Health Trials

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

ConditionHepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso

About this trial

There'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.

Eligibility criteria

Qualifiers

Be able and willing to provide written informed consent.

Have a life expectancy of at least 3 months.

Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

HCC confirmed by histology/cytology or confirmed by the American Society for the Study of Hepatology (AASLD) clinical diagnostic criteria for hepatocellular carcinoma in patients with cirrhosis.

Disqualifiers

Components confirmed by histology/cytology, such as fibrous layer hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and cholangiocarcinoma.

Except for HCC, the subjects had other malignant tumors within the 5 years prior to enrollment. Subjects with other malignant tumors that have been cured through local treatment are not excluded, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast cancer in situ. If diagnosed with liver cancer or other malignant tumors more than 5 years before administration, pathological or cytological diagnosis of recurrent and metastatic lesions is required.

Tumor volume>50% liver volume; Portal vein cancer thrombus (Vp4), inferior vena cava cancer thrombus.

Tumors invade important organs and blood vessels around them, and researchers have determined that entering the study will cause a higher risk of bleeding.

Trial design

Treatments tested in this trial

  • AK112
  • Cadonilimab
  • AK127
  • AK130
  • Sintilimab Injection
  • Bevacizumab biosimilar

Treatment groups

280 Participants
are divided into 5 treatment groups

Sponsors and collaborators

Akeso

Lead sponsor

Source ClinicalTrials.gov