NCT05608200 Lenvatinib+Sintilimab+TACE vs. Lenvatinib+TACE for Advanced HCC
| NCT ID | NCT05608200 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University |
| Condition | Hepatocellular Carcinoma Non-resectable |
| Study Type | INTERVENTIONAL |
| Enrollment | 427 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 427 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, sintilimab plus TACE (Len-Sin-TACE) compared with lenvatinib plus TACE (Len-TACE) for patients with advanced hepatocellular carcinoma (HCC).
Eligibility Criteria
Inclusion Criteria: * Advanced HCC (BCLC stage C, or CNLC IIIa and IIIb ) with diagnosis confirmed by histology/cytology or clinically * 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: * Obstructive portal vein tumor thrombus involving both the left and right portal vein or main portal vein without collateral vessels * Vascular invasion involving inferior vena cava * Central nervous system metastasis * Patients who received prior systemic therapy, immunotherapy, TACE, transcatheter arterial radioembolization (TARE), transcatheter arterial embolization (TAE), hepatic arterial infusion chemotherapy (HAIC) or radiation therapy for HCC * History of organ and cell transplantation * History of bleeding from esophageal and gastric varices * History of hepatic encephalopathy * hematologic examination: white blood cell count \<3.0×10\^9/L, platelets \<50×10\^9/L * Prothrombin time prolongation ≥ 4s * Severe organ (heart, lung, kidney) dysfunction * History of malignancy other than HCC * Active hepatitis B or C infection; hepatitis B virus (HBV) DNA \> 1000 copies/ml; hepatitis C virus (HCV) RNA \> 1000 copies/ml. Those who possess the indicators lower than the above criteria after nucleotide antiviral treatment can be enrolled
Contact & Investigator
Kangshun Zhu, MD
PRINCIPAL INVESTIGATOR
Second Affiliated Hospital of Guangzhou Medical University
Frequently Asked Questions
Who can join the NCT05608200 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 NCT05608200 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 427 participants.
Is NCT05608200 currently recruiting?
Yes, NCT05608200 is actively recruiting participants. Contact the research team at cai020@yeah.net for enrollment information.
Where is the NCT05608200 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT05608200 clinical trial?
NCT05608200 is sponsored by Second Affiliated Hospital of Guangzhou Medical University. The principal investigator is Kangshun Zhu, MD at Second Affiliated Hospital of Guangzhou Medical University. The trial plans to enroll 427 participants.
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