NCT07322848 DEB-TACE vs cTACE in HCC After TIPS
| NCT ID | NCT07322848 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | First Affiliated Hospital, Sun Yat-Sen University |
| Condition | Hepatocellular Carcinoma (HCC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 206 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2029-12-31 |
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.
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 206 participants in total. It began in 2025-12-01 with a primary completion date of 2029-12-31.
⚠ 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 is a Phase 3, open-label, multicenter, randomized controlled clinical trial designed to evaluate the efficacy and safety of Drug-Eluting Bead Transarterial Chemoembolization (DEB-TACE) compared with Conventional Transarterial Chemoembolization (cTACE) in patients with hepatocellular carcinoma (HCC) that is beyond the Milan criteria and who have previously undergone a Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure. The TIPS procedure is commonly performed to manage complications of portal hypertension, such as variceal bleeding or refractory ascites, in patients with cirrhosis. However, after TIPS, treatment options for HCC-particularly in cases exceeding the Milan criteria-remain limited and not well-defined in current guidelines. While TACE is a standard locoregional therapy for intermediate-stage HCC, its application in patients with a prior TIPS is controversial due to altered hepatic hemodynamics, which may increase the risk of liver toxicity and compromise treatment safety and efficacy. Preliminary retrospective data suggest that DEB-TACE, which uses calibrated drug-eluting microspheres, may offer a safer and more effective alternative to cTACE in this specific patient population by providing more controlled drug delivery and potentially reducing systemic and hepatic toxicity. The primary objective of this study is to determine whether DEB-TACE improves Overall Survival (OS) compared to cTACE in patients with beyond-Milan HCC after TIPS. Secondary objectives include comparing the safety profile, Progression-Free Survival (PFS), Objective Response Rate (ORR), Disease Control Rate (DCR), and Quality of Life (QoL) between the two treatment arms. The study aims to enroll 206 participants who will be randomly assigned in a 1:1 ratio to receive either DEB-TACE or cTACE. The trial will include a 24-month recruitment period and a 24-month treatment and follow-up phase, with a total study duration of 48 months. By directly comparing these two TACE approaches in a prospectively defined and randomized setting, this study seeks to provide high-level evidence to guide the optimal locoregional treatment strategy for HCC patients with a history of TIPS placement.
Eligibility Criteria
Inclusion Criteria: 1. histologically or clinically confirmed primary hepatocellular carcinoma, beyond Milan criteria (single lesion \>5 cm OR ≥3 lesions with at least one ≥3 cm). At least one intrahepatic measurable lesion with tumor burden ≤50%, no distant metastasis. No prior antitumor therapy within 12 months before enrollment. 2. underwent TIPS procedure for secondary prevention of variceal bleeding or refractory ascites. Confirmed patent TIPS at 1-month follow-up with portosystemic blood flow visible throughout the shunt and Doppler velocity \> 60 cm/s. 3. child-Pugh class A or B. 4. estimated survival ≥3 months. 5. adequate organ function:Neutrophils ≥1.5 × 10⁹/L; Platelets ≥50 × 10⁹/L; Hemoglobin ≥90 g/L; Serum albumin ≥30 g/L; Bilirubin ≤50 μmol/L; AST/ALT ≤5 × upper limit of normal (ULN), ALP ≤4 × ULN; INR ≤2.3; Creatinine ≤1.5 × ULN. Exclusion Criteria: 1. diffuse hepatic infiltration, unassessable lesions on imaging, or tumor burden \>50%. 2. simultaneous portal vein branch tumor thrombus or main portal vein tumor thrombus. 3. underwent liver transplantation or antitumor therapy after TIPS placement. 4. contraindications to TACE (e.g., portosystemic shunt, hepatofugal blood flow, significant atherosclerosis). 5. presence of brain metastases. 6. Allergy to contrast agents. 7. pregnancy, breastfeeding, or planning pregnancy within 2 years. 8. co-infection with HIV or syphilis. 9. concurrent other malignancy or history of other malignancy within the past 5 years. 10. severe cardiac, renal, or other organ dysfunction. 11. active clinically severe infection \> Grade 2 (per NCI-CTC v5.0). 12. psychiatric/psychological conditions that may impair informed consent. 13. participation in other drug clinical trials within 12 months prior to enrollment.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07322848 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Hepatocellular Carcinoma (HCC). 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 NCT07322848 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 206 participants.
Is NCT07322848 currently recruiting?
Yes, NCT07322848 is actively recruiting participants. Contact the research team at fwzhe@mail.sysu.edu.cn for enrollment information.
Where is the NCT07322848 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07322848 clinical trial?
NCT07322848 is sponsored by First Affiliated Hospital, Sun Yat-Sen University. The trial plans to enroll 206 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.