NCT05703750|Unknown
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Sponsor study identifier
observational
228
1 country
2
Study Start
May 4, 2023
Actual (reported)Primary Completion
June 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to discuss the prognostic value of CEPH among HCC patients underwent TACE treatment, its impact on overall survival, and try to stratify patient cohorts for a better treatment strategy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 19, 2023
Actual (reported)January 30, 2023
Actual (reported)May 4, 2023
Actual (reported)June 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Overall Survival(OS)
The OS is defined as the time from the initiation of any treatment to death due to any cause.
up to approximately 2 years
Objective response rate(ORR) per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
up to approximately 2 years
Progression free survival(PFS) per mRECIST
up to approximately 2 years
CEPH was defined when at least one following factor was present: 1) esophageal/gastric varices on upper endoscopy or CT imaging, 2) ascites requiring diuretic treatment, 3) splenomegaly (largest diameter on CT \>12 cm) with a low platelet count (\<100,000/mm3).
Non-CEPH was defined when none of the following factor was present: 1) esophageal/gastric varices on upper endoscopy or CT imaging, 2) ascites requiring diuretic treatment, 3) splenomegaly (largest diameter on CT \>12 cm) with a low platelet count (\<100,000/mm3).
TACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE); Systemic therapy: PD-1/PD-L1 inhibitors, VEGF-TKI/bevacizumab, PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab, radiotherapy or chemotherapy.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients with HCC treated with TACE ± Systemic Treatment from June 2006 to December 2021.
Gao-Jun Teng
Nanjing, China
Xiaolong Qi
Nanjing, China
Hernandez-Gea V, Turon F, Berzigotti A, Villanueva A. Management of small hepatocellular carcinoma in cirrhosis: focus on portal hypertension. World J Gastroenterol. 2013 Feb 28;19(8):1193-9. doi: 10.3748/wjg.v19.i8.1193.
Muller L, Hahn F, Mahringer-Kunz A, Stoehr F, Gairing SJ, Foerster F, Weinmann A, Galle PR, Mittler J, Pinto Dos Santos D, Pitton MB, Duber C, Fehrenbach U, Auer TA, Gebauer B, Kloeckner R. Prevalence and clinical significance of clinically evident portal hypertension in patients with hepatocellular carcinoma undergoing transarterial chemoembolization. United European Gastroenterol J. 2022 Feb;10(1):41-53. doi: 10.1002/ueg2.12188. Epub 2021 Dec 16.
Gao-Jun Teng, M.D.
Zhongda hospital, Southeast university, Nanjing, China
Xiaolong Qi, M.D.
Zhongda hospital, Southeast university, Nanjing, China
First Submitted
January 19, 2023
First Posted
January 30, 2023
Study Start
May 4, 2023
Actual (reported)Primary Completion
June 30, 2023
Estimated (date passed)Assessing the Prognosis of TACE in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies for HCC by Using Clinical and Imaging Biomarkers
Efficacy and Safety of TACE in Combination With ICIs for HCC: a Real-world Study
Contact the study team to confirm eligibility.
Faitot F, Allard MA, Pittau G, Ciacio O, Adam R, Castaing D, Cunha AS, Pelletier G, Cherqui D, Samuel D, Vibert E. Impact of clinically evident portal hypertension on the course of hepatocellular carcinoma in patients listed for liver transplantation. Hepatology. 2015 Jul;62(1):179-87. doi: 10.1002/hep.27864. Epub 2015 May 20.
European Association For The Study Of The Liver; European Organisation For Research And Treatment Of Cancer. EASL-EORTC clinical practice guidelines: management of hepatocellular carcinoma. J Hepatol. 2012 Apr;56(4):908-43. doi: 10.1016/j.jhep.2011.12.001. No abstract available.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 31, 2023
Record last verified: 2023-05
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Source: ClinicalTrials.gov.
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