A Study of TACE in Combination With SHR-8068, Adebrelimab, and Bevacizumab Versus TACE in Participants With Incurable Hepatocellular Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-8068+ Adebrelimab+ Bevacizumab, SHR-8068 Placebo+ Adebrelimab Placebo+ Bevacizumab Placebo, SHR-8068 Placebo +Adebrelimab+ Bevacizumab.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase III, Randomized, Double-blind, Multicenter Study of SHR-8068 and Adebrelimab Plus Bevacizumab in Combination With TACE in Participants With Incurable Hepatocellular Carcinoma
Overview
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.
Interventions
- Drug SHR-8068+ Adebrelimab+ Bevacizumab
SHR-8068+ Adebrelimab+ Bevacizumab,intravenous infusion，Transarterial Chemoembolization(TACE) - Drug SHR-8068 Placebo+ Adebrelimab Placebo+ Bevacizumab Placebo
SHR-8068 Placebo+ Adebrelimab Placebo+ Bevacizumab Placebo,intravenous infusion，Transarterial Chemoembolization(TACE) - Drug SHR-8068 Placebo +Adebrelimab+ Bevacizumab
SHR-8068 Placebo +Adebrelimab+ Bevacizumab,intravenous infusion，Transarterial Chemoembolization(TACE)
Primary outcome measures
- Progression-free survival (PFS) assessed by investigator [Time frame: Until progression, assessed up to approximately 2 years]
Secondary outcome measures (9)
- Progression-free survival (PFS) assessed by Blinded Independ Review Committee( BIRC) [Time frame: Until progression, assessed up to approximately 2 years]
- Overall survival (OS) [Time frame: Until study completion, assessed up to approximately 2 years]
- Objective response rate (ORR) [Time frame: Until study completion,assessed up to approximately 2 years]
- Disease control rate (DCR) [Time frame: Until study completion,assessed up to approximately 2 years]
- Duration of objective tumor response (DoR) [Time frame: Until study completion,assessed up to approximately 2 years]
- Adverse events (AEs) [Time frame: Until study completion,assessed up to approximately 2years]
- Serious adverse events (SAEs) [Time frame: Until study completion,assessed up to approximately 3 years]
- Pharmacokinetics parameters of SHR-8068 、Adebrelimab:serum concentration [Time frame: Approximately 90 days post-last dose]
- Immunogenicity indicators of SHR-8068 、Adebrelimab: drug resistant antibody (ADA) and neutralizing antibody (NAb) [Time frame: Approximately 90 days post-last dose]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhongshan Hospital，Fudan University — Shanghai
Identifiers
NCT: NCT07691762 · SHR-8068-305