Actively Recruiting
Lenvatinib Combined With TACE and Camrelizumab in Conversion Resection for Advanced Hepatocellular Carcinoma (LEN-TAC Study)
Led by Wen Tianfu · Updated on 2024-04-24
196
Participants Needed
1
Research Sites
185 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Compared to systemic therapy alone, conversion therapy is promising to improve the prognosis of patients with advanced hepatocellular carcinoma (HCC). Triple therapy (lenvatinib combined with transcatheter arterial chemoembolization and camrelizumab) may have significant efficacy in conversion therapy for patients with advanced HCC, but its safety and efficacy remain unknown. To address this, we have designed a randomized, open-label, parallel-controlled trial to evaluate the safety and efficacy of lenvatinib combined with transcatheter arterial chemoembolization and camrelizumab versus lenvatinib combined with transcatheter arterial chemoembolization in conversion resection for advanced HCC. Totally 196 patients with BCLC C stage HCC will be rigorously screened and included, and the primary endpoints of the study are overall survival. This study aims to provide valuable insights into new treatment strategies for advanced HCC.
CONDITIONS
Official Title
Lenvatinib Combined With TACE and Camrelizumab in Conversion Resection for Advanced Hepatocellular Carcinoma (LEN-TAC Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 75 years.
- Diagnosis of hepatocellular carcinoma (HCC) based on 2022 Guidelines or confirmed by pathology.
- No prior anticancer therapy for HCC, except up to two TACE treatments.
- ECOG performance status score of 0 or 1.
- Child-Pugh liver function class A or B.
- BCLC stage C with tumor in one half of liver and portal vein tumor thrombus (Vp1-Vp4) without contralateral thrombus.
- At least one measurable tumor lesion on imaging according to mRECIST.
- For hepatitis B patients, HBV-DNA less than 2000 IU/ml during PD-1 treatment; hepatitis C patients must be HCV RNA negative.
- Adequate organ function shown by lab tests.
- Blood pressure controlled at or below 150/90 mmHg using up to three antihypertensive drugs with no recent changes.
- Expected survival longer than 3 months.
- Not planning pregnancy.
You will not qualify if you...
- Diagnosis of intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed HCC, or fibrolamellar carcinoma.
- Presence of cancer spread outside the liver.
- Diffuse HCC or tumor covering 50% or more of liver including certain vein tumor thrombi.
- Contraindications to TACE or epirubicin chemotherapy.
- Allergic reactions to lenvatinib or camrelizumab.
- Other active cancers besides HCC.
- Pregnant, breastfeeding, or unwilling to use contraception.
- Serious heart conditions including ischemia, arrhythmia, heart failure, or low heart function.
- Blood clotting problems or bleeding issues.
- History of psychiatric illness or substance abuse.
- HIV infection.
- Previous organ or stem cell transplantation.
- Active infections.
- Poor treatment compliance or unstable living situation.
- Prior treatment with PD-1/PD-L1/PD-L2 inhibitors.
- Active autoimmune diseases needing treatment in past 2 years.
- Use of systemic steroids or immunosuppressive drugs within 7 days before treatment.
- Uncontrolled fluid buildup in chest or abdomen.
- Active chronic hepatitis B or C infection.
- Recent live vaccine within 30 days before treatment.
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Trial Site Locations
Total: 1 location
1
HuaXi hospital
Chengdu, Sichuan, China, 610000
Actively Recruiting
Research Team
T
Tianfu Wen, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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