Liver cancer patients get targeted chemo after surgery to stop return
NCT ID NCT07337421
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving a specific chemotherapy cocktail (mFOLFOX) directly into the liver artery after surgery can prevent liver cancer from coming back in patients at high risk. About 30 adults who had their liver cancer removed will receive up to two rounds of this infusion. Researchers will track how long patients stay cancer-free and monitor side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mFOLFOX (oxaliplatin, leucovorin calcium, and 5-fluorouracil) given directly into the liver artery
- What this could lead to
- If it works, this could offer a way to lower the chance of liver cancer coming back after surgery for patients at high risk.
- What could go wrong
- This is a small, early-phase trial with only 30 participants and no comparison group, so results may not apply widely. The chemotherapy can cause side effects like nerve damage, low blood counts, and digestive issues.
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 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Dec 2027
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.
- 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 years and ≤75 years. 2. Histologically/cytologically confirmed hepatocellular carcinoma (HCC) (fibrotic HCC and mixed HCC/biliary carcinoma subtypes were excluded from inclusion criteria), with no prior treatment for HCC (including but not limited to chemotherapy, targeted therapy, immunotherapy, cell therapy, local radiotherapy, and interventional therapy) before surgery. 3. Patients who underwent radical surgery within the first 8 weeks and meet the following criteria: a. Histologically confirmed negative surgical margins (R0) for radical surgery: 1) No residual cancer on gross intraoperative or postoperative imaging; 2) Liver margins\>1cm from tumor boundary, or margins ≤1cm with no tumor cell remnants in resected pathological tissue; b. Imaging examination (enhanced chest CT, abdominal CT or MRI, pelvic CT or MRI) performed ≥4 weeks after surgical resection or ablation to confirm complete radiological response. 4. ECOG score ranges from 0 to 1. 5. Patients meeting any of the following high-risk factors for hepatocellular carcinoma recurrence after radical surgery: 1) Single tumor\>5 cm 2) Concurrent vascular invasion (microvascular invasion or major vessel invasion Vp1-2) 3) Multiple lesions with ≥3 tumors 4) Tumor grade Edmondson III-IV 5) Surgical margin ≤1cm 6. For patients with preoperative AFP elevation, post-radical surgery or ablation, AFP levels must have significantly decreased and show no significant upward trend. 7. Subjects with Hepatitis B or C Virus(HBV or HCV) infection must undergo standardized antiviral therapy prior to enrollment and continue the treatment during the study period. 8. The patient must have adequate organ and bone marrow function, with laboratory test values meeting the following criteria: 1) Complete blood count (CBC): Absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelet count (PLT) ≥80×10⁹/L; hemoglobin (Hb) ≥90 g/L; 2) Liver function: Serum totalbilirubin (TBIL) ≤2×upper limit of normal (ULN), or direct bilirubin ≤ULN for subjects with TBIL\>2×ULN; alanineaminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN; serum albumin ≥28 g/L; 3) Renal function: Serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance (CCr) ≥45 mL/min (Cockcroft-Gault formula) for subjects with Cr\>1.5×ULN; 4) Urinalysis shows urine protein \<2+; For subjects with baseline urinalysis showing proteinuria ≥2+ in routine urine tests, 24-hour urine collection should be performed with 24-hour urine protein quantification \<1g; 5) Coagulation function: International Normalized Ratio (INR) or Activated Partial Thromboplastin Time (APTT) ≤1.5×Upper Limit of Normal (ULN). 9. Life expectancy exceeding 12 months. 10. Not pregnant. Exclusion Criteria: 1. Presence of extrahepatic metastasis, residual lesions, or recurrence on imaging after surgery or ablation. 2. Patients who have undergone adjuvant therapies such as transarterial chemoembolization (TACE) after radical surgery. 3. Child-Pugh classification grade B or C, or a history of hepatic encephalopathy. 4. Presence of clinically significant pericardial effusion; or clinical symptoms requiring drainage of pleural effusion or ascites. 5. History of bleeding events within 6 months prior to enrollment, such as esophageal or gastric variceal bleeding caused by portal hypertension. Subjects with esophageal or gastric varices requiring intervention within 28 days before enrollment. Untreated or inadequately treated esophageal or gastric varices deemed by investigators to pose a high risk of bleeding. 6. The subject is unable to undergo contrast-enhanced liver CT or MRI scans. 7. Patients who do not meet the criteria for radical surgery. 8. Received Chinese herbal medicine or Chinese patent medicine with antitumor indications or immunomodulatory drugs (including systemic use of thymosin, interferon, etc.) within 14 days prior to enrollment. 9. Participation in other drug clinical trials within 4 weeks prior to enrollment. 10. Co-infection with HBV and HCV (defined as HCV infection history with negative HCV RNA, which was considered as non-infection in this study). 11. History of arterial or venous thromboembolic events occurring within 6 months prior to enrollment, including myocardial infarction (MI), unstable angina, cerebrovascular accident or transient ischemic attack (TIA), pulmonary embolism (PE), deep vein thrombosis (DVT), or any other severe thromboembolic event. 12. Patients with cardiopulmonary insufficiency. 13. Severe infection in the active phase or with poor clinical control. A severe infection within 4 weeks prior to the first treatment, including but not limited to hospitalization due to infection, bacteremia, or severe pneumonia complications. 14. Known hypersensitivity to any investigational drug ingredients; or a history of severe allergic reactions to other traditional Chinese patent medicines. 15. Known history of drug abuse, alcoholism, or substance use. 16. Individuals with a history of psychiatric disorders and lacking capacity for conduct or having limited capacity for conduct. 17. Other acute or chronic diseases, mental disorders, or abnormal laboratory test results that may lead to the following outcomes: increased risks for the subject to participate in the study or receive study treatment, interference with the interpretation of study results, or, at the investigator's discretion, that participation in the study is not in the subject's best interest.
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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 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
Locations
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Clinical Medical College of Yangzhou University
RECRUITINGYangzhou, Jiangsu, 225001, China
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