Health TrialsbyHealthPanel

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

ConditionHepatocellular 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • SHR-8068 + Adebrelimab + Bevacizumab

    Drug

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

  • SHR-8068 Placebo + Adebrelimab Placebo + Bevacizumab Placebo

    Drug

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

  • SHR-8068 Placebo + Adebrelimab + Bevacizumab

    Drug

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

Treatment groups

690 Participants
are divided into 3 treatment groups
Group A: Treatment group AExperimental treatment 1 intervention
Group B: Treatment group BActive comparator 1 intervention
Group C: Treatment group CExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS) assessed by investigator

Time frame
Until progression, assessed up to approximately 2 years.

Secondary outcomes

1

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

Time frame
Until progression, assessed up to approximately 2 years.
2

Overall survival (OS)

Time frame
Until study completion, assessed up to approximately 2 years.
3

Objective response rate (ORR)

Time frame
Until study completion, assessed up to approximately 2 years.
4

Disease control rate (DCR)

Time frame
Until study completion, assessed up to approximately 2 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: