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SCT-I10A Plus SCT510 Versus Sorafenib as First-Line Therapy for Advanced Hepatocellular Carcinoma (HCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04560894
Recruitment Status : Recruiting
First Posted : September 23, 2020
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Sinocelltech Ltd.

Study Description
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Brief Summary:
The purpose of the study is to assess the safety and effectiveness of SCT-I10A in combination with SCT510 in patients with HCC who have not received prior systemic therapy.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: SCT-I10A Drug: SCT510 Drug: Sorafenib 200mg Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 621 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SCT-I10A in Combination With SCT510 Versus Sorafenib as First-Line Therapy for Advanced Hepatocellular Carcinoma (HCC): A Multicenter, Randomized, Open-label,Phase 2/3 Trial
Actual Study Start Date : November 11, 2020
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : September 2024

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: SCT-I10A+SCT510 Drug: SCT-I10A
Participants receive SCT-I10A intravenously，200mg，d1，Q3w

Drug: SCT510
Participants receive SCT510 intravenously，15mg/kg，d1，Q3w
Active Comparator: Sorafenib Drug: Sorafenib 200mg
Participants receive sorafenib orally，400mg bid


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: up to 3years ]
  2. Progression-free survival(PFS)evaluated by the Blinded Independent Central Review Committee (BICR) based on RECIST V1.1 [ Time Frame: up to 3years ]

Secondary Outcome Measures :
  1. PFS [ Time Frame: up to 3years ]
    PFS evaluated by investigator based on RECIST V1.1

  2. PFS [ Time Frame: up to 3years ]
    PFS evaluated by BICR based on mRECIST.

  3. Objective response rate (ORR) [ Time Frame: up to 3years ]
    ORR evaluated by BICR based on RECIST V1.1.

  4. ORR [ Time Frame: up to 3years ]
    ORR evaluated by BICR based on mRECIST.

  5. ORR [ Time Frame: up to 3years ]
    ORR evaluated by investigator based on RECIST V1.1

  6. Serum concentration of SCT-I10A and SCT510 [ Time Frame: up to 3years ]
  7. Anti-drug antibody (ADA) [ Time Frame: up to 3years ]

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:

  • Participants must have a diagnosis of HCC not suitable for radical surgery and/or local treatment，or progressed after surgery and/or local treatment.
  • No prior systemic therapy for HCC(End of postoperative adjuvant chemotherapy for more than 6 months allowed).
  • Child-Pugh ≤7 , no history of hepatic encephalopathy.
  • Barcelona Clinic Liver Cancer stage B, not suitable for local treatment and BCLC C.
  • At least one measurable lesion based on Recist1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Adequate hematologic and organ function.

Exclusion Criteria:

  • Local treatment or surgery for liver lesions within 4 weeks.
  • Prior liver or other organ transplantation.
  • Active Central nervous system (CNS) metastasis or leptomeningeal metastases.
  • Gastrointestinal perforation and/or fistula or intraperitoneal abscess within 6 months prior to the start of study treatment.
  • Hemorrhage tendency or high-risk for bleeding , severe coagulation disorders.
  • Active known, or suspected autoimmune disease.
  • Any condition that is not suitable for participate in this study as determined by investigator.
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): NCT04560894


Contacts
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Contact: jianming xu, MD +8613910866712 jmxu2003@163.com

Locations
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China, Beijing
307 Hospital of PLA Recruiting
Beijing, Beijing, China, 100071
Contact: jianming xu, MD    +8613910866712    jmxu2003@163.com   
Sponsors and Collaborators
Sinocelltech Ltd.
More Information
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Responsible Party: Sinocelltech Ltd.
ClinicalTrials.gov Identifier: NCT04560894    
Other Study ID Numbers: SCT-I10A-C301
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action