Adjuvant Adebrelimab Plus Apatinib for Participants With HCC at High-risk of Recurrence After Curative Resection

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorQilu Hospital of Shandong University

About this trial

This is a single-center, single-arm, open-label clinical study to evaluate the efficacy and safety of Adebrelimab plus Apatinib as adjuvant therapy in hepatocellular carcinoma (HCC) participants who are at high risk of recurrence after curative resection.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily participate in this study and sign an informed consent form.

Participants diagnosed with HCC through pathological histology/cytology or clinically diagnosed with HCC according to the Diagnosis and Treatment Guidelines for Primary Liver Cancer (2024 Edition).

Within 4-12 weeks prior to enrollment, radical resection surgery was performed.

Complete recovery from surgical resection within 4 weeks prior to enrollment.

Disqualifiers

Known hepatobiliary carcinoma, sarcoma like hepatocellular carcinoma, combined hepatocellular-cholangiocarcinoma,and fibrous layer cell carcinoma; Within 5 years or simultaneously suffering from other active malignant tumors other than hepatocellular carcinoma (excluding cured skin basal cell carcinoma and cervical carcinoma in situ).

There are uncontrollable extrahepatic metastases, such as lung and brain metastases (EHS).

Previously received local treatment, including therapeutic TACE, transarterial embolization (TAE), hepatic artery infusion chemotherapy (HAIC), transarterial radiation embolization (TARE), etc.

Participants who are preparing to undergo or have previously received organ or allogeneic bone marrow transplantation.

Trial design

Design model

Single group

Treatments tested in this trial

  • Adebrelimab + Apatinib

    Drug

    the first 6 months or 8 cycles: Adebrelimab 1200 mg, every 3 weeks; Apatinib 250 mg/day Maintenance phase: Adebrelimab 1200 mg, every 3 weeks, Maximum maintenance up to 2 years

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Adebrelimab + ApatinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

RFS Rate at 12 and 24 Months

Recurrence-free survival rate at 12 and 24 Months

Time frame
up to 24 months

Secondary outcomes

1

overall survival

Defined as the time from enrollment to death from any cause

Time frame
3 years
2

Time to Recurrence

The time interval between liver resection and diagnosis of HCC recurrence

Time frame
up to 3 years
3

recurrence-free survival

Ratio of participants from first treatment to disease recurrence

Time frame
up to 3 years

Other outcomes

Sponsors and contacts

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