Lenvatinib Combined With Gefitinib in the Treatment of Lenvatinib-resistant Hepatocellular Carcinoma

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma; Molecular Targeted Therapy
• Interventions: Drug: Lenvatinib and Gefitinib

• Registration Number: NCT04642547
• Lead Sponsor: RenJi Hospital

Brief Summary

This is a prospective clinical study aiming to tests the safety and efficacy of lenvatinib in combination with gefitinib in people with lenvatinib resistant hepatocellular carcinoma. This study will help find out if lenvatinib and gefitinib is a safe and useful combination for treating patients with lenvatinib resistant hepatocellular carcinoma.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-18
• Study First Submitted QC: 2020-11-18
• Study First Posted: 2020-11-24
• Study Start: 2020-12-02
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-27
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

(1) Unlimited gender, aged 18-75 years; (2) Meets American Association for the Study of Liver Diseases (AASLD) or European Association for the Study of the Liver (EASL) clinical diagnostic criteria of hepatocellular carcinoma; (3) Barcelona Clinic Liver Cancer (BCLC) Stage B or C, and there is at least one measurable tumor in the liver (long diameter ≥ 1cm);(4) progressing after standard treatment; (5) Unresponsive or resistant to Lenvatinib; (6) Child-Pugh A or scored 7 B; (7) Eastern Cooperative Oncology Group performance status score <= 1; (8) Platelet count >= 60x10^9/L, Prothrombin time prolonged <= 6 seconds.

Exclusion Criteria

(1) Uncorrectable coagulopathy with obvious bleeding tendency; (2) Patients need long-term anticoagulant or anti platelet therapy and cannot stop the drugs; (3) Patients with unstable or active ulcer or gastrointestinal bleeding; (4) Heart disease requiring treatment or not well controlled high blood pressure; (5) Patients with interstitial pneumonia; (6) Hepatic encephalopathy or refractory ascites requiring treatment; (7) There is a clear active infection; (8) Receiving radiotherapy/chemotherapy/interventional therapy for tumor within 4 weeks before the start of the study; (9) Severe insufficiency of important organs, such as severe cardiopulmonary insufficiency; (10) Other accompanying anti-tumor treatments; (11) The investigator assessed that the patient was unable or unwilling to comply with the protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Combination therapy with Lenvatinib and Gefitinib	Lenvatinib and Gefitinib	First week: Gefitinib 125mg/day, Lenvatinib 8mg/day if body weight ≤ 60Kg and 12mg/day if body weight \> 60Kg. If the patient is well tolerated, the dose of Gefitinib will be adjusted to 250 mg/day after one week, and the dose of Lenvatinib will remain the same (8mg/day for weight ≤ 60Kg and 12mg/day for weight \> 60Kg). Route of administration: Oral.

Primary Outcome Measures

Name	Time	Method
Progression free survival	6 months after the last subject is enrolled	The estimation of time from start of combination therapy to progression of disease

Secondary Outcome Measures

Name	Time	Method
Overall survival	6 months after the last subject is enrolled	The time between initial combination therapy and the patient's death of any cause or most recent follow-up.
Safety endpoint	6 months after the last subject is enrolled	Statistically describe the proportion of adverse events after treatment for each patient

Trial Locations

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University; 🇨🇳 Shanghai, Shanghai, China