Clinical trial · Interventional
Efficacy and Safety of Lenvatinib as a Conversion Therapy for HCC
Efficacy and Safety of Lenvatinib as a Conversion Therapy in Patients With Potentially Resectable Hepatocellular Carcinoma: A Single-Arm and Open-Label Prospective Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 assess efficacy and safety of lenvatinib as a preoperative conversion therapy in patients with potentially resectable HCC. Investigator hypothesized that lenvatinib may be an effective conversion treatment for HCC, and preoperative treatment with lenvatinib can improve resectability in patients with potential resectable HCC and improve the long term survival.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenvatinib 4 mg Oral | Drug | Lenvatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- The patients will receive lenvatinib treatment and will be evaluated for the feasibility of liver resection every 8 weeks. For those who underwent liver resection, they will receive lenvatinib treatment for another 48 weeks. In case of tumor recurrence, intolerance, death, or need for other antitumor treatment, the treatment shall be stopped.
- interventionNames
- Drug: Lenvatinib 4 mg Oral
Primary outcomes (1)
- measure
- Resection rate
- timeFrame
- 1 year after LPI
- description
- The percentage of patients who receive curative liver resection for HCC. The criteria for curative resection: (1) no active tumor thrombosis is observed in hepatic veins, portal veins, bile ducts or inferior vena cava; or the type of portal vein invasion was converted from Vp3/Vp4 to Vp1/Vp2; (2) no active metastasis to adjacent organs or distant organs, or to lymph nodes; (3) the surgical margin ≥ 0.5 cm; (4) the number of active tumor nodules decreases from ≥4 to \<4; (5) the ratio of future liver volume to standard liver volume increases from \<40% to ≥40% (for those with liver cirrhosis) or from \<30% to ≥30% (for those without liver cirrhosis).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female aged 18-75; 2. The participant must have confirmed diagnosis of HCC histologically or clinically; 3. The participant must have at least one untreated intrahepatic lesion that can be evaluated by contrast-enhanced CT or MRI; 4. The BCLC stage B/C patients, more than 3 tumor nodes or have portal vein tumor thrombus (Vp3-Vp4 according to LCSGJ PVTT classification) or extrahepatic metastases limited to one organ and the number of metastases nodules is no more than 3; 5. ECOG PS 0-1 and Child-Pugh A; 6. Surgical resection is not the first choice according to MDT evaluation; 7. Written informed consent; Exclusion Criteria: 1. WBC\<4.0\*10\^9/L, HB\<80 g/L, PLT\<75\*10\^9/L and NEUT\<1.5×10\^9/L; 2. Coagulation function: (prothrombin time) international normalized ratio (INR) \>1.2; 3. Liver function: serum albumin (ALB)\<3.5 g/dl, total bilirubin (TBIL)\>1.5 times the upper limit of normal range, alanine aminotransferase and aspartate aminotransferase (ALT and AST)\>3 times the upper limit of normal range; renal function index: serum creatinine (CRE)\>1.5 times the upper limit of normal range; uncontrolled hypertension (\>150/90mm Hg); 4. Lymph node metastasis to hilar of lung or liver, or peripheral tissue adhesion; 5. Participated in other clinical trials 30 days before enrollment; 6. With ascites, hepatic encephalopathy, Gilbert syndrome, sclerosing cholangitis; 7. Suspected allergy to study drug; 8. With other organ dysfunction, it is not expected to be tolerated general anesthesia or hepatectomy; 9. Other conditions that the investigators considered not unsuitable for inclusion.
References
Publications (0)
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