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NCT03711279

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

Terminated Phase 2 Results posted Last updated 29 February 2024
What this trial tests

Phase 2 trial testing SHR-1210 plus Apatinib in Sarcoma in 99 participants. Terminated before completion.

Timeline
22 November 2018
Primary endpoint
21 June 2021
21 June 2021

Quick facts

Lead sponsorJiangsu HengRui Medicine Co., Ltd.
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment99
Start date22 November 2018
Primary completion21 June 2021
Estimated completion21 June 2021
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Jiangsu HengRui Medicine Co., Ltd. — full company profile →

Who can join

Adults 16 to 70, any sex, with Sarcoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Progression Free Survival (PFS) Primary · 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)

GroupValue95% CI
SHR-1210 Plus Apatinib5.64.1 – 6.9
ADM Plus IFO or IFO Alone5.53.5 – 8.4
Objective Response Rate (ORR) Secondary · 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.

GroupValue95% CI
SHR-1210 Plus Apatinib11
ADM Plus IFO or IFO Alone5

Adverse events — posted to ClinicalTrials.gov

Time frame: 18 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SHR-1210 Plus Apatinib
Serious: 27/50 (54%)
Deaths: 2/50
ADM Plus IFO or IFO Alone
Serious: 13/47 (28%)
Deaths: 2/47

Serious adverse events (41 terms)

ReactionSystemSHR-1210 Plus ApatinibADM Plus IFO or IFO Alone
AnemiaBlood and lymphatic system disorders
Alanine aminotransferase increasedInvestigations
White blood cell count decreasedInvestigations
Neutrophil count decreasedInvestigations
Aspartate aminotransferase increasedInvestigations
Platelet count decreasedInvestigations
Drug-induced liver injuryHepatobiliary disorders
PyrexiaGeneral disorders
Liver injuryHepatobiliary disorders
Lymphocyte count decreasedInvestigations
Pathological fractureMusculoskeletal and connective tissue disorders
Febrile neutropeniaBlood and lymphatic system disorders
Immune-mediated hepatitisHepatobiliary disorders
Gamma-glutamyltransferase increasedInvestigations
Impaired healingGeneral disorders
HerniaGeneral disorders
InfectionInfections and infestations
PneumoniaInfections and infestations
Septic shockInfections and infestations
Wound infectionInfections and infestations
Urinary tract infectionInfections and infestations
Intestinal obstructionGastrointestinal disorders
DiarrheaGastrointestinal disorders
Immune-mediated enterocolitisGastrointestinal disorders
VomitingGastrointestinal disorders
Other adverse events (97 terms — click to expand)

ReactionSystemSHR-1210 Plus ApatinibADM Plus IFO or IFO Alone
AnaemiaBlood and lymphatic system disorders
Aspartate aminotransferase increasedInvestigations
Alanine aminotransferase increasedInvestigations
ProteinuriaRenal and urinary disorders
HypertensionVascular disorders
White blood cell count decreasedInvestigations
Platelet count decreasedInvestigations
Lymphocyte count decreasedInvestigations
DiarrhoeaGastrointestinal disorders
Gamma-glutamyltransferase increasedInvestigations
NauseaGastrointestinal disorders
Weight decreasedInvestigations
RashSkin and subcutaneous tissue disorders
Neutrophil count decreasedInvestigations
Palmar-plantar erythrodysaesthesia syndromeSkin and subcutaneous tissue disorders
AlopeciaSkin and subcutaneous tissue disorders
HypothyroidismEndocrine disorders
VomitingGastrointestinal disorders
Blood alkaline phosphatase increasedInvestigations
Blood bilirubin increasedInvestigations
Mouth ulcerationGastrointestinal disorders
ConstipationGastrointestinal disorders
Decreased appetiteMetabolism and nutrition disorders
HeadacheNervous system disorders
AstheniaGeneral disorders
PyrexiaGeneral disorders
Blood thyroid stimulating hormone increasedInvestigations
Blood lactate dehydrogenase increasedInvestigations
Bilirubin conjugated increasedInvestigations
CoughRespiratory, thoracic and mediastinal disorders
HypocalcaemiaMetabolism and nutrition disorders
Blood bilirubin unconjugated increasedInvestigations
DizzinessNervous system disorders
HyponatraemiaMetabolism and nutrition disorders
HypokalaemiaMetabolism and nutrition disorders
Sinus tachycardiaCardiac disorders
HyperthyroidismEndocrine disorders
Reactive capillary endothelial proliferationImmune system disorders
Electrocardiogram T wave abnormalInvestigations
ArthralgiaMusculoskeletal and connective tissue disorders

Most-reported serious reactions: Anemia, Alanine aminotransferase increased, White blood cell count decreased, Neutrophil count decreased, Aspartate aminotransferase increased, Platelet count decreased, Drug-induced liver injury, Pyrexia.

Data from ClinicalTrials.gov NCT03711279 adverse events section.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Improving Immunotherapy Efficacy in Soft-Tissue Sarcomas: A Biomarker Driven and Histotype Tailored Review.
    Roulleaux Dugage M, Nassif EF, Italiano A, Bahleda R. · · 2021 · cited 73× · PMID 34925348 · DOI 10.3389/fimmu.2021.775761
  2. Receptor tyrosine kinase inhibitors for the treatment of osteosarcoma and Ewing sarcoma.
    Just MA, Van Mater D, Wagner LM. · · 2021 · cited 23× · PMID 33894051 · DOI 10.1002/pbc.29084
  3. Recent advances and application of PD-1 blockade in sarcoma.
    Zuo W, Zhao L. · · 2019 · cited 15× · PMID 31692518 · DOI 10.2147/ott.s220045
  4. Trends in clinical development of pediatric cancer for PD-1 and PD-L1 inhibitors: an analysis of ClinicalTrials.gov.
    Que Y, Hu Y, Hong D, Zhang Y. · · 2021 · cited 11× · PMID 34583971 · DOI 10.1136/jitc-2021-002920
  5. Enhancing the Potential of Immunotherapy in Paediatric Sarcomas: Breaking the Immunosuppressive Barrier with Receptor Tyrosine Kinase Inhibitors.
    Fleuren EDG, Terry RL, Meyran D, Omer N, et al · · 2021 · cited 9× · PMID 34944614 · DOI 10.3390/biomedicines9121798

Verify or expand the search:

Other recruiting trials for Sarcoma

Currently open trials in the same condition.

Other Jiangsu HengRui Medicine Co., Ltd. trials

Trials by the same sponsor.

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Data sources for this page

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