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
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
Treatments tested in this trial
- TT-00420 (tinengotinib)
- AK104
- AK112
Treatment groups
100 Participants
are divided into 5 treatment groupsSponsors and collaborators
Akeso
Lead sponsor
TransThera Sciences (Nanjing), Inc.
Collaborator
Source ClinicalTrials.gov