SarcomaPhase 2NCT03711279
A Study of SHR-1210 Plus Apatinib in Patients With Soft Tissue Sarcoma
A Phase 2 study testing SHR-1210 plus Apatinib and ADM plus IFO or IFO alone in people with Sarcoma, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Sarcoma
- What is being tested?
- SHR-1210 plus Apatinib and ADM plus IFO or IFO alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2018to 21 Jun 2021
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai, Shanghai Municipality
About this study
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
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
- Being tested
- SHR-1210 plus Apatinib, ADM plus IFO or IFO alone
- Keywords
- Sarcoma, SHR-1210, Apatinib
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1210 plus ApatinibDrug
Also called PD-1 antibody + Anti-angiogenesis
SHR-1210 200 mg q3w+ Apatinib 500 mg qd
ADM plus IFO or IFO aloneDrug
Also called chemotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| SHR-1210 plus Apatinib | Experimental | Not described Receives: Drug: SHR-1210 plus Apatinib |
| ADM plus IFO or IFO alone | Active comparator | Not described Receives: Drug: ADM plus IFO or IFO alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start22 Nov 2018
- Primary completion21 Jun 2021
- Study completion21 Jun 2021
Why it stopped: Sponsor R \& D Strategy Adjustment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yang Yao, M.D., Principal investigator, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711279
- Sponsor's protocol ID
- SHR-1210-II-212
- Status last verified
- Jul 2023
- First submitted
- 16 Oct 2018
- Last updated
- 29 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided