New cocktail of drugs takes on tough liver cancer
NCT ID NCT07052253
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing a combination of two immunotherapy drugs (AK104 and AK112) plus a targeted pill (TT-00420) in 100 people with advanced hepatocellular carcinoma that cannot be treated with local therapies. The main goal is to see how many patients' tumors shrink. Participants must not have had prior systemic cancer treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AK104, AK112 (immunotherapy drugs) and TT-00420 (tinengotinib, a targeted pill)
- What this could lead to
- If successful, this combination could offer a new treatment option for people with advanced liver cancer who have not had prior systemic therapy.
- What could go wrong
- This is an early-phase trial with only 100 participants, so results may not apply to everyone. The combination may cause significant side effects or fail to shrink tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 and ≤ 75 years. 2. Histologically or cytologically confirmed hepatocellular carcinoma, or meets the clinical diagnostic criteria for hepatocellular carcinoma. 3. Barcelona Clinic Liver Cancer (BCLC) stage C; or stage B and assessed by the investigator as unsuitable for curative topical treatment. 4. For cohorts A and B: No prior systemic anti-cancer treatment for hepatocellular carcinoma. 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 Criteria: 1. Previous histologically or cytologically confirmed fibrolamellar hepatocellular carcinoma, 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 pleural effusion 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) shows extrahepatic metastasis invading major blood vessels or indistinct vascular boundaries, with high bleeding risk assessed by the researcher. 8. 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. 9. Received topical treatment for liver cancer, any systemic anti-tumor drugs, or other clinical trial drugs within 4 weeks prior to the first administration. 10. Unable to swallow, or has severe gastrointestinal disease or gastrointestinal dysfunction. History of intestinal obstruction or intestinal perforation within 6 months. 11. Uncontrolled hypertension, symptomatic heart failure, symptomatic or poorly controlled arrhythmia, myocarditis, cardiomyopathy, history of malignant arrhythmias. 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 received systemic anti-infective treatment within 14 days. 15. 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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Union Hospital Tongji Medical College Huazhong University of Science And Technology
RECRUITINGWuhan, China, 430000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Triple drug combo targets advanced liver cancer in new trial
- Can two immunotherapy drugs make liver tumors more vulnerable to surgery?
- Saline barrier lets heat target liver tumors near the diaphragm
- Can a new PET tracer spot liver cancer more clearly?
- Can a smart drug starve liver tumors without harming healthy tissue?