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

Last updated: March 13, 2026
Sponsor: Akeso
Overall Status: Active - Recruiting

Phase

2

Condition

Carcinoma

Treatment

AK104

TT-00420 (tinengotinib)

AK112

Clinical Study ID

NCT07052253
AK104-223
  • Ages 18-75
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 and ≤ 75 years.

  2. Histologically or cytologically confirmed hepatocellular carcinoma, or meets theclinical diagnostic criteria for hepatocellular carcinoma.

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

  4. For cohorts A and B: No prior systemic anti-cancer treatment for hepatocellularcarcinoma.

  5. At least one measurable lesion according to RECIST v1.1 criteria.

  6. Child-Pugh liver function score ≤7. ECOG performance status of 0 or 1.

  7. Clinically controllable HBV or HCV infection.

  8. Adequate organ and bone marrow function.

Exclusion

Exclusion Criteria:

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

  2. Diagnosed with another malignancy within 3 years.

  3. History of hepatic encephalopathy.

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

  5. Concurrent infection with HBV and HCV.

  6. Presence of central nervous system metastases or meningeal metastases.

  7. Esophageal or gastric variceal bleeding within 6 months. Imaging (CT or MRI) showsextrahepatic metastasis invading major blood vessels or indistinct vascularboundaries, with high bleeding risk assessed by the researcher.

  8. Liver tumor volume exceeding 50% of total liver volume; portal vein main trunk tumorthrombus or tumor thrombus in contralateral main branch of the portal vein, ormesenteric vein tumor thrombus; presence of inferior vena cava thrombus orinvolvement of the heart.

  9. Received topical treatment for liver cancer, any systemic anti-tumor drugs, or otherclinical trial drugs within 4 weeks prior to the first administration.

  10. Unable to swallow, or has severe gastrointestinal disease or gastrointestinaldysfunction. History of intestinal obstruction or intestinal perforation within 6months.

  11. Uncontrolled hypertension, symptomatic heart failure, symptomatic or poorlycontrolled arrhythmia, myocarditis, cardiomyopathy, history of malignantarrhythmias.

  12. Participants with severe bleeding tendencies or coagulation disorders.

  13. Active pulmonary tuberculosis, active syphilis, or history of HIV infection.

  14. Severe infection within 4 weeks prior to the first administration, or receivedsystemic anti-infective treatment within 14 days.

  15. Other conditions with high medical risk or secondary tumor symptoms, which, in thejudgment of the researcher, make the participant unsuitable for participation in thestudy.

Study Design

Total Participants: 100
Treatment Group(s): 3
Primary Treatment: AK104
Phase: 2
Study Start date:
July 18, 2025
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Union Hospital Tongji Medical College Huazhong University of Science And Technology

    Wuhan, China 430000
    China

    Active - Recruiting

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