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Compares treatment options for Hepatocellular Carcinoma
Official title Concurrently vs Sequentially Combined HAIC With Targeted and Immunotherapy in Potentially Resectable HCC
ClinicalTrials.gov ID: NCT06041477
What this study is testing
What is Oxaliplatin,calcium folinic acid, levofolinic acid, 5-FU?
Oxaliplatin,calcium folinic acid, levofolinic acid, 5-FU is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatocellular carcinoma.
Also referred to as Hepatic arterial infusion chemotherapy (HAIC).
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
- The goal of this clinical trial is to compare HAIC concurrently with sequentially combined with targeted and immunotherapies in terms of efficacy and safety in patients with potentially resectable intermediate and advanced HCC (CNLC stage IIa\~IIIa). The main questions it aims to answer are: Does a "strong combination" regimen of three simultaneous treatments (HAIC, targeted agents and immunotherapy) definitely result in a higher surgical conversion rate and better survival benefit?
- Phase 3: a large, late-stage study
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 and ≤75 years;
- ECOG PS score of 0\~1;
- Clinical or pathological diagnosis of hepatocellular carcinoma and meeting the stage IIa-IIIa of CNLC staging according to the relevant definitions...
- Not having received previous treatment against hepatocellular carcinoma;
- Those who cannot be surgically resected after discussion by the multidisciplinary team of the participating centers , but have a potential chance of...
You likely can't join if
- Those with severe comorbidity including cardiac, cerebral, pulmonary, renal, and other vital organ function damage, combined with severe infections...
- Those with a history of other malignant tumors;
- Those with a history of related drug allergy;
- Those with known hypersensitivity to any component of the targeted and immunologic drugs to be applied;
- Those with a history of organ transplantation;
- Those who have received previous treatment targeting hepatocellular carcinoma (including interferon);
See the full eligibility criteria
- Age ≥18 and ≤75 years;
- ECOG PS score of 0\~1;
- Clinical or pathological diagnosis of hepatocellular carcinoma and meeting the stage IIa-IIIa of CNLC staging according to the relevant definitions in the 2015 edition of the Guidelines for Standardized Pathological...
- Not having received previous treatment against hepatocellular carcinoma;
- Those who cannot be surgically resected after discussion by the multidisciplinary team of the participating centers , but have a potential chance of resection after conversion therapy, including: multiple tumors located...
- Laboratory tests meet the following conditions, or the following conditions can be achieved with short-term treatment: Neutrophil count ≥2.0×109/L; Hemoglobin ≥ 100 g/L; Platelet count ≥ 75 × 109/L; Plasma albumin level...
- Patients were fully informed about the study and signed an informed consent form.
- Those with severe comorbidity including cardiac, cerebral, pulmonary, renal, and other vital organ function damage, combined with severe infections or other serious concomitant diseases (\> grade 2 CTCAE Version 5.0...
- Those with a history of other malignant tumors;
- Those with a history of related drug allergy;
- Those with known hypersensitivity to any component of the targeted and immunologic drugs to be applied;
- Those with a history of organ transplantation;
- Those who have received previous treatment targeting hepatocellular carcinoma (including interferon);
- Those with co-infection with HIV;
- Those with drugs abuse;
- Those who have had gastrointestinal bleeding or cardiovascular events within the last 30 days;
- Pregnant or breastfeeding women, or women of childbearing age who do not wish to use contraception;
- Persons with concomitant psychiatric disorders that preclude informed consent or affect acceptance of treatment;
- Other factors that may affect patient enrollment and assessment results.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, 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 Guangzhou, Guangdong, 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.