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A Study to Evaluate SHR-1210 in Combination With Apatinib as First-Line Therapy in Patients With Advanced HCC

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ClinicalTrials.gov Identifier: NCT03764293
Recruitment Status : Completed
First Posted : December 5, 2018
Results First Posted : February 6, 2024
Last Update Posted : February 6, 2024
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Study Description
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Brief Summary:
This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy and safety of SHR-1210 plus apatinib mesylate versus sorafenib as first-line therapy in patients with advanced HCC.

Condition or disease Intervention/treatment Phase
Locally Advanced or Metastatic and Unresectable HCC Drug: SHR-1210 Drug: Apatinib Drug: Sorafenib Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 543 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, International, Multi-Center, Phase 3 Clinical Study of PD-1 Antibody SHR-1210 Plus Apatinib Mesylate Versus Sorafenib as First-Line Therapy in Patients With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Previously Received Systemic Therapy
Actual Study Start Date : June 10, 2019
Actual Primary Completion Date : February 8, 2022
Actual Study Completion Date : June 14, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Sorafenib

Arms and Interventions
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Arm Intervention/treatment
Experimental: SHR-1210
SHR-1210+Apatinib
 Drug: SHR-1210
Subjects receive SHR-1210 intravenously, Dosage form: lyophilised powder, Strength: 200 mg /vial
Other Name: Camrelizumab

Drug: Apatinib
Subjects receive Apatinib orally, Dosage form: tablet, Strength: 250 mg/tablet
Other Name: Rivoceranib
Active Comparator: Control
Sorafenib
 Drug: Sorafenib
Subjects receive Sorafenib orally, Dosage form: tablet, Strength: 0.2 g/tablet


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to approximately 3 years ]
    OS was defined as the time from randomization to death from any cause.

  2. Progression-free Survival (PFS) Evaluated by the Blinded Independent Review Committee (BIRC) Based on RECIST v1.1 [ Time Frame: Up to approximately 3 years ]
    PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) by tumor image evaluation or death from any cause whichever occurs first as determined by BIRC according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions and the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm), or a measurable increase in a non-target lesion, or the appearance of new lesions.


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to approximately 3 years ]
    ORR defined as the percentage of subjects with complete response (CR) or partial response (PR) evaluated by the BIRC or investigator based on RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. Overall Response (OR)=CR+PR.

  2. Disease Control Rate (DCR) [ Time Frame: Up to approximately 3 years ]
    DCR defined as the percentage of subjects with complete response, partial response or stable disease (SD) ≥ 8 weeks evaluated by the BIRC or investigator based on RECIST v1.1. Complete response (CR) was defined as Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

  3. Duration of Response (DOR) [ Time Frame: Up to approximately 3 years ]
    DOR defined as time from the date of first record of objective response (CR or PR) to the first occurrence of radiological progression or death, whichever comes first, evaluated by the BIRC or investigator based on RECIST v1.1. Complete response (CR) was defined as Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histopathologically or cytologically confirmed advanced HCC
  • No previous systematic treatment for HCC
  • Have at least one measurable lesion (in accordance with RECIST v1.1)
  • BCLC stage B or C, and not suitable for surgical or local therapy, or has progressed following surgical and/or local therapy
  • ECOG-PS score 0 or 1
  • Child-Pugh Class: Grade A
  • Life Expectancy of at least 12 weeks
  • Subjects with HBV infection: HBV DNA<500 IU/ml or < 2500 copy/mL, and have received anti-HBV therapy for at least 14 days prior to enrollment in the study
  • Subjects with HCV-RNA(+) must receive antiviral therapy
  • Adequate organ function

Exclusion Criteria:

  • Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously
  • Moderate-to-severe ascites with clinical symptoms
  • History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage
  • Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
  • Known genetic or acquired hemorrhage or thrombotic tendency
  • Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
  • Cardiac clinical symptom or disease that is not well controlled
  • Hypertension that can not be well controlled through antihypertensive drugs
  • Factors to affect oral administration
  • History of hepatic encephalopathy
  • Previous or current presence of metastasis to central nervous system
  • HIV infection
  • Combined hepatitis B and hepatitis C co-infection
  • Be ready for or previously received organ or allogenic bone marrow transplantation
  • Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity
  • Active known, or suspected autoimmune disease
  • Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of first administration of study treatment
  • Use of potent CYP3A4 inducers or inhibitors within 2 weeks prior to the signature of ICF
  • Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug
  • Severe infection within 4 weeks prior to the start of study treatment
  • Palliative radiotherapy for non-target lesions to control symptoms is allowed, but it must be completed at least 2 weeks prior to the start of study treatment
  • Treatment of other investigational product(s) within 28 days prior to the start of study treatment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03764293


Locations
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Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Principal Investigator: Shukui Qin, MD Eastern Theater General Hospital,QinHuai District Medical Area
  Study Documents (Full-Text)

Documents provided by Jiangsu HengRui Medicine Co., Ltd.:
Study Protocol  [PDF] September 21, 2022
Statistical Analysis Plan  [PDF] April 19, 2022

More Information
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03764293    
Other Study ID Numbers: SHR-1210-III-310
First Posted: December 5, 2018    Key Record Dates
Results First Posted: February 6, 2024
Last Update Posted: February 6, 2024
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sorafenib
Apatinib
Antineoplastic Agents
 Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action