NCT07691762

Brief Summary

This is a multicenter, Phase 3 clinical trial to evaluate the efficacy and safety of SHR-8068, Adebrelimab, and Bevacizumab and TACE versus Placebo with TACE in incurable hepatocellular carcinoma. Participants will continue treatment until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
690

participants targeted

Target at P75+ for phase_3 hepatocellular-carcinoma

Timeline
57mo left

Started Jul 2026

Typical duration for phase_3 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress2%
Jul 2026Apr 2031

Study Start

First participant enrolled

July 1, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2031

Last Updated

July 9, 2026

Status Verified

July 1, 2026

Enrollment Period

4.8 years

First QC Date

July 2, 2026

Last Update Submit

July 2, 2026

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival (PFS) assessed by investigator

    Until progression, assessed up to approximately 2 years

Secondary Outcomes (9)

  • Progression-free survival (PFS) assessed by Blinded Independ Review Committee( BIRC)

    Until progression, assessed up to approximately 2 years

  • Overall survival (OS)

    Until study completion, assessed up to approximately 2 years

  • Objective response rate (ORR)

    Until study completion,assessed up to approximately 2 years

  • Disease control rate (DCR)

    Until study completion,assessed up to approximately 2 years

  • Duration of objective tumor response (DoR)

    Until study completion,assessed up to approximately 2 years

  • +4 more secondary outcomes

Study Arms (3)

Treatment group A

EXPERIMENTAL

SHR-8068+ Adebrelimab+ Bevacizumab +Transarterial Chemoembolization(TACE)

Drug: SHR-8068+ Adebrelimab+ Bevacizumab

Treatment group B

ACTIVE COMPARATOR

SHR-8068 Placebo+ Adebrelimab Placebo+ Bevacizumab Placebo+Transarterial Chemoembolization(TACE)

Drug: SHR-8068 Placebo+ Adebrelimab Placebo+ Bevacizumab Placebo

Treatment group C

EXPERIMENTAL

SHR-8068 Placebo+Adebrelimab+ Bevacizumab +Transarterial Chemoembolization(TACE)

Drug: SHR-8068 Placebo +Adebrelimab+ Bevacizumab

Interventions

SHR-8068+ Adebrelimab+ BevacizumabDRUG

SHR-8068+ Adebrelimab+ Bevacizumab,intravenous infusion，Transarterial Chemoembolization(TACE)

Treatment group A
SHR-8068 Placebo+ Adebrelimab Placebo+ Bevacizumab PlaceboDRUG

SHR-8068 Placebo+ Adebrelimab Placebo+ Bevacizumab Placebo,intravenous infusion，Transarterial Chemoembolization(TACE)

Treatment group B
SHR-8068 Placebo +Adebrelimab+ BevacizumabDRUG

SHR-8068 Placebo +Adebrelimab+ Bevacizumab,intravenous infusion，Transarterial Chemoembolization(TACE)

Treatment group C

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-75 years old, male or female;
  • Diagnosis confirmed HCC by pathologically or clinically;
  • At least one measurable lesion;
  • Child-Pugh liver function grade A;
  • ECOG-PS score: 0 or 1;
  • Eligible for TACE treatment as assessed by the investigator;
  • Participants with HBV or HCV infection must be on and remain on standard antiviral therapy throughout the study period;
  • Consent to contraception

You may not qualify if:

  • Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma or mixed cholangiocarcinoma / hepatocellular carcinoma; Participants with other malignancies currently or within the past 5 years;
  • Participants with any active, known or suspected autoimmune disorder;
  • Participants with hypertension which cannot be well controlled by antihypertensives;
  • Uncontrolled cardiac diseases or symptoms;
  • Participants with hepatic encephalopathy;
  • Prior esophageal and/or gastric varices bleeding within 6 months prior to initiation of study treatment
  • History of gastrointestinal perforation and/or fistula,
  • Participants with other potential factors that may affect the study results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital，Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Junqin Yang

CONTACT

+86-0518-82342973junqin.yang@hengrui.com

Huan Wang

CONTACT

+86-0518-82342973huan.wang.hw396@hengrui.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2026

First Posted

July 9, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

April 1, 2031

Study Completion (Estimated)

April 1, 2031

Last Updated

July 9, 2026

Record last verified: 2026-07

Locations

CN(1)