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Tests treatment safety and results for Hepatocellular Carcinoma (HCC)
Official title Efcacy and Safety of Postoperative Adjuvant Hepatic Arterial Infusion Chemotherapy With mFOLFOX in Hepatocellular Carcinoma With High-risk Recurrence Factors
ClinicalTrials.gov ID: NCT07337421
What this study is testing
What is mFOLFOX ：Oxaliplatin,leucovorin calcium,5-fluorouracil?
mFOLFOX ：Oxaliplatin,leucovorin calcium,5-fluorouracil is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatocellular carcinoma (hcc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-center, single-arm, prospective trial to explore the efficacy and safety of postoperative adjuvant hepatic arterial infusion chemotherapy(HAIC) with mFOLFOX in hepatocellular carcinoma with high-risk recurrence factors.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age ≥18 years and ≤75 years.
- Histologically/cytologically confirmed hepatocellular carcinoma (HCC) (fibrotic HCC and mixed HCC/biliary carcinoma subtypes were excluded from )...
- Patients who underwent radical surgery within the first 8 weeks and meet the following criteria: a. Histologically confirmed negative surgical...
- ECOG score ranges from 0 to 1.
- Patients meeting any of the following high-risk factors for hepatocellular carcinoma recurrence after radical surgery: 1) Single tumor\>5 cm 2)...
You likely can't join if
- Presence of extrahepatic metastasis, residual lesions, or recurrence on imaging after surgery or ablation.
- Patients who have undergone adjuvant therapies such as transarterial chemoembolization (TACE) after radical surgery.
- Child-Pugh classification grade B or C, or a history of hepatic encephalopathy.
- Presence of clinically significant pericardial effusion; or clinical symptoms requiring drainage of pleural effusion or ascites.
- History of bleeding events within 6 months prior to enrollment, such as esophageal or gastric variceal bleeding caused by portal hypertension. people...
- The subject is unable to undergo contrast-enhanced liver CT or MRI scans.
See the full eligibility criteria
- Age ≥18 years and ≤75 years.
- Histologically/cytologically confirmed hepatocellular carcinoma (HCC) (fibrotic HCC and mixed HCC/biliary carcinoma subtypes were excluded from ), with no prior treatment for HCC (including but not limited to...
- 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...
- ECOG score ranges from 0 to 1.
- 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...
- For patients with preoperative AFP elevation, post-radical surgery or ablation, AFP levels must have significantly decreased and show no significant upward trend.
- people 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.
- 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)...
- Life expectancy exceeding 12 months.
- Not pregnant.
- Presence of extrahepatic metastasis, residual lesions, or recurrence on imaging after surgery or ablation.
- Patients who have undergone adjuvant therapies such as transarterial chemoembolization (TACE) after radical surgery.
- Child-Pugh classification grade B or C, or a history of hepatic encephalopathy.
- Presence of clinically significant pericardial effusion; or clinical symptoms requiring drainage of pleural effusion or ascites.
- History of bleeding events within 6 months prior to enrollment, such as esophageal or gastric variceal bleeding caused by portal hypertension. people with esophageal or gastric varices requiring intervention within 28...
- The subject is unable to undergo contrast-enhanced liver CT or MRI scans.
- Patients who do not meet the criteria for radical surgery.
- 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.
- Participation in other drug clinical trials within 4 weeks prior to enrollment.
- Co-infection with HBV and HCV (defined as HCV infection history with negative HCV RNA, which was considered as non-infection in this study).
- 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)...
- Patients with cardiopulmonary insufficiency.
- 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...
- Known hypersensitivity to any investigational drug ingredients; or a history of severe allergic reactions to other traditional Chinese patent medicines.
- Known history of drug abuse, alcoholism, or substance use.
- Individuals with a history of psychiatric disorders and lacking capacity for conduct or having limited capacity for conduct.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Yangzhou, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Yangzhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.