Hepatocellular Carcinoma Clinical Trial
Official title:
A Prospective, Randomized, Multicenter Study of Comparison of TACE Combination With and Without EBRT for HCC Which is Unresectable But Confined to the Liver
This clinical trial is a prospective, randomized, controlled and multicenter study.And the trial is going to better control intrahepatic tumors for hepatocellular carcinoma(HCC) patients who meet the inclusion criterion.The patients were divided into two groups, the group A by TACE and the other group B by external- beam radiotherapy(EBRT) after 2 times TACE. Then the therapeutic effects and toxicities of TACE and EBRT are evaluated during the follow-up period. The study design plans to enroll 300 patients, and each group includes 150 cases.
Enrolled HCC patients met the inclusion criterion, in the late or advanced stage,tumor
confined in intrahepatic( meet the tolerance-dose for the liver), without cancer embolus in
main branch of portal vein, without extrahepatic metastasis and the number of tumor was≤3.
Eligible participants will be randomly assigned to the group A by TACE and the other group B
by EBRT after 2 times TACE.
TACE group: The frequency of treatment is determined based on the disease condition for
patients who are randomly assigned to group of TACE.TACE is performed via an injection into
the hepatic artery of agents by puncturing the common femoral artery, and micro-embolization
superselective catheterization is preferred.Adriamycin(30 to 60mg) is considered as basic
chemotherapy drugs in the process of transcatheter endovascular perfusion.The dose of fluid
lipiodol was determined by diameter and blood supply type of HCC,generally 5-20ml, and no
more than 30ml once.The boundary is considered whether there are large amounts of lipiodol to
deposit in the tumor and tiny branches shadow of portal veins in paracarcinoma under
fluoroscopic guidance. Embolizing agents(gelatin sponge particles 350um-560um) are added
after lipiodol emulsion embolization.It has a possibility of observeation alone if tumor
achieves a complete response after two times TACE.
EBRT group: Patients who were randomized to the radiotherapy group start radiotherapy 3-5
weeks after the completion 2 times TACE and began to undergo radiation. Radiotherapy
equipment is based on the conditions of the cooperative units. 3-dimensional conformal
radiation therapy(3-DCRT), intensity-modulated radiation therapy(IMRT) or Image-Guided
Radiotherapy(IGRT) will be opted based on hospital. IGRT can also be used via helical
tomotherapy, Rapid Arc or Volumetric Modulated Arc Therapy(VMAT). The target volume should
include the visible tumor.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04209491 -
Interest of the Intervention of a Nurse Coordinator in Complex Care Pathway
|
||
Completed |
NCT03963206 -
Cabozantinib toLERANCE Study in HepatoCellular Carcinoma (CLERANCE)
|
Phase 4 | |
Completed |
NCT03268499 -
TACE Emulsion Versus Suspension
|
Phase 2 | |
Recruiting |
NCT05263830 -
Glypican-3 as a Prognostic Factor in Patients With Hepatocellular Carcinoma Treated by Immunotherapy
|
||
Recruiting |
NCT05044676 -
Immune Cells as a New Biomarker of Response in Patients Treated by Immunotherapy for Advanced Hepatocellular Carcinoma
|
||
Recruiting |
NCT05095519 -
Hepatocellular Carcinoma Imaging Using PSMA PET/CT
|
Phase 2 | |
Recruiting |
NCT05497531 -
Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers
|
N/A | |
Completed |
NCT05068193 -
A Clinical Trial to Compare the Pharmacokinetics and Bioequivalence of "BR2008" With "BR2008-1" in Healthy Volunteers
|
Phase 1 | |
Active, not recruiting |
NCT03781934 -
A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations
|
Phase 1/Phase 2 | |
Terminated |
NCT03655613 -
APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04242199 -
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT04401800 -
Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma
|
Phase 2 | |
Withdrawn |
NCT05418387 -
A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona
|
N/A | |
Active, not recruiting |
NCT04039607 -
A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma
|
Phase 3 | |
Terminated |
NCT03970616 -
A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma
|
Phase 1/Phase 2 | |
Recruiting |
NCT03642561 -
Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE
|
Phase 2/Phase 3 | |
Recruiting |
NCT06239155 -
A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04118114 -
Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors
|
Phase 2 | |
Completed |
NCT03222076 -
Nivolumab With or Without Ipilimumab in Treating Patients With Resectable Liver Cancer
|
Phase 2 |