Clinical trial NCT05738616: Lenvatinib Combined With TACE and Camrelizumab in Conversion Resection for Advanced Hepatocellular Carcinoma (LEN-TAC Study)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Advanced Hepatocellular Carcinoma
Keywords: Conversion resection
Lenvatinib
Transcatheter arterial chemoembolization
Camrelizumab
Advanced hepatocellular carcinoma
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Overall survival
timeFrame: 3-year
Secondary outcomes:
measure: Adverse events
timeFrame: 2 years
measure: Objective response rate
timeFrame: 2 years
measure: Disease control rate
timeFrame: 2 years
measure: Event-free survival
timeFrame: 2 years
measure: Overall survival at 2 years
timeFrame: 2 years
measure: Conversional resection rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Chengdu
country: China
facility: HuaXi hospital
state: Sichuan
Study officials:
References: