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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04560894
Other study ID # SCT-I10A-C301
Secondary ID
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date November 11, 2020
Est. completion date September 2024

Study information

Verified date January 2024
Source Sinocelltech Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 405
Est. completion date September 2024
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Drug:
SCT-I10A
Participants receive SCT-I10A intravenously,200mg,d1,Q3w
SCT510
Participants receive SCT510 intravenously,15mg/kg,d1,Q3w
Sorafenib 200mg
Participants receive sorafenib orally,400mg bid

Locations

Country Name City State
China 307 Hospital of PLA Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Sinocelltech Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival (OS) up to 3years
Primary Progression-free survival(PFS)evaluated by the Blinded Independent Central Review Committee (BICR) based on RECIST V1.1 up to 3years
Secondary PFS PFS evaluated by investigator based on RECIST V1.1 up to 3years
Secondary PFS PFS evaluated by BICR based on mRECIST. up to 3years
Secondary Objective response rate (ORR) ORR evaluated by BICR based on RECIST V1.1. up to 3years
Secondary ORR ORR evaluated by BICR based on mRECIST. up to 3years
Secondary ORR ORR evaluated by investigator based on RECIST V1.1 up to 3years
Secondary Serum concentration of SCT-I10A and SCT510 up to 3years
Secondary Anti-drug antibody (ADA) up to 3years
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