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Randomized comparative study of HCC with PVTT treated by interventional therapy and proton heavy ion radiotherapy and sorafenib combined with or without endovascular implantation of Iodine?125(125 I) seeds

Multidisciplinary diagnosis and treatment of liver cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17012083
Enrollment
Unknown
Registered
2017-07-22
Start date
2017-09-30
Completion date
Unknown
Last updated
2017-07-24

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

Conditions

Hepatocellular carcinoma

Interventions

A:endovascular implantation of Iodine?125(125 I) seeds
B1:TACE
B2:endovascular implantation of Iodine-125(125 I) seeds and TACE
B3:endovascular implantation of Iodine?125(125 I) seeds and TACE and sorafenib
C1:Portal stent implantation
C2:endovascular implantation of Iodine?125(125 I) seeds and Portal stent implantation
C3:endovascular implantation of Iodine?125(125 I) seeds and Portal stent implantation and sorafenib
D1:Proton heavy ion radiotherapy
D2:endovascular implantation of Iodine?125(125 I) seeds and Proton heavy ion radiotherapy
D3:endovascular implantation of Iodine?125(125 I) seeds and Proton heavy ion radiotherapy and sorafenib

Sponsors

Department of General Surgery, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) according to the clinical classification standard of Barcelona Clinic Liver (cancer), HCC patients who can not undergo surgical resection, liver transplantation or ablation; (2) PVTT was confirmed by imaging, and there was no history of the treatment of portal vein tumor thrombus at the same time; (3) Child-Pugh grade A or B; (4) without intrahepatic and extrahepatic metastasis; (5) normal coagulation function; (6) informed consent was obtained.

Exclusion criteria

Exclusion criteria: (1) the L branches of the left and right portal vein of the liver were completely occluded; (2) the tumor thrombus extends into the superior mesenteric vein or the splenic vein; (3) with TACE contraindications: tumor volume accounted for more than 70% of the liver; severe cardiovascular, pulmonary disease and severe renal insufficiency; liver function damage, such as severe jaundice, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) by more than 3 times higher than the normal value, difficult to control ascites, Child C grade; obvious disturbances of blood coagulation and bleeding tendency.

Design outcomes

Primary

MeasureTime frame
prognosis;—

Secondary

MeasureTime frame
Tumor thrombus size;tumor size;Recanalization of portal vein;—

Countries

China

Contacts

Public ContactJun Shen

Department of General Surgery, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

shenjun@xinhuamed.com.cn+86 13651628626

Outcome results

None listed

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