NCT06632093 HAIC in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced HCC After the Failure of Systemic Therapy Recommended by BCLC
| NCT ID | NCT06632093 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Hospital of China Medical University |
| Condition | BCLC Stage B Hepatocellular Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 84 participants |
| Start Date | 2024-09-16 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 84 participants in total. It began in 2024-09-16 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) in combination with PD-1 inhibitors and Lenvatinib in patients with intermediate or advanced-stage hepatocellular carcinoma (HCC) after failure of systemic therapy recommended by BCLC.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06632093 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying BCLC Stage B Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06632093 currently recruiting?
Yes, NCT06632093 is actively recruiting participants. Contact the research team at dmuvictor@163.com for enrollment information.
Where is the NCT06632093 trial being conducted?
This trial is being conducted at Shenyang, China.
Who is sponsoring the NCT06632093 clinical trial?
NCT06632093 is sponsored by First Hospital of China Medical University. The trial plans to enroll 84 participants.
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