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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Aged between 18 and 75 years.
- 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.
- No prior anticancer therapy for HCC(Excluding patients who have received two or fewerTACE treatments).
- ECOG PS score of 0-1.
- Child-Pugh class A to B.
- 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).
- At least one radiographically measurable lesion according to mRECIST.
- 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.
- Adequate organ function based on laboratory test results.
- 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.
- Patients expected to survive more than 3 months.
- Not planning to become pregnant.
Exclusion
Exclusion Criteria:
- Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed hepatocellularcarcinoma, and fibrolamellar cell carcinoma.
- Extrahepatic metastasis of HCC.
- Diffuse HCC or intrahepatic tumor burden ≥ 50% (including contralateral portal veintumor thrombus, superior mesenteric vein tumor thrombus, and inferior vena cava tumorthrombus).
- Contraindications to TACE or epirubicin.
- Known hypersensitivity to lenvatinib ingredients.
- Known hypersensitivity to the active ingredient or excipients of Camrelizumab.
- Presence of other malignancies.
- Pregnancy, lactation, or unwillingness to use effective contraceptive measures.
- Class II or higher myocardial ischemia or infarction, poorly controlled arrhythmia,cardiac insufficiency class III-IV, or LVEF < 50%.
- Abnormal coagulation function or bleeding tendency.
- History of psychiatric disorders or substance abuse.
- HIV infection.
- Allogeneic organ transplantation or allogeneic hematopoietic stem celltransplantation.
- Active infection.
- Poor compliance such as floating population.
- Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents.
- Active autoimmune disease requiring systemic therapy within 2 years prior to the firstdose.
- Systemic glucocorticoid or immunosuppressive therapy within 7 days prior to the firstdose.
- Clinically uncontrolled pleural/peritoneal effusion.
- Active chronic hepatitis B or C.
- 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
ChinaActive - Recruiting

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