NCT05608213 Lenvatinib Plus I-125 Seed Brachytherapy vs. Lenvatinib for TACE-refractory HCC
| NCT ID | NCT05608213 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University |
| Condition | Hepatocellular Carcinoma Non-resectable |
| Study Type | INTERVENTIONAL |
| Enrollment | 187 participants |
| Start Date | 2022-11-02 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 187 participants in total. It began in 2022-11-02 with a primary completion date of 2026-10-31.
⚠ 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
This study is conducted to evaluate the efficacy and safety of lenvatinib plus iodine-125 seed brachytherapy (Len-I) compared with lenvatinib (Len) alone for patients with hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization (TACE).
Eligibility Criteria
Inclusion Criteria: * HCC confirmed by histopathology and/or cytology, or diagnosed clinically * Diagnosis of HCC with TACE refractoriness according to the criteria proposed by Japan Society of Hepatology (2021) * Patients who have Tumor recurrence after surgical resection or ablation are allowed to be included * At least one measurable intrahepatic target lesion * Child-Pugh class A/B * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy of at least 3 months Exclusion Criteria: * Extrahepatic metastasis * Tumor thrombus involving main portal vein or both the first left and right branch of portal vein * Vena cava invasion * Patients who received prior systemic therapy, immunotherapy, hepatic arterial infusion chemotherapy (HAIC) or radiotherapy for HCC * History of organ and cell transplantation * History of bleeding from esophagogastric varices * History of hepatic encephalopathy * Hematologic examination: platelets \<50×10\^9/L * Prothrombin time prolongation ≥ 4s * Severe organ (heart, lung, kidney) dysfunction * History of malignancy other than HCC
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05608213 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Hepatocellular Carcinoma Non-resectable. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05608213 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 187 participants.
Is NCT05608213 currently recruiting?
Yes, NCT05608213 is actively recruiting participants. Contact the research team at cai020@yeah.net for enrollment information.
Where is the NCT05608213 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT05608213 clinical trial?
NCT05608213 is sponsored by Second Affiliated Hospital of Guangzhou Medical University. The trial plans to enroll 187 participants.
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