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Hepatocellular Carcinoma (HCC)Phase 2NCT07052253

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

A Phase 2 study testing TT-00420 (tinengotinib), AK104 and AK112 in people with Hepatocellular Carcinoma (HCC), run by Akeso at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatocellular Carcinoma (HCC)
What is being tested?
TT-00420 (tinengotinib), AK104 and AK112
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
18 Jul 2025to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ting Liu, M.D. contact

(0760)89873999

clinicaltrials@akesobio.com

China1 site, 1 recruiting

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

    Wuhan, China, 430000

    Xiaoping Chen, M.D.

    Xiaoping Chen, M.D.

    Recruiting

Other trials in China

About this study

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.

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

Being tested
TT-00420 (tinengotinib), AK104, AK112
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TT-00420 (tinengotinib)Drug

    oral

  • AK104Drug

    intravenous

  • AK112Drug

    intravenous

Study groups in NCT07052253
Study groupRoleWhat they receive
Cohort 1（Safety Lead-In Phase）ExperimentalAK104 10mg/kg Q3W+TT-00420 10mg PO QD （n=3-6）
Receives: Drug: TT-00420 (tinengotinib); Drug: AK104
Cohort 2（Safety Lead-In Phase）ExperimentalAK112 20mg/kg Q3W + TT-00420 10mg PO QD（n=3-6）
Receives: Drug: TT-00420 (tinengotinib); Drug: AK112
Cohort A（Expansion Cohort Phase）ExperimentalAK104 10mg/kg Q3W + TT-00420 10mg PO QD（n=20-30）
Receives: Drug: TT-00420 (tinengotinib); Drug: AK104
Cohort B（Expansion Cohort Phase）ExperimentalAK112 20mg/kg Q3W + TT-00420 10mg PO QD（n=20-30）
Receives: Drug: TT-00420 (tinengotinib); Drug: AK112
Cohort C（Expansion Cohort Phase）ExperimentalTT-00420 10mg PO QD（n=20-30）
Receives: Drug: TT-00420 (tinengotinib)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    assessed by investigator per RECIST v1.1

    Measured: Up to 2 years

Secondary outcomes (6)

  1. Progression-free survival (PFS)

    assessed by investigator per RECIST v1.1

    Measured: up to 2 years

  2. Disease control rate(DCR)

    assessed by investigator per RECIST v1.1

    Measured: Up to 2 years

  3. Duration of Response (DOR)

    assessed by investigator per RECIST v1.1

    Measured: Up to 2 years

  4. Time to Response (TTR)

    assessed by investigator per RECIST v1.1

    Measured: Up to 2 years

  5. Time to Progression (TTP)

    assessed by investigator per RECIST v1.1

    Measured: Up to 2 years

  6. Overall Survival(OS)

    OS is defined as the time from randomization or first dosing to death due to any cause.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2025
  2. Study start18 Jul 2025
  3. Primary completion10 May 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07052253
Sponsor's protocol ID
AK104-223
Status last verified
Mar 2026
First submitted
26 Jun 2025
Last updated
16 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TT-00420 (tinengotinib), AK104 and AK112 in people with Hepatocellular Carcinoma (HCC), run by Akeso at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ting Liu, M.D. ((0760)89873999, clinicaltrials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07052253.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.

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