NCT06707233 Y-90 SIRT for Unresectable HCC Larger Than 7cm
| NCT ID | NCT06707233 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University |
| Condition | Hepatocellular Carcinoma Non-Resectable |
| Study Type | INTERVENTIONAL |
| Enrollment | 33 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2026-11-30 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 33 participants in total. It began in 2024-12-01 with a primary completion date of 2026-11-30.
⚠ 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
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).
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Macrovascular invasion or extrahepatic metastasis * 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 * Pregnant or lactating patients
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06707233 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 NCT06707233 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06707233 currently recruiting?
Yes, NCT06707233 is actively recruiting participants. Contact the research team at cai020@yeah.net for enrollment information.
Where is the NCT06707233 trial being conducted?
This trial is being conducted at Guangzhou, China, Guangzhou, China.
Who is sponsoring the NCT06707233 clinical trial?
NCT06707233 is sponsored by Second Affiliated Hospital of Guangzhou Medical University. The trial plans to enroll 33 participants.
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