Skip to content

Portal vein I125 particle strips combined with portal vein stent implantation combined with transarterial chemoembolization (TACE) and external radiotherapy (EBRT) combined with TACE in the treatment of CNLC IIIa HCC with type III PVTT: a multicenter, prospective study

Portal vein I125 particle strips combined with portal vein stent implantation combined with transarterial chemoembolization (TACE) and external radiotherapy (EBRT) combined with TACE in the treatment of CNLC IIIa HCC with type III PVTT: a multicenter, prospective study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043419
Enrollment
Unknown
Registered
2021-02-16
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-06-07

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

Conditions

Hepatocellular carcinoma

Interventions

Group A:Portal vein radioactive I125 implantation + portal vein stent implantation plus TACE
Group B:EBRT plus TACE

Sponsors

Fujian Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Confirmed by histopathology and/or meets the clinical diagnostic criteria of HCC (typical imaging features). (2) Intrahepatic tumors meet the following criteria: a. The number and size of semi-liver tumors on the side of PVTT origin are not limited, the number of semi-liver tumors on the side of non-PVTT origin + the maximum tumor diameter = 3.0 x 10^9/L, PLT >= 50 x 10^9/L, Hb > 90g/L; INR 40% of the standard liver volume; renal function: blood CREA does not exceed 1.5 times the upper limit of normal. (6) ECOG score 0-2 points. (7) The estimated survival time is > 3 months. (8) Age 18-70 years old, regardless of gender. (9) Willing to participate in this study, sign an informed consent form and promise to cooperate in completing the implementation of this study plan, including scheduled follow-up, treatment plan, laboratory examination or other research steps.

Exclusion criteria

Exclusion criteria: (1) Those with Child-Pugh score >= 8 or Child-Pugh B (7 points) still cannot reach Child-Pugh A after hepatoprotective treatment. (2) The coagulation function is severely decreased and cannot be corrected. (3) Patients with active hepatitis or severe infection who cannot be treated at the same time. (4) Patients with distant metastasis of the tumor, and the estimated survival time is less than 3 months. (5) Those with cachexia or multiple organ failure. (6) The proportion of tumors in the whole liver is >= 70%. (7) Peripheral blood WBC and PLT decreased significantly, WBC 2mg/dl (176.8umol/L) or creatinine clearance rate 2, receiving hemodialysis or peritoneal dialysis, human immune deficiency Viral (HIV) infection, uncontrollable or difficult-to-control diabetes, active gastrointestinal bleeding without definite treatment within 30 days, history of alcohol or drug abuse within 3 months, history of unstable mental illness. (13) Female patients who are pregnant, lactating or planning to conceive.

Design outcomes

Primary

MeasureTime frame
OS;

Secondary

MeasureTime frame
PFS;ORR;

Countries

China

Contacts

Public ContactJingfeng Liu

Fujian Cancer Hospital

drjingfeng@126.con+86 13905029580

Outcome results

None listed

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