- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04560894
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
-
-
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
|
Participants receive sorafenib orally,400mg bid
|
Experimental: SCT-I10A+SCT510
|
Participants receive SCT-I10A intravenously,200mg,d1,Q3w
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
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
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Sorafenib
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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