 18, 2018
• Study Start: November 22, 2018
• Primary Completion: June 21, 2021
• Study Completion: June 21, 2021
• Last Updated: February 29, 2024
• Results First Posted: February 29, 2024

Record last verified: 2023-07

Locations

CN (1)