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A Prospective Randomized Controlled Trial of Preoperative Transarterial Chemoembolization for Resectable Large Hepatocellular Carcinoma

A prospective randomized controlled trial comparing survival outcome between patients with resectable large hepatocellular carcinoma (HCC) underwent preoperative transarterial chemoembolization (TACE) with partial hepatectomy and partial hepatectomy alone

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000577314
Enrollment
100
Registered
2008-11-12
Start date
2001-07-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Following curative liver resection for HCC, 50%-90% of postoperative death is due to recurrent disease. Any neoadjuvant or adjuvant therapy which decreases or delays the onset of recurrence, improves the results of liver resection. However, there is still no effective neoadjuvant therapy or adjuvant therapy for HCC. We conducted a randomized controlled trial to evaluate the effect of preoperative TACE on survival after resection of HCC.

Interventions

For preoperative TACE group, a vascular catheter for TACE was inserted through the femoral artery using the Seldinger technique, and hepatic angiography was performed. The catheter’s tip was inserted selectively into the left and right hepatic artery, or the tumor-feeding artery when technically possible. An emulsion of 5-Fluorouracil (5-FU) (1 gm), mitomycin C (MMC) (20 mg), cisplatin (5 mg) and lipiodol 10-30 ml (1 to 2 ml/cm diameter of the tumor) was injected. Preoperative TACE was begun wit

For preoperative TACE group, a vascular catheter for TACE was inserted through the femoral artery using the Seldinger technique, and hepatic angiography was performed. The catheter’s tip was inserted selectively into the left and right hepatic artery, or the tumor-feeding artery when technically possible. An emulsion of 5-Fluorouracil (5-FU) (1 gm), mitomycin C (MMC) (20 mg), cisplatin (5 mg) and lipiodol 10-30 ml (1 to 2 ml/cm diameter of the tumor) was injected. Preoperative TACE was begun within 10 days after randomization. TACE was repeated up to 3 times at an interval of 4 to 9 weeks. Partial hepatectomy was performed within 8 weeks from the last session of TACE.

Sponsors

Eastern Hepatobiliary Surgery Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
16 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Preoperative diagnosis of HCC > or =5 cm in diameter suitable for partial hepatectomy

Exclusion criteria

Received other treatment before; history or presence of other malignancies; inadequate liver function

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026