Hepatocellular Carcinoma
Conditions
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.
Interventions
DRUGSHR-8068+ Adebrelimab+ Bevacizumab
SHR-8068+ Adebrelimab+ Bevacizumab,intravenous infusion，Transarterial Chemoembolization(TACE)
DRUGSHR-8068 Placebo+ Adebrelimab Placebo+ Bevacizumab Placebo
SHR-8068 Placebo+ Adebrelimab Placebo+ Bevacizumab Placebo,intravenous infusion，Transarterial Chemoembolization(TACE)
DRUGSHR-8068 Placebo +Adebrelimab+ Bevacizumab
SHR-8068 Placebo +Adebrelimab+ Bevacizumab,intravenous infusion，Transarterial Chemoembolization(TACE)
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-75 years old, male or female; 2. Diagnosis confirmed HCC by pathologically or clinically; 3. At least one measurable lesion; 4. Child-Pugh liver function grade A; 5. ECOG-PS score: 0 or 1; 6. Eligible for TACE treatment as assessed by the investigator; 7. Participants with HBV or HCV infection must be on and remain on standard antiviral therapy throughout the study period; 8. Consent to contraception
Exclusion criteria
1. Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma or mixed cholangiocarcinoma / hepatocellular carcinoma; Participants with other malignancies currently or within the past 5 years; 2. Participants with any active, known or suspected autoimmune disorder; 3. Participants with hypertension which cannot be well controlled by antihypertensives; 4. Uncontrolled cardiac diseases or symptoms; 5. Participants with hepatic encephalopathy; 6. Prior esophageal and/or gastric varices bleeding within 6 months prior to initiation of study treatment 7. History of gastrointestinal perforation and/or fistula, 8. Participants with other potential factors that may affect the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) assessed by investigator | Until progression, assessed up to approximately 2 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Adverse events (AEs) | Until study completion,assessed up to approximately 2years |
| Serious adverse events (SAEs) | Until study completion,assessed up to approximately 3 years |
| Pharmacokinetics parameters of SHR-8068 、Adebrelimab:serum concentration | Approximately 90 days post-last dose |
| Immunogenicity indicators of SHR-8068 、Adebrelimab: drug resistant antibody (ADA) and neutralizing antibody (NAb) | Approximately 90 days post-last dose |
Countries
China
Contacts
CONTACTJunqin Yang
CONTACTHuan Wang
Outcome results
None listed