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Trial Title:
Lenvatinib Combined With TACE and Camrelizumab in Conversion Resection for Advanced Hepatocellular Carcinoma (LEN-TAC Study)
NCT ID:
NCT05738616
Condition:
Advanced Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Lenvatinib
Conditions: Keywords:
Conversion resection
Lenvatinib
Transcatheter arterial chemoembolization
Camrelizumab
Advanced hepatocellular carcinoma
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
Lenvatinib combined with TACE and Camrelizumab
Description:
Once subjects have signed the informed consent and passed screening, they will be
randomized in a 1:1 ratio to either the experimental arm (lenvatinib combined with TACE
and camrelizumab) or the control arm (lenvatinib combined with TACE).
Arm group label:
lenvatinib combined with TACE
Arm group label:
lenvatinib combined with TACE and camrelizumab
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
HuaXi hospital
Address:
City:
Chengdu
Zip:
610000
Country:
China
Status:
Recruiting
Contact:
Last name:
Tianfu Wen, Professor
Phone:
86-18980601471
Email:
wentianfu@scu.edu.cn
Start date:
May 10, 2024
Completion date:
December 1, 2027
Lead sponsor:
Agency:
Wen Tianfu
Agency class:
Other
Source:
West China Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05738616
