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A Trial of SHR-8068 Combined With Adebrelimab and Apatinib in Perioperative Treatment of Resectable Hepatocellular Carcinoma

ConditionResectable Hepatocellular Carcinoma With Intermediate or High Recurrence Risk
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

About this trial

This study is conducted to evaluate the efficacy and safety of SHR-8068 combined with Adebrelimab and Apatinib compared with Adebrelimab combined with Apatinib in perioperative treatment of resectable hepatocellular carcinoma with intermediate or high recurrence risk.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects who voluntarily participate in this study and sign the informed consent form.

Age from 18 to 70, male or female.

Histopathologically/cytologically confirmed or clinically diagnosed with hepatocellular carcinoma (HCC).

At least one measurable lesion based on RECIST v1.1.

Disqualifiers

Known intrahepatic cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, mixed hepatocellular carcinoma, or fibrolamellar hepatocellular carcinoma.

Other malignancies within the past 5 years or concurrent malignancy.

Known history of severe hypersensitivity reaction to any monoclonal antibody.

Previous or current central nervous system metastases.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-8068 Injection

    Drug

    SHR-8068 injection.

  • Adebrelimab Injection

    Drug

    Adebrelimab injection.

  • Apatinib Mesylate Tablets

    Drug

    Apatinib mesylate tablets.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: SHR-8068 + Adebrelimab + Apatinib GroupExperimental treatment 3 interventions
Group B: Adebrelimab + Apatinib GroupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Major pathological response (MPR (70%)) rate.

MPR (70%) is defined as residual viable tumor cells \<= 30% in the tumor bed.

Time frame
After surgery, approximately 3 months.

Secondary outcomes

1

Event-free survival (EFS).

Time frame
From randomization to event, approximately 2 years.
2

12-month and 24-month Event-free survival (EFS) rate.

Time frame
From randomization to event, approximately 2 years.
3

R0 resection rate.

Time frame
After surgery, approximately 3 months.
4

Safety endpoints, including adverse events (AEs) and serious adverse events (SAEs) by NCI-CTCAE v6.0.

Time frame
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: