Clinical trial · Interventional
Lenvatinib Combined With Gefitinib in the Treatment of Lenvatinib-resistant Hepatocellular Carcinoma
A Prospective Clinical Study of Lenvatinib Combined With Gefitinib in the Treatment of Lenvatinib-resistant Hepatocellular Carcinoma
NCT04642547CI-TRIAL-00068420completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
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.
Conditions
Conditions (2)
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 | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Molecular Targeted Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenvatinib and Gefitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combination therapy with Lenvatinib and Gefitinib
- description
- 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.
- interventionNames
- Drug: Lenvatinib and Gefitinib
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- 6 months after the last subject is enrolled
- description
- The estimation of time from start of combination therapy to progression of disease
Secondary outcomes (2)
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDShi Y, Cui D, Xia L, Shi D, Jin G, Wang S, Lin Y, Tang X, Chi J, Wang T, Li M, Lv Z, Zheng J, Jia Q, Yang W, Sun Z, Yang F, Feng H, Yuan S, Zhou W, Qin W, Bernards R, Jin H, Zhai B. Efficacy and safety of lenvatinib plus gefitinib in lenvatinib-resistant hepatocellular carcinomas: a prospective, single-arm exploratory trial. Signal Transduct Target Ther. 2024 Dec 9;9(1):359. doi: 10.1038/s41392-024-02085-8. PMID 39653700
- DERIVEDJin H, Shi Y, Lv Y, Yuan S, Ramirez CFA, Lieftink C, Wang L, Wang S, Wang C, Dias MH, Jochems F, Yang Y, Bosma A, Hijmans EM, de Groot MHP, Vegna S, Cui D, Zhou Y, Ling J, Wang H, Guo Y, Zheng X, Isima N, Wu H, Sun C, Beijersbergen RL, Akkari L, Zhou W, Zhai B, Qin W, Bernards R. EGFR activation limits the response of liver cancer to lenvatinib. Nature. 2021 Jul;595(7869):730-734. doi: 10.1038/s41586-021-03741-7. Epub 2021 Jul 21. PMID 34290403