A Study of TACE in Combination With SHR-8068, Adebrelimab, and Bevacizumab Versus TACE in Participants With Incurable Hepatocellular Carcinoma

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • SHR-8068+ Adebrelimab+ Bevacizumab
  • SHR-8068 Placebo+ Adebrelimab Placebo+ Bevacizumab Placebo
  • SHR-8068 Placebo +Adebrelimab+ Bevacizumab

Treatment groups

690 Participants
are divided into 3 treatment groups