NCT05608213RecruitingPhase 3
Lenvatinib Plus I-125 Seed Brachytherapy vs. Lenvatinib for TACE-refractory HCC
Lenvatinib Plus Iodine-125 Seed Brachytherapy Compared With Lenvatinib Alone for TACE-refractory Hepatocellular Carcinoma: a Single Center, Prospective, Randomized Control Trail
Source: ClinicalTrials.gov · Last updated 8 Nov 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 187 (estimated)
- First submitted
- 2 Nov 2022
- Start date
- 2 Nov 2022
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT05608213
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 187
- From 2 Nov 2022 to the primary completion date, 31 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who received prior systemic therapy, immunotherapy, hepatic arterial infusion chemotherapy (HAIC) or radiotherapy for HCC
Other illness
- History of organ and cell transplantation
- History of bleeding from esophagogastric varices
- History of hepatic encephalopathy
- Severe organ (heart, lung, kidney) dysfunction
- History of malignancy other than HCC
Lab values
- Hematologic examination: platelets \<50×10\^9/L
Other
- Extrahepatic metastasis
- Tumor thrombus involving main portal vein or both the first left and right branch of portal vein
- Vena cava invasion
- Prothrombin time prolongation ≥ 4s
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The second Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.