Liver cancer breakthrough: surgery or pills after shrinkage?
NCT ID NCT07206511
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at patients with advanced liver cancer that cannot be removed by surgery at first. They receive a combination of treatments—chemotherapy directly into the liver, anti-angiogenic drugs, and immunotherapy—to shrink the tumor. If the tumor shrinks enough to become removable or disappears completely on scans, patients either have surgery or continue medication. The goal is to see which approach leads to better long-term outcomes, such as survival and freedom from cancer recurrence.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- combination of TACE/HAIC, anti-angiogenic agents, and immune checkpoint inhibitors
- What this could lead to
- If successful, this could help doctors decide whether surgery or continued medication is better for patients with advanced liver cancer that shrinks after initial treatment.
- What could go wrong
- This is an observational study, not a randomized trial, so results may be less definitive. The findings may not apply to all liver cancer patients, and both treatments carry risks like infection or drug side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 278 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Participants are adults (18-75 years) with initially unresectable hepatocellular carcinoma (uHCC) diagnosed by histology/cytology or according to AASLD criteria and Chinese national guidelines. These patients have received conversion therapy consisting of transarterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC) combined with anti-angiogenic agents and immune checkpoint inhibitors (ICIs). After conversion therapy, participants have achieved radiological complete response (rCR) or reached resectability criteria and then either undergo curative liver resection or continue systemic therapy. Eligible patients must have Child-Pugh class A or B liver function and ECOG performance status 0-1.
- 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. Signed written informed consent. 2. Age 18-75 years. 3. Hepatocellular carcinoma (HCC) confirmed by histology/cytology or diagnosed according to the AASLD criteria. 4. Initially unresectable HCC (uHCC), defined according to the Chinese Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 edition) and the Chinese Expert Consensus on Conversion and Perioperative Therapy for Primary Liver Cancer (2024 edition): HCC considered unsafe for curative resection due to inability to ensure both oncological completeness (R0 resection) and functional hepatic reserve (adequate future liver remnant with good vascular supply and biliary drainage to maintain postoperative liver function and minimize morbidity and mortality). Mainly includes CNLC stage Ib-IIIa or potentially resectable cases. Some stage Ia patients may also be considered uHCC if the tumor is adjacent to major intrahepatic vessels or involves the first/second hepatic hilum making R0 resection infeasible, or if severe cirrhosis increases risk of postoperative liver failure and complications; these can be considered after successful conversion and supportive treatment. 5. No prior systemic therapy before conversion treatment. 6. Conversion therapy regimen must include TACE or HAIC plus anti-angiogenic agents and immune checkpoint inhibitors (ICIs). 7. Anti-angiogenic agents may include lenvatinib, sorafenib, apatinib, donafenib, anlotinib, bevacizumab. 8. ICIs may include pembrolizumab, atezolizumab, nivolumab, sintilimab, tislelizumab, toripalimab, penpulimab, cadonilimab, KN-046. 9. After conversion therapy, hepatic lesions achieve radiological complete response (rCR) by mRECIST criteria on contrast-enhanced CT or MRI, or are assessed to have reached resectability criteria (eligible for curative hepatectomy or downstaging enabling safe surgery). 10. After achieving rCR or resectability, patients must have received either liver resection or continued systemic therapy with scheduled follow-up. 11. Child-Pugh class A or B liver function. 12. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1. Exclusion Criteria: 1. Presence of another primary malignancy in other organs. 2. History of other malignancies. 3. Recurrent HCC occurring \<2 years after previous curative surgery or adjuvant therapy. 4. Received treatments other than TACE or HAIC plus anti-angiogenic agents and ICIs during the conversion phase. 5. Received treatments during postoperative or maintenance systemic therapy that differ from the initial conversion regimen. 6. Severe organ dysfunction. 7. Incomplete radiological assessment data after treatment. 8. Child-Pugh class C liver function. 9. Pregnant or breastfeeding women. 10. Patients undergoing only functional future liver remnant (FLR) hypertrophy procedures (e.g., ALPPS or PVE) for insufficient FLR without other criteria for uHCC conversion.
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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 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.