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Recruiting NCT07052253

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

Phase II Interventional Hepatocellular Carcinoma (HCC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TT-00420 (tinengotinib), AK104, AK112.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma (HCC). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

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

Primary outcome measures

  • Objective Response Rate (ORR) [Time frame: Up to 2 years]
Secondary outcome measures (6)
  • Progression-free survival (PFS) [Time frame: up to 2 years]
  • Disease control rate(DCR) [Time frame: Up to 2 years]
  • Duration of Response (DOR) [Time frame: Up to 2 years]
  • Time to Response (TTR) [Time frame: Up to 2 years]
  • Time to Progression (TTP) [Time frame: Up to 2 years]
  • Overall Survival(OS) [Time frame: Up to 2 years]

Eligibility criteria

Inclusion criteria

  • 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.
  • At least one measurable lesion according to RECIST v1.1 criteria.
  • Child-Pugh liver function score ≤7. ECOG performance status of 0 or 1.
  • Clinically controllable HBV or HCV infection.
  • Adequate organ and bone marrow function.

Exclusion criteria

  • 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.
  • Concurrent infection with HBV and HCV.
  • Presence of central nervous system metastases or meningeal metastases.
  • Esophageal or gastric variceal bleeding within 6 months. Imaging (CT or MRI) shows extrahepatic metastasis invading major blood vessels or indistinct vascular boundaries, with high bleeding risk assessed by the researcher.
  • Liver tumor volume exceeding 50% of total liver volume; portal vein main trunk tumor thrombus or tumor thrombus in contralateral main branch of the portal vein, or mesenteric vein tumor thrombus; presence of inferior vena cava thrombus or involvement of the heart.
  • Received topical treatment for liver cancer, any systemic anti-tumor drugs, or other clinical trial drugs within 4 weeks prior to the first administration.
  • Unable to swallow, or has severe gastrointestinal disease or gastrointestinal dysfunction. History of intestinal obstruction or intestinal perforation within 6 months.
  • Uncontrolled hypertension, symptomatic heart failure, symptomatic or poorly controlled arrhythmia, myocarditis, cardiomyopathy, history of malignant arrhythmias.
  • Participants with severe bleeding tendencies or coagulation disorders.
  • Active pulmonary tuberculosis, active syphilis, or history of HIV infection.
  • Severe infection within 4 weeks prior to the first administration, or received systemic anti-infective treatment within 14 days.
  • Other conditions with high medical risk or secondary tumor symptoms, which, in the judgment of the researcher, make the participant unsuitable for participation in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Union Hospital Tongji Medical College Huazhong University of Science And Technology — Wuhan

Identifiers

NCT: NCT07052253 · AK104-223

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗