NCT06397222 Sintilimab Plus Bevacizumab and SIRT for Intermediate-advanced HCC
| NCT ID | NCT06397222 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University |
| Condition | Hepatocellular Carcinoma Non-resectable |
| Study Type | INTERVENTIONAL |
| Enrollment | 23 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2027-04-30 |
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 23 participants in total. It began in 2024-05-01 with a primary completion date of 2027-04-30.
⚠ 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 study is conducted to evaluate the efficacy and safety of sintilimab, bevacizumab plus Y-90 selective internal radiation therapy (SIRT) for patients with unresectable intermediate-advanced hepatocellular carcinoma (HCC).
Eligibility Criteria
Inclusion Criteria: * Unresectable HCC (BCLC stage B/C or CNLC II/III) with diagnosis confirmed by histology/cytology or clinically * At least one measurable untreated lesion * Intrahepatic tumors can be treated with 1-2 sessions of SIRT * Child-Pugh score 5-7 * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 * Life expectancy of at least 3 months * Patients with active hepatitis B are allowed, but they need to receive antiviral treatment to achieve a HBV DNA\<10\^3 IU/mL * Patients with hepatitis C need to finish the anti-HCV treatment Exclusion Criteria: * tumor extent ≥70% liver occupation * Tumor thrombus involving main portal vein or both the first left and right branches of portal vein * Vena cava invasion * Central nervous system metastasis * Metastatic disease that involves major airways or blood vessels * Patients who previously received hepatic arterial infusion chemotherapy (HAIC), transarterial chemoembolization (TACE), transarterial embolization (TAE), radiotherapy, systemic therapy for HCC * History of organ and cell transplantation * Prior esophageal and/or gastric varices bleeding * Hepatic dysfunction, such as ascites, esophagogastric varices, hepatic encephalopathy * Evidence of portal hypertension with high risk of bleeding * Use of immunosuppressive medications within 4 weeks prior to the first dose of study treatment * Major surgical procedure or unhealed wound, ulcer, or fracture within 4 weeks prior to the first dose of study treatment * Any life-threatening bleeding event within the previous 3 months, including the need for blood transfusion, surgical or localized treatment, or ongoing drug therapy * Peripheral blood white blood cell count \<3×10\^9/L and platelet count \<50×10\^9/L * Prolonged prothrombin time \>4 seconds * Severe organ (heart, lung, kidney) dysfunction * History of other malignancies * Co-infection with hepatitis B and C viruses * Human immunodeficiency virus infection * Pregnant or lactating patients
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06397222 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 NCT06397222 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 NCT06397222 currently recruiting?
Yes, NCT06397222 is actively recruiting participants. Contact the research team at cai020@yeah.net for enrollment information.
Where is the NCT06397222 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06397222 clinical trial?
NCT06397222 is sponsored by Second Affiliated Hospital of Guangzhou Medical University. The trial plans to enroll 23 participants.
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