Combining chemotherapy and immunotherapy for advanced liver cancer after previous treatment failure
Hepatic Arterial Infusion Chemotherapy in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced Hepatocellular Carcinoma After the Failure of Systemic Therapy Recommended by BCLC
This study is testing a new combination of targeted chemotherapy and immunotherapy to see if it can help people with advanced liver cancer who didn't respond to previous treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | First Hospital of China Medical University Academic / other |
| Drugs / interventions | Lenvatinib, chemotherapy |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT06632093 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) combined with PD-1 inhibitors and Lenvatinib in patients with intermediate to advanced hepatocellular carcinoma (HCC) who have not responded to prior systemic therapies. The approach aims to enhance treatment outcomes by utilizing a targeted chemotherapy method alongside immunotherapy. Patients will be monitored for their response to this combination therapy, focusing on measurable intrahepatic lesions and overall health status.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with BCLC stage C hepatocellular carcinoma who have experienced treatment failure with systemic therapies.
Not a fit: Patients with other malignant tumors or those who have not met the specific treatment timelines may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced liver cancer who have exhausted other therapies.
How similar studies have performed: While this approach combines established therapies, the specific combination of HAIC with PD-1 inhibitors and Lenvatinib in this context is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology; 2. Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of portal vein tumor thrombus; 3. Has received previous systemic therapy recommended for HCC by BCLC, and the systemic therapy failed; 4. Both PD-1inhibitors and Lenvatinib patients received only include marketed drugs but are not limited to HCC approval; 5. HAIC was performed after the first PD-1 inhibitor/ Lenvatinib treatment or before treatment; 6. Received at least 2 cycles of HAIC； 7. Has repeated measurable intrahepatic lesions; 8. Child-Pugh class A or B. Exclusion Criteria: 1. The interval between the failure of systemic therapy and the beginning of combination therapy longer than 3 months; 2. With other malignant tumors; 3. Unable to meet criteria of combination timeframe described above.
Where this trial is running
Shenyang, Liaoning
- The first hospital of China medical university — Shenyang, Liaoning, China (Recruiting)
Study contacts
- Study coordinator: Jiaxi Liu
- Email: dmuvictor@163.com
- Phone: +8618940279150
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.