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New treatment option for Hepatocellular Carcinoma (HCC)
Official title Hepatic Arterial Infusion Chemotherapy and Immunotherapy for Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT06741020
What this study is testing
What is Adebrelimab, Oxaliplatin, Fluorouracil,Leucovorin?
Adebrelimab, Oxaliplatin, Fluorouracil,Leucovorin 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
- Dear Sir/Madam, We would like to invite you to participate in this clinical research, which has been approved by the Medical Ethics Committee of Zhejiang Cancer Hospital. This informed consent form provides you with detailed information to help you decide whether or not to participate in this study.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Aged between 18 and 75 years;
- Preoperative pathological diagnosis or clinically diagnosed liver cancer meeting EASL/AASLD diagnostic criteria. No prior systemic chemotherapy...
- Staging in BCLC Stage A or B, and beyond the Up-to-Seven criteria but deemed resectable (negative margins and remaining liver volume sufficient to...
- ECOG performance status score of 0 before the first medication in the study;
- Liver function classified as Child-Pugh Class A and ICG retention rate at 15 minutes ≤ 10%;
You likely can't join if
- Pathological diagnosis of non-hepatocellular carcinoma;
- Previous treatment for liver cancer-related chemotherapy, radiotherapy, radiofrequency ablation, treatment therapies and targeted therapy...
- Preoperative assessment indicates the tumor is unresectable;
- Viral load limitations: hepatitis B virus (HBV) DNA \> 2000 copies/ml, hepatitis C virus (HCV) RNA \> 1000;
- Long-term hormone users require ongoing systemic hormone treatment (equivalent to \> 10 mg prednisone/day) or any other form of immunosuppressive...
- Clinical significant bleeding events or bleeding tendencies within 3 months prior to enrollment or currently receiving thrombolytic or anticoagulant...
See the full eligibility criteria
- Aged between 18 and 75 years;
- Preoperative pathological diagnosis or clinically diagnosed liver cancer meeting EASL/AASLD diagnostic criteria. No prior systemic chemotherapy, immunotherapy, targeted therapy, or other anti-tumor treatments for HCC;
- Staging in BCLC Stage A or B, and beyond the Up-to-Seven criteria but deemed resectable (negative margins and remaining liver volume sufficient to meet body needs);
- ECOG performance status score of 0 before the first medication in the study;
- Liver function classified as Child-Pugh Class A and ICG retention rate at 15 minutes ≤ 10%;
- Estimated survival time of at least 6 months;
- Organ function levels meet the requirements and are capable of tolerating surgery before the first medication in the study; Key organ function indicators must meet the following criteria: Hemoglobin ≥ 90 g/L, Neutrophil...
- Male and female participants with reproductive potential must agree to use effective contraception throughout the study period;
- Sign a consent form agreeing to provide previously stored blood samples, tumor tissue specimens, or fresh biopsy tumor lesions.
- Pathological diagnosis of non-hepatocellular carcinoma;
- Previous treatment for liver cancer-related chemotherapy, radiotherapy, radiofrequency ablation, treatment therapies and targeted therapy, immunotherapy, or surgical procedures (excluding prior non-tumor-related...
- Preoperative assessment indicates the tumor is unresectable;
- Viral load limitations: hepatitis B virus (HBV) DNA \> 2000 copies/ml, hepatitis C virus (HCV) RNA \> 1000;
- Long-term hormone users require ongoing systemic hormone treatment (equivalent to \> 10 mg prednisone/day) or any other form of immunosuppressive therapy;
- Clinical significant bleeding events or bleeding tendencies within 3 months prior to enrollment or currently receiving thrombolytic or anticoagulant treatment;
- History of autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, etc.;
- Active severe clinical infection (\> Grade 2, NCI-CTCAE Version 5.0), including active tuberculosis; history of active tuberculosis infection within the past year without receiving formal anti-tuberculosis treatment or...
- Uncontrolled diabetes (fasting blood glucose ≥ 10 mmol/L), severe lung disease (such as acute lung disease, pulmonary fibrosis affecting lung function, interstitial lung disease. However, resolved radiation pneumonitis...
- Clinically significant cardiovascular disease; hypertension that is poorly controlled by antihypertensive medications (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg);
- Recipients of renal replacement therapy;
- History of other malignancies within the last 5 years. However, cured skin basal cell carcinoma or cervical carcinoma in situ is excluded;
- Other conditions that are expected to render the participant unable to tolerate surgical treatment;
- Allergic reactions to any components of the study drug;
- Presence of alcohol dependence, mental illnesses, pregnancy (or breastfeeding), or other conditions that make participation in clinical trials inappropriate.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, 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 Hangzhou, Zhejiang, 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.