Efficacy and Safety of Lenvatinib as an Adjuvant Therapy for Hepatocellular Carcinoma

• Status: Recruiting
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: All

Summary

Lenvatinib is the standard of care for patients with advanced hepatocellular carcinoma (HCC). The aim of the single-arm, open-label, phase II clinical trial is to evaluate the efficacy and safety of lenvatinib as an adjuvant therapy for patients underwent radical resection of HCC with a high risk of tumor recurrence.

Investigator hypothesize that lenvatinib may be an effective adjuvant treatment for HCC, and 12-month adjuvant treatment with lenvatinib can improve one-year recurrence-free survival rate (RFS) of HCC patients after surgical resection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Zhongshan Hospital
• Collaborators: Anhui Provincial Hospital; Tongji Hospital; West China Hospital
• Treatments: Lenvatinib

Criteria

Inclusion Criteria:

1. Male or female patients aged 18-75;

2. Histological diagnosis of HCC;

3. Tumor stage before surgery: IIb/IIIa stage (>3 tumor nodules, or vascular invasion) HCC according to China Liver Cancer Staging System (or BCLC B/C/PVTT);

4. Underwent R0 resection (microscopic or macroscopic tumor clearance) in four to six weeks before recruitment; no residual tumor before recruitment by imaging study (MRI/CT), nor metastases to other organs;

5. Adequate liver, renal functions;

6. Written informed consent;

7. ECOG 0-1 and Child-Pugh A.

Exclusion Criteria:

1. WBC<4.0*10^9/L, HB<80 g/L, and PLT<75*10^9/L at blood screening;

2. Coagulation function: (prothrombin time) international normalized ratio (INR) >2.3, or extension of prothrombin time>6 seconds;

3. Liver function: serum albumin (ALB)<2.8 g/dl, total bilirubin (TBIL)>51.3μmol/L, alanine aminotransferase and aspartate aminotransferase (ALT and AST)>5 times the upper limit of normal range;

4. Renal function: serum creatinine (Cr)>1.5 times the upper limit of normal range;

5. lymph node metastases;

6. The participant has uncontrolled ascites, hepatic encephalopathy, Gilbert's syndrome, and sclerosing cholangitis, etc.;

7. The participant was included in other clinical trials 30 days before the selection;

8. Other conditions that the investigators considered that not unsuitable for inclusion.