An exploratory study on the efficacy and safety of lenvatinib combined with TACE in neoadjuvant therapy for patients with locally advanced hepatocellular carcinoma

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2000035326

Enrollment

Unknown

Registered

2020-08-08

Start date

2021-01-01

Completion date

Unknown

Last updated

2020-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Interventions

Single arm:Lenvatinib combined with TACE

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Male or female patients 18-75 years old; 2) Histopathological or clinical diagnosis is hepatocellular carcinoma; 3) At least one untreated intrahepatic lesion that can be evaluated by enhanced CT or MRI; 4) CNLC IIa, IIb and IIIa (PVTT grade Vp1-Vp3) patients; 5) Judgment criteria for resectable: According to the preoperative imaging examination, it is expected that the tumor can be resected with R0 and the residual liver volume is sufficient (the residual liver volume of patients without cirrhosis accounts for more than 30% of the standard liver volume; the residual liver volume of patients with liver cirrhosis accounts for The standard liver volume is more than 40%); the cardiopulmonary system examination does not have the contraindications of laparotomy or laparoscopic liver resection considered by the researchers. 6) ECOG score 0-1 points, Child-Pugh grade A; 7) Sign written informed consent.

Exclusion criteria

Exclusion criteria: 1) Hematology examination WBC 1.2; 3) Liver function indicators: serum albumin (ALB) 1.5 times the upper limit of normal (exclude biliary obstruction), serum transaminase (ALT and AST) > 3 times normal The upper limit of the value; renal function indicators: serum creatinine (CR) > 1.5 times the upper limit of normal; uncontrollable hypertension (> 150/90mmHg); 4) Hilar and hilar lymph node metastasis and adhesion of surrounding tissues; 5) Participated in other clinical trials 30 days before screening; 6) Accompanied by ascites, hepatic encephalopathy, Gilbert syndrome, sclerosing cholangitis, etc. 7) Suspected allergy to study drug. 8) Combined with insufficiency of other organs, it is expected that the patient cannot tolerate general anesthesia or hepatectomy. 9) The researcher believes that it is not suitable to participate in the clinical trial.

Design outcomes

Primary

Measure	Time frame
Pathological remission rate;event-free survival;	—

Secondary

Measure	Time frame
Surgical resection rate;OS;ORR;AFP;	—

Countries

China

Contacts

Public ContactZhen-Bin Ding

Zhongshan Hospital Fudan University

ding.zhenbin@zs-hospital.sh.cn+86 13636388572

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026