Lenvatinib Combined With TACE and Camrelizumab in Conversion Resection for Advanced Hepatocellular Carcinoma (LEN-TAC Study)

Last updated: April 19, 2024
Sponsor: Wen Tianfu
Overall Status: Active - Recruiting

Phase

3

Condition

Carcinoma

Treatment

Lenvatinib combined with TACE and Camrelizumab

Clinical Study ID

NCT05738616
HX-IRB-AF-03-V1.0
  • Ages 18-75
  • All Genders

Study 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

Inclusion Criteria:

  1. Aged between 18 and 75 years.
  2. Patients with HCC who strictly meet the criteria outlined in the Guidelines for theDiagnosis and Treatment of Hepatocellular Carcinoma (2022Edition), or those diagnosedby histopathology or cytology.
  3. No prior anticancer therapy for HCC(Excluding patients who have received two or fewerTACE 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 tumorthrombus (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 undergoingPD-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 weekprior to Cycle 1/Day 1.
  11. Patients expected to survive more than 3 months.
  12. Not planning to become pregnant.

Exclusion

Exclusion Criteria:

  1. Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed hepatocellularcarcinoma, and fibrolamellar cell carcinoma.
  2. Extrahepatic metastasis of HCC.
  3. Diffuse HCC or intrahepatic tumor burden ≥ 50% (including contralateral portal veintumor thrombus, superior mesenteric vein tumor thrombus, and inferior vena cava tumorthrombus).
  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 celltransplantation.
  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 firstdose.
  18. Systemic glucocorticoid or immunosuppressive therapy within 7 days prior to the firstdose.
  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.

Study Design

Total Participants: 196
Treatment Group(s): 1
Primary Treatment: Lenvatinib combined with TACE and Camrelizumab
Phase: 3
Study Start date:
May 10, 2024
Estimated Completion Date:
December 01, 2027

Connect with a study center

  • HuaXi hospital

    Chengdu, Sichuan 610000
    China

    Active - Recruiting

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