Liver cancer breakthrough? study tests surgery vs. drug maintenance after successful initial therapy
NCT ID NCT07410715
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at 100 liver cancer patients whose tumors shrank or disappeared after initial therapy. It compares two follow-up options: surgery to remove any remaining cancer, or continuing medication (maintenance therapy). The goal is to see which approach better prevents the cancer from coming back and helps patients live longer. Researchers will track outcomes like recurrence and survival over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PD-1/PD-L1 inhibitor ± tyrosine kinase inhibitor (TKI)
- What this could lead to
- If successful, this study could show whether surgery or continued medication is better for liver cancer patients who improved after initial therapy, guiding future treatment decisions.
- What could go wrong
- This is a non-randomized study with only 100 participants, so results may not apply to all patients. The best approach may depend on individual factors not fully captured here.
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.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
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
Patients with hepatocellular carcinoma (HCC) who achieve complete response (CR) or partial response (PR) following conversion therapy and are deemed eligible for radical hepatectomy (R0 resection) by the multidisciplinary team (MDT) at participating centers.
- Ages
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18 to 80 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. Aged 18-80 years. 2. Diagnosed with locally advanced, metastatic, and/or initially unresectable hepatocellular carcinoma (uHCC) via histology/cytology or clinical criteria (AASLD standards for cirrhotic patients; histopathological confirmation required for non-cirrhotic patients). 3. Previously judged unresectable or inappropriate for resection by MDT during initial diagnosis or disease course, with at least one evaluable lesion per RECIST v1.1. 4. Completed conversion therapy \[systemic therapy (PD-1/PD-L1 ± TKI) ± local therapy (TACE/HAIC/radiation/ablation, etc.)\], achieved CR or PR (primarily assessed by mRECIST, with concurrent RECIST v1.1 documentation), and confirmed via re-evaluation with the same imaging modality ≥4 weeks later. 5. Meets necessary conditions for resection: Child-Pugh Class A liver function, ICG R15 \<30%, and future liver remnant (FLR) accounting for ≥40% of standard liver volume (SLV) in patients with chronic liver disease, hepatic parenchymal injury, or cirrhosis, or ≥30% in patients without liver fibrosis or cirrhosis. 6. For patients with previous portal vein/hepatic vein/inferior vena cava tumor thrombus (without atrial tumor thrombus), enrollment is permitted only if the thrombus has significantly regressed after conversion therapy, MDT confirms feasibility of R0 resection, and risks are acceptable. 7. ECOG performance status 0-1. 8. Adequate organ and bone marrow function, as evidenced by: hemoglobin ≥90g/L; absolute neutrophil count ≥1.5×10⁹/L; platelets ≥60×10⁹/L; total bilirubin ≤1.5×upper limit of normal (ULN); AST, ALT, and ALP ≤2.5×ULN; serum creatinine ≤1.5×ULN or estimated creatinine clearance ≥50ml/min (Cockcroft-Gault formula); urine protein \<(++) or 24-hour urine protein \<1.0g. 9. Normal coagulation function without active bleeding: INR ≤1.5×ULN; APTT ≤1.5×ULN. 10. For patients with active hepatitis B virus (HBV) infection: those already receiving anti-HBV therapy (per local standard treatment) must agree to continue during the study; those not receiving anti-HBV therapy must initiate treatment (per local standard treatment) during screening and agree to continue throughout the study. 11. For patients with HCV infection: excluded if HCV RNA is detectable. 12. No pregnancy or pregnancy plans: fertile females must have a negative urine/serum pregnancy test within 7 days before first dosing and agree to use effective contraception during the study and for 120 days after last dosing; non-sterilized males must agree to use effective contraception during the study and for 120 days after last dosing. Exclusion Criteria: 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma-HCC. 2. Extrahepatic metastasis confirmed by chest, abdominal, and pelvic CT and/or MRI. 3. Inability to achieve R0 resection. 4. Previous liver transplantation or on the liver transplantation waiting list. 5. Decompensated cirrhosis (persistent or refractory ascites, hepatic encephalopathy, progressive jaundice, etc.); Child-Pugh Class B with score ≥8 or Class C; ALBI Grade 3. 6. Significant and uncontrollable portal hypertension (e.g., markedly elevated HVPG with recurrent variceal bleeding, refractory ascites). 7. Active gastrointestinal bleeding within the past 4 weeks or uncorrectable coagulation disorders. 8. Active infection/sepsis or unresolved Grade ≥2 immune-related adverse events (irAEs). 9. Severe cardiopulmonary/renal insufficiency (e.g., NYHA Class III-IV, recent myocardial infarction/stroke, dialysis dependency). 10. Pregnancy or lactation. 11. Other active malignant tumors within the past 5 years (exceptions for low-risk tumors such as basal cell carcinoma of the skin or carcinoma in situ of the cervix). 12. Inability to undergo standardized imaging assessments (multiphase contrast-enhanced CT/MRI) or poor compliance.
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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.
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