NCT06397235RecruitingPhase 2
DEB-TACE+RALOX-HAIC vs DEB-TACE for Large HCC
DEB-TACE in Combination With or Without RALOX-based HAIC for Unresectable Large Hepatocellular Carcinoma: A Randomized, Controlled Trial
Source: ClinicalTrials.gov · Last updated 20 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 29 Apr 2024
- Start date
- 1 May 2024
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06397235
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 130
- From 1 May 2024 to the primary completion date, 30 Apr 2027
- 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.
Prior treatment
- Previous palliative treatments, including TACE, transcatheter arterial embolization, HAIC, radiation therapy, systemic therapy.
Other illness
- Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy.
- 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.
Other
- Macrovascular invasion or extrahepatic metastasis.
- Diffuse HCC.
- Pregnant or lactating patients.
Who the study is looking for
- 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.
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 | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.