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Trial Title:
Regorafenib Alone or in Combined With Transcatheter Arterial ChEmoembolization in Treatment of Advanced Hepatocellular Carcinoma After First Line Targeted Therapy
NCT ID:
NCT05811481
Condition:
Hepatocellular Carcinoma
Transcatheter Arterial ChEmoembolization
Regorafenib
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
TACE
Description:
Transcatheter Arterial Chemoembolization
Arm group label:
Two treatment groups
Intervention type:
Drug
Intervention name:
Regorafenib
Description:
Regorafenib alone
Arm group label:
Treatment ate group
Arm group label:
Two treatment groups
Summary:
. 1 Clarify the difference in efficacy of regofinib combined with TACE compared with
second-line treatment of advanced liver cancer; 2. To evaluate the safety and prognostic
imaging factors of regorofenib in advanced second-line therapy; 3, to explore whether it
is necessary to increase the treatment of TACE in the second-line treatment of advanced
HCC.
Criteria for eligibility:
Study pop:
Patients with hepatocellular carcinoma
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
( - ) After pathological / clinical diagnosis of hepatocellular carcinoma or radical
resection of hepatocellular carcinoma; ( - ) CNLC Ⅲa Patients with intrahepatic
recurrence before (including a); ( - ) Previous failure of first-line systemic treatment;
( - ) Age: 18-75 years old; ( - ) Child-Pugh 7 points; ( - ) ECOG PS Grade 0-2; ( - ) At
least one measurable lesion in the liver.
Exclusion Criteria:
( - ) Known hepatobiliary tubular cell carcinoma and mixed cell carcinoma and
fibrolamellar cell carcinoma; ( - ) Previous (within 5 years) or concurrent other
incurable malignant tumors; ( - ) Having received local treatment, systemic chemotherapy,
radiotherapy other than TACE during the first-line systemic treatment; ( - ) During the
second-line systemic treatment, I also received local treatment, systemic chemotherapy,
radiotherapy other than TACE; ( - ) Serious uncontrollable systemic and other systemic
diseases, such as uremia, cardiovascular and cerebrovascular accidents; ( - ) Allergy to
any drug included in the study; ( - ) Pregnant or lactating women;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
FirstSunYetSen
Address:
City:
Guangzhou
Zip:
510200
Country:
China
Status:
Recruiting
Contact:
Last name:
WenBo Guo
Phone:
+8613922282028
Email:
patrickguo2008@163.com
Start date:
December 27, 2022
Completion date:
December 27, 2025
Lead sponsor:
Agency:
WenBo Guo
Agency class:
Other
Source:
First Affiliated Hospital, Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05811481
