A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC.

ConditionHepatocellular Carcinoma (HCC)

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorAkeso

About this trial

An Open-label, Multicenter, Phase II Clinical Study of AK104/AK112 in Combination with TT-00420 Tablet in Patients with Advanced Hepatocellular Carcinoma(HCC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 and ≤ 75 years.

Histologically or cytologically confirmed hepatocellular carcinoma, or meets the clinical diagnostic criteria for hepatocellular carcinoma.

Barcelona Clinic Liver Cancer (BCLC) stage C; or stage B and assessed by the investigator as unsuitable for curative topical treatment.

For cohorts A and B: No prior systemic anti-cancer treatment for hepatocellular carcinoma.

Disqualifiers

Previous histologically or cytologically confirmed fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc.

Diagnosed with another malignancy within 3 years.

History of hepatic encephalopathy.

Presence of clinically significant pericardial effusion; symptomatic pleural effusion requiring drainage or moderate to severe ascites uncontrolled by diuretics.

Trial design

Design model

Parallel

Treatments tested in this trial

TT-00420 (tinengotinib)
Drug
oral
AK104
Drug
intravenous
AK112
Drug
intravenous

Treatment groups

100 Participants

are divided into 5 treatment groups

Group A: Cohort 1（Safety Lead-In Phase）Experimental treatment 2 interventions

Group B: Cohort 2（Safety Lead-In Phase）Experimental treatment 2 interventions

Group C: Cohort A（Expansion Cohort Phase）Experimental treatment 2 interventions

Group D: Cohort B（Expansion Cohort Phase）Experimental treatment 2 interventions

Group E: Cohort C（Expansion Cohort Phase）Experimental treatment 1 intervention