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OncoMatch/Clinical Trials/NCT06530251

A Study of AK112 in Patients With Advanced Hepatocellular Carcinoma (HCC)

Is NCT06530251 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for hepatocellular carcinoma.

Phase 1/2RecruitingAkesoNCT06530251Data as of May 2026

Treatment: AK112 · Cadonilimab · AK127 · AK130 · Sintilimab · Bevacizumab biosimilarThere're 2 parts in this interventional study: 1. The goal of phase Ib trial is to evaluate the safety and tolerability of AK112 in combination therapies for the purpose of observing the incidence of dose limit toxicity (DLT) as well as the confirmation of maximum tolerable dose (MTD) in the treatment of advanced hepatocellular carcinoma (HCC), so as to determine the recommended phase 2 dose (RP2D) in the second part of the trial. 2. The goal of phase II trial is to evaluate the safety and efficacy of AK112 in combination therapy or monotherapy in the treatment of HCC compared to the combination of Sintilimab and Bevacizumab biosimilar.

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Disease stage

Required: Stage BCLC STAGE B, BCLC STAGE C (BCLC)

Grade: Child Pugh Grade A (Child Pugh)

Barcelona Clinical Liver Cancer (BCLC) stage B or C. Liver function grading Child Pugh Grade A.

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 2 prior lines

Cannot have received: immunotherapy

Previously received immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy, and any other treatments targeting the immune mechanisms of tumors.

Cannot have received: local treatment for the liver

Exception: allowed if >4 weeks prior to first administration

Received local treatment for the liver within 4 weeks prior to the first administration

Cannot have received: palliative radiotherapy for non liver patients

Exception: allowed if >2 weeks prior to initial administration

Received palliative radiotherapy for non liver patients within 2 weeks prior to initial administration

Lab requirements

Blood counts

adequate organ function

Kidney function

adequate organ function

Liver function

Child Pugh Grade A

Has adequate organ function. Liver function grading Child Pugh Grade A.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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