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

January 30, 2024 updated by: Sinocelltech Ltd.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

405

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100071
        • 307 Hospital of PLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sorafenib
Drug: Sorafenib 200mg
Participants receive sorafenib orally，400mg bid
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: up to 3years
PFS evaluated by investigator based on RECIST V1.1
up to 3years
PFS
Time Frame: up to 3years
PFS evaluated by BICR based on mRECIST.
up to 3years
Objective response rate (ORR)
Time Frame: up to 3years
ORR evaluated by BICR based on RECIST V1.1.
up to 3years
ORR
Time Frame: up to 3years
ORR evaluated by BICR based on mRECIST.
up to 3years
ORR
Time Frame: up to 3years
ORR evaluated by investigator based on RECIST V1.1
up to 3years
Serum concentration of SCT-I10A and SCT510
Time Frame: up to 3years
up to 3years
Anti-drug antibody (ADA)
Time Frame: up to 3years
up to 3years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sinocelltech Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2020

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

September 17, 2020

First Submitted That Met QC Criteria

September 17, 2020

First Posted (Actual)

September 23, 2020

Study Record Updates

Last Update Posted (Actual)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCT-I10A-C301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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