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Efficacy and safety of DEB-TACE in the treatment of primary hepatocellular carcinoma: multicenter, randomized, controlled clinical study

Efficacy and safety of DEB-TACE in the treatment of primary hepatocellular carcinoma: multicenter, randomized, controlled clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030057
Enrollment
Unknown
Registered
2020-02-22
Start date
2020-03-01
Completion date
Unknown
Last updated
2020-03-30

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

Conditions

primary hepatocellular carcinoma

Interventions

experimental group:Callispheres carrier drug microsphere
control group:traditional iodide oil embolization (cTACE)

Sponsors

The First Affiliated Hospital of University of Science and Technology of China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Patients with primary hepatocellular carcinoma confirmed clinically or pathologically; (2) Aged 18-80 years, with an expected survival period of >= 3 months; (3) The number of tumors is 5 cm; or 2-3, at least one> 3 cm); (4) Child-Pugh grade A or B for liver function; ECOG performance status score = 3.0 x 10^9 / L; platelet count >= 50 x 10^9 / L; (7) The international normalized ratio (INR) of prothrombin time <= 2.3 or prolonged prothrombin time (PT) <=3 seconds; (8) Serum creatinine is less than 1.5 times the upper limit of normal; (9) Patients and / or family members agree to participate in clinical trials and sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Diffuse liver cancer; (2) Bile duct cell carcinoma; (3) Patients with grade III-IV portal vein tumor thrombus; (4) Patients who have undergone ablation surgery; (5) The tumor volume is too large, such as more than 2/3 of the liver volume; (6) Uncorrectable coagulation dysfunction, who have obvious bleeding tendency; (7) Severe liver cirrhosis, ascites above moderate amount; (8) Serious heart, lung, kidney and other important organ diseases and dysfunction; (9) Uncontrolled infections such as HIV, sepsis, biliary infections, liver abscesses or other active infections; (10) Pregnant and lactating women; (11) History of organ transplantation; (12) CT / MRI cannot be performed; (13) Subjects participating in other clinical trials at the same time.

Design outcomes

Primary

MeasureTime frame
MRI or CT of the liver;AFP;blood routine;liver function;ECOG score;

Countries

China

Contacts

Public ContactLv Weifu

The First Affiliated Hospital of University of Science and Technology of China

lwf99@126.com+86 13955102987

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026