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

• Sponsor: Sinocelltech Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04560894
• Collaborator: (none)
• Enrollment: 621
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 45.7
• Patients Per Site Per Month: 13.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Drug: SCT-I10A; Drug: SCT510; Drug: Sorafenib 200mg	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated 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: Nov 11, 2020
• Anticipated Primary Completion Date: Apr 1, 2024
• Anticipated Study Completion Date: Sep 1, 2024

Arms and Interventions

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

Primary Outcome Measures

1. Overall survival (OS) [up to 3years]

2. Progression-free survival(PFS)evaluated by the Blinded Independent Central Review Committee (BICR) based on RECIST V1.1 [up to 3years]

Secondary Outcome Measures

1. PFS [up to 3years]

   PFS evaluated by investigator based on RECIST V1.1

2. PFS [up to 3years]

   PFS evaluated by BICR based on mRECIST.

3. Objective response rate (ORR) [up to 3years]

   ORR evaluated by BICR based on RECIST V1.1.

4. ORR [up to 3years]

   ORR evaluated by BICR based on mRECIST.

5. ORR [up to 3years]

   ORR evaluated by investigator based on RECIST V1.1

6. Serum concentration of SCT-I10A and SCT510 [up to 3years]

7. Anti-drug antibody (ADA) [up to 3years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	307 Hospital of PLA	Beijing	Beijing	China	100071

Sponsors and Collaborators

• Sinocelltech Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sinocelltech Ltd.
• ClinicalTrials.gov Identifier: NCT04560894
• Other Study ID Numbers: SCT-I10A-C301
• First Posted: Sep 23, 2020
• Last Update Posted: Nov 13, 2020
• Last Verified: Sep 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Sorafenib

Study Results

No Results Posted as of Nov 13, 2020