Clinical trial for HCC - Hepatocellular Carcinoma
Official title ICIs and Anti-VEGF Antibody/TKIs With or Without Interventional Therapy for Advanced HCC
ClinicalTrials.gov ID: NCT07157969
What this study is testing
What is Lenvatinib?
Lenvatinib is an investigational medicine, given as an once-daily, being studied as a potential treatment for hcc - hepatocellular carcinoma.
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 trial is designed to explore the efficacy and safety of interventional therapy combined with immune checkpoint inhibitors(ICIs) and anti-vascular endothelial growth factor(VEGF) antibody/tyrosine kinase inhibitors in the treatment of advanced hepatocellular carcinoma. Eligible participants will be divided into two groups based on their treatment plans: one receiving ICIs combined with anti-VEGF drugs, and the other receiving ICIs combined with anti-VEGF drugs alongside interventional therapy, which includes C-TACE, D-TACE, and HAIC.
- 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 and older
You may be able to join if
- people voluntarily participate in the study, provide written informed consent, demonstrate good compliance, and are cooperative with follow-up.
- Age ≥18 years at the time of signing informed consent, regardless of gender.
- Diagnosis of hepatocellular carcinoma confirmed by imaging (according to AASLD criteria), histology, or cytology.
- BCLC Stage B or C.
- At least one measurable lesion per RECIST 1.1.
You likely can't join if
- Patients with hepatocellular carcinoma who are candidates for surgical radical cure, or have undergone radical surgery without evaluable lesions, or...
- Pregnant or breastfeeding women.
- Individuals with known allergy or intolerance to recombinant humanized PD-1/PD-L1 monoclonal antibody preparations.
- Received local-regional therapy within 4 weeks before the first dose of the study drug, including but not limited to surgery, radiotherapy, hepatic...
- History of other malignant tumors within 5 years prior to screening, except for hepatocellular carcinoma.
- Presence of unhealed severe wounds, active ulcers, or untreated fractures.
See the full eligibility criteria
- people voluntarily participate in the study, provide written informed consent, demonstrate good compliance, and are cooperative with follow-up.
- Age ≥18 years at the time of signing informed consent, regardless of gender.
- Diagnosis of hepatocellular carcinoma confirmed by imaging (according to AASLD criteria), histology, or cytology.
- BCLC Stage B or C.
- At least one measurable lesion per RECIST 1.1.
- ECOG score of 0-1.
- Child-Pugh liver function class A or B.
- Life expectancy ≥ 3 months.
- Adequate hematological and organ function.
- Patients with hepatocellular carcinoma who are candidates for surgical radical cure, or have undergone radical surgery without evaluable lesions, or have a history of or are planned for liver transplantation.
- Pregnant or breastfeeding women.
- Individuals with known allergy or intolerance to recombinant humanized PD-1/PD-L1 monoclonal antibody preparations.
- Received local-regional therapy within 4 weeks before the first dose of the study drug, including but not limited to surgery, radiotherapy, hepatic artery embolism, TACE, hepatic artery infusion, radiofrequency...
- History of other malignant tumors within 5 years prior to screening, except for hepatocellular carcinoma.
- Presence of unhealed severe wounds, active ulcers, or untreated fractures.
- Active autoimmune disease or history of autoimmune disorders.
- Significant history of gastrointestinal diseases.
- Significant history of cardiovascular or cerebrovascular diseases.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, 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.