NCT06707233RecruitingPhase 2
Y-90 SIRT for Unresectable HCC Larger Than 7cm
Y-90 Selective Internal Radiation Therapy for Unresectable Hepatocellular Carcinoma Larger Than 7cm: a Prospective, Single Arm Trial
Source: ClinicalTrials.gov · Last updated 28 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a phase II clinical study to evaluate the efficacy and safety of SIRT in patients with HCC greater than 7 cm. After enrollment, patients received yttrium-90 selective internal radiation therapy. The primary endpoint of the study is objective reponse rate (ORR) as assessed by mRECIST. Secondary endpoints were: objective response rate (ORR) as assessed by RECIST 1.1, disease control rate (DCR), progression-free survival (PFS), time to response (TTR), duration of response (DOR), overall survival (OS), and safety (incidence and severity of adverse events).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 33 (estimated)
- First submitted
- 24 Nov 2024
- Start date
- 1 Dec 2024
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06707233
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 33
- From 1 Dec 2024 to the primary completion date, 30 Nov 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.
Other illness
- Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy
- Organ (heart and kidneys) dysfunction
- History of other malignancies
- Uncontrollable infection
- History of organ or cells transplantation
- History of HIV
Other
- Macrovascular invasion or extrahepatic metastasis
- Pregnant or lactating patients
Who the study is looking for
- Pathologically confirmed or clinically diagnosed HCC
- Unresectable HCC as assessed by a team of surgeons
- The largest tumor size \> 7 cm
- Tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment
- At least one measurable intrahepatic target lesion
- Appropriate for SIRT treatment after evaluation (including SPECT/CT evaluation after arterial perfusion with 99Tc-MAA)
- Child-Pugh score ≤ 7
- ECOG PS ≤ 1
- Adequate organ and hematologic function with platelet count ≥75×10\^9/L, leukocyte \>3.0×10\^9/L, Neutrophil count ≥1.5×10\^9/L, haemoglobin ≥85 g/L, ALT and AST≤5×ULN, creatinine≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds
- life expectancy of at least 6 months
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page 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 | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.