Combining Lenvatinib, TACE, and Camrelizumab for Advanced Liver Cancer Treatment

Lenvatinib Combined With Transcatheter Arterial Chemoembolization and Camrelizumab Versus Lenvatinib Combined With Transcatheter Arterial Chemoembolization in Conversion Resection for Advanced Hepatocellular Carcinoma:A Randomized, Open-label, Parallel-controlled, Phase III Study(LEN-TAC Study)

This study is testing a new combination treatment of lenvatinib, TACE, and camrelizumab to see if it helps people with advanced liver cancer live longer compared to using lenvatinib and TACE alone.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 196 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: West China Hospital (other)
• Drugs / interventions: Camrelizumab, lenvatinib
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT05738616 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of a combination therapy involving lenvatinib, transcatheter arterial chemoembolization (TACE), and camrelizumab for patients with advanced hepatocellular carcinoma (HCC). It aims to determine whether this triple therapy can improve overall survival compared to a dual therapy of lenvatinib and TACE alone. The study will enroll 196 patients with BCLC stage C HCC, who will be rigorously screened to meet specific eligibility criteria. The trial is designed as a randomized, open-label, parallel-controlled study to provide insights into new treatment strategies for advanced HCC.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with advanced hepatocellular carcinoma that meets specific diagnostic criteria and has not received prior anticancer therapy.

Not a fit: Patients with extensive liver disease or those who have received more than two TACE treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could significantly improve survival rates for patients with advanced hepatocellular carcinoma.

How similar studies have performed: While the combination of these therapies is promising, the specific approach of this trial is novel and has not been extensively tested in previous studies.

Eligibility criteria

Inclusion Criteria:

1. Aged between 18 and 75 years.
2. Patients with HCC who strictly meet the criteria outlined in the Guidelines for the Diagnosis and Treatment of Hepatocellular Carcinoma (2022Edition), or those diagnosed by histopathology or cytology.
3. No prior anticancer therapy for HCC(Excluding patients who have received two or fewer TACE treatments).
4. ECOG PS score of 0-1.
5. Child-Pugh class A to B.
6. BCLC stage C Patients: tumor localized in one half of the liver with portal vein tumor thrombus (Vp1-Vp4 patients without contralateral portal vein tumor thrombus).
7. At least one radiographically measurable lesion according to mRECIST.
8. For HBsAg-positive patients, HBV-DNA \< 2000 IU/ml (10\^4 copies/ml) when undergoing PD-1 monoclonal antibody treatment; HCV RNA negative when HCV antibody is positive.
9. Adequate organ function based on laboratory test results.
10. Adequate blood pressure control with up to 3 antihypertensive agents, defined as BP ≤ 150/90 mmHg at screening with no changes in antihypertensive therapy within 1 week prior to Cycle 1/Day 1.
11. Patients expected to survive more than 3 months.
12. Not planning to become pregnant.

Exclusion Criteria:

1. Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed hepatocellular carcinoma, and fibrolamellar cell carcinoma.
2. Extrahepatic metastasis of HCC.
3. Diffuse HCC or intrahepatic tumor burden ≥ 50% (including contralateral portal vein tumor thrombus, superior mesenteric vein tumor thrombus, and inferior vena cava tumor thrombus).
4. Contraindications to TACE or epirubicin.
5. Known hypersensitivity to lenvatinib ingredients.
6. Known hypersensitivity to the active ingredient or excipients of Camrelizumab.
7. Presence of other malignancies.
8. Pregnancy, lactation, or unwillingness to use effective contraceptive measures.
9. Class II or higher myocardial ischemia or infarction, poorly controlled arrhythmia, cardiac insufficiency class III-IV, or LVEF \< 50%.
10. Abnormal coagulation function or bleeding tendency.
11. History of psychiatric disorders or substance abuse.
12. HIV infection.
13. Allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
14. Active infection.
15. Poor compliance such as floating population.
16. Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents.
17. Active autoimmune disease requiring systemic therapy within 2 years prior to the first dose.
18. Systemic glucocorticoid or immunosuppressive therapy within 7 days prior to the first dose.
19. Clinically uncontrolled pleural/peritoneal effusion.
20. Active chronic hepatitis B or C.
21. Vaccination with live vaccines within 30 days prior to the first dose.

Where this trial is running

Chengdu, Sichuan

• HuaXi hospital — Chengdu, Sichuan, China (RECRUITING)

Study contacts

• Study coordinator: Tianfu Wen, Professor

Conditions: Advanced Hepatocellular Carcinoma, Conversion resection, Lenvatinib, Transcatheter arterial chemoembolization, Camrelizumab, Advanced hepatocellular carcinoma