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

Primary Purpose

Hepatocellular Carcinoma

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

SCT-I10A

SCT510

Sorafenib 200mg

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

307 Hospital of PLARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SCT-I10A+SCT510

Sorafenib

Arm Description

Outcomes

Primary Outcome Measures

Overall survival (OS)

Progression-free survival(PFS)evaluated by the Blinded Independent Central Review Committee (BICR) based on RECIST V1.1

Secondary Outcome Measures

PFS

PFS evaluated by investigator based on RECIST V1.1

PFS

PFS evaluated by BICR based on mRECIST.

Objective response rate (ORR)

ORR evaluated by BICR based on RECIST V1.1.

ORR

ORR evaluated by BICR based on mRECIST.

ORR

ORR evaluated by investigator based on RECIST V1.1

Serum concentration of SCT-I10A and SCT510

Anti-drug antibody (ADA)

Full Information

NCT ID

NCT04560894

First Posted

September 17, 2020

Last Updated

November 11, 2020

Sponsor

Sinocelltech Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04560894

Brief Title

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

Acronym

HCC

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Recruiting

Study Start Date

November 11, 2020 (Actual)

Primary Completion Date

April 2024 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sinocelltech Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

621 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SCT-I10A+SCT510

Arm Type

Experimental

Arm Title

Sorafenib

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

SCT-I10A

Intervention Description

Participants receive SCT-I10A intravenously，200mg，d1，Q3w

Intervention Type

Drug

Intervention Name(s)

SCT510

Intervention Description

Participants receive SCT510 intravenously，15mg/kg，d1，Q3w

Intervention Type

Drug

Intervention Name(s)

Sorafenib 200mg

Intervention Description

Participants receive sorafenib orally，400mg bid

Primary Outcome Measure Information:

Title

Overall survival (OS)

Time Frame

up to 3years

Title

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 Measure Information:

Title

PFS

Description

PFS evaluated by investigator based on RECIST V1.1

Time Frame

up to 3years

Title

PFS

Description

PFS evaluated by BICR based on mRECIST.

Time Frame

up to 3years

Title

Objective response rate (ORR)

Description

ORR evaluated by BICR based on RECIST V1.1.

Time Frame

up to 3years

Title

ORR

Description

ORR evaluated by BICR based on mRECIST.

Time Frame

up to 3years

Title

ORR

Description

ORR evaluated by investigator based on RECIST V1.1

Time Frame

up to 3years

Title

Serum concentration of SCT-I10A and SCT510

Time Frame

up to 3years

Title

Anti-drug antibody (ADA)

Time Frame

up to 3years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

jianming xu, MD

Phone

+8613910866712

jmxu2003@163.com

Facility Information:

Facility Name

307 Hospital of PLA

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100071

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

jianming xu, MD

Phone

+8613910866712

jmxu2003@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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