NCT04560894

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
405

participants targeted

Target at P75+ for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Nov 2020

Typical duration for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

November 11, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

3.4 years

First QC Date

September 17, 2020

Last Update Submit

January 30, 2024

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Overall survival (OS)

    up to 3years

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

    up to 3years

Secondary Outcomes (7)

  • PFS

    up to 3years

  • PFS

    up to 3years

  • Objective response rate (ORR)

    up to 3years

  • ORR

    up to 3years

  • ORR

    up to 3years

  • +2 more secondary outcomes

Study Arms (2)

SCT-I10A+SCT510

EXPERIMENTAL
Drug: SCT-I10ADrug: SCT510

Sorafenib

ACTIVE COMPARATOR
Drug: Sorafenib 200mg

Interventions

SCT-I10ADRUG

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

SCT-I10A+SCT510
SCT510DRUG

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

SCT-I10A+SCT510
Sorafenib 200mgDRUG

Participants receive sorafenib orally，400mg bid

Sorafenib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

307 Hospital of PLA

Beijing, Beijing Municipality, 100071, China

Location

Related Publications (1)

  • Zhao C, Zhang Y, Wang G, Zheng J, Chen W, Lu Z, Zhuang L, Gu S, Han L, Zheng Z, Yu Z, Yang Y, Sun H, Wei X, Cheng Y, Lin H, Zhu B, Wu G, Lei K, Wang W, Wang Y, Chen K, Xu X, Zheng C, Bi Y, Ding S, Zhang J, Li W, Liu H, Wang J, Liu X, Du Y, Cai L, Wang J, Luo Z, Xing B, Shen J, Yang L, Wu J, Jiang O, Peng Z, Liu X, Cao B, Shen L, Xu A, Li A, Chen S, Fu T, Chen J, Jin C, Zhang L, Lv J, Zhang C, Zhang X, Wang Y, Su H, Zhou Q, Gai W, Xie L, Xu J. Finotonlimab (PD-1 inhibitor) plus bevacizumab (bevacizumab biosimilar) as first-tier therapy for late-stage hepatocellular carcinoma: a randomized phase 2/3 trial. Signal Transduct Target Ther. 2025 Aug 6;10(1):249. doi: 10.1038/s41392-025-02333-5.

    PMID: 40769977DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2020

First Posted

September 23, 2020

Study Start

November 11, 2020

Primary Completion

April 1, 2024

Study Completion

September 1, 2024

Last Updated

February 1, 2024

Record last verified: 2024-01

Locations

CN(1)