Combining lenvatinib with VIC-1911 for liver cancer that doesn't respond to lenvatinib
Safety and Efficacy of Lenvatinib Combined With VIC-1911 in the Treatment of Lenvatinib-unresponsive or Lenvatinib-resistant Hepatocellular Carcinoma
This study is testing if combining lenvatinib with a new drug called VIC-1911 can help people with liver cancer who haven't responded to lenvatinib alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Drugs / interventions | Lenvatinib, chemotherapy |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05718882 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to evaluate the safety and effectiveness of lenvatinib in combination with the Aurora kinase A inhibitor VIC-1911 in patients with hepatocellular carcinoma (HCC) who have not responded to or are resistant to lenvatinib treatment. Participants must meet specific criteria, including having measurable tumors and a certain performance status. The study will assess how well this combination therapy works in overcoming resistance to lenvatinib. The goal is to provide a new treatment option for patients with advanced liver cancer.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with advanced hepatocellular carcinoma that has not responded to lenvatinib.
Not a fit: Patients with uncorrectable coagulopathy, active gastrointestinal bleeding, or significant heart disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this combination therapy could offer a new treatment avenue for patients with lenvatinib-resistant liver cancer.
How similar studies have performed: While this approach is novel in the context of lenvatinib resistance, similar studies targeting resistant cancers have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
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 C, and there is at least one measurable tumor in the liver (long diameter ≥ 1cm);(4) Lenvatinib unresponsive or lenvatinib resistant after standard treatment; (5) Child-Pugh A or scored 7 B; (6) Eastern Cooperative Oncology Group performance status score \<= 1; (7) 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) Hepatic encephalopathy or refractory ascites requiring treatment; (6) There is a clear active infection; (7) Receiving radiotherapy/chemotherapy/interventional therapy for tumor within 4 weeks before the start of the study; (8) Severe insufficiency of important organs, such as severe cardiopulmonary insufficiency; (9) Other accompanying anti-tumor treatments; (10) The investigator assessed that the patient was unable or unwilling to comply with the protocol.
Where this trial is running
Shanghai
- Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Lei Xia
- Email: 15003@renji.com
- Phone: 008615800622858
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.