NCT06397235 DEB-TACE+RALOX-HAIC vs DEB-TACE for Large HCC
| NCT ID | NCT06397235 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University |
| Condition | Hepatocellular Carcinoma Non-resectable |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 130 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 transarterial chemoembolization with drug-eluting beads (DEB-TACE) combined with hepatic artery infusion chemotherapy (HAIC) with oxaliplatin and raltitrexed (RALOX-HAIC) versus DEB-TACE alone for unresectable large hepatocellular carcinoma (HCC).
Eligibility Criteria
Inclusion Criteria: * HCC confirmed by histology/cytology or diagnosed clinically. * At least one measurable intrahepatic target lesion. * The largest tumor size \> 7 cm. * Tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment. * Child-Pugh score 5-7. * ECOG performance status ≤ 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, ASL and AST≤5×ULN, creatinine clearance≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds. Exclusion Criteria: * Macrovascular invasion or extrahepatic metastasis. * Diffuse HCC. * Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy. * Previous palliative treatments, including TACE, transcatheter arterial embolization, HAIC, radiation therapy, systemic therapy. * Organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment. * History of other malignancies. * Uncontrollable infection. * History of HIV. * Gastrointestinal bleeding within 30 days, or other bleeding\> CTCAE grade 3. * History of organ or cells transplantation. * Pregnant or lactating patients.
Frequently Asked Questions
Who can join the NCT06397235 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 NCT06397235 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 NCT06397235 currently recruiting?
Yes, NCT06397235 is actively recruiting participants. Visit ClinicalTrials.gov or contact Second Affiliated Hospital of Guangzhou Medical University to inquire about joining.
Where is the NCT06397235 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06397235 clinical trial?
NCT06397235 is sponsored by Second Affiliated Hospital of Guangzhou Medical University. The trial plans to enroll 130 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.