NCT06261138

Survival Analysis: TACE vs. Combination Therapy in HCC

Survival Analysis of TACE Monotherapy vs. Combination Therapy in BCLC B and C Stage Hepatocellular Carcinoma: A Retrospective Cohort Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 279 (actual)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This retrospective observational study aimed to assess potential improvements associated with systemic therapies in patients receiving transarterial chemoembolization (TACE) for initially unresectable HCC.

Detailed description

Standard treatments provide limited benefits for patients with intermediate or advanced hepatocellular carcinoma (HCC). Recently, recommendations on multimodal treatment regimens for patients with locally advanced HCC have attracted much attention. Therefore, this retrospective research was designed to evaluate the clinical outcomes of TACE alone or in combination with immune and targeted therapy in the primary treatment for patients with intermediate to advanced stage HCC.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Transarterial chemoembolization	A 5-French RH catheter was then introduced to the celiac artery, superior mesenteric and artery common hepatic artery for angiography to determine tumor location, quantity, size, and vascularity. After confirmation by C-arm cone-beam computed tomography (CBCT), chemoembolization was administered by superselective catheterization of the branches of the tumor-feeding arteries using a 2.8-French coaxial microcatheter. For cTACE, oxaliplatin, raltitrexed and an emulsion containing idarubicin and ethiodized oil were infused for over 20 minutes, followed by combined embolization with blank embolic microspheres. For DEB-TACE, DC/LC Beads® (Biocompatibles, Farnham, Surrey, UK), as drug carriers and embolic materials, were loaded with doxorubicin hydrochloride and mixed with nonionic contrast medium. Real-time assessment of embolization was performed with the assistance of CBCT.
OTHER	Systemic treatment	sorafenib (Bayer HealthCare, Berlin, Germany), lenvatinib (Eisai, Tokyo, Japan), apatinib (Hengrui Pharmaceuticals, Lianyungang, China) and donafenib (Zelgen Biopharmaceuticals, Suzhou, China), while a minority of patients received bevacizumab (Innovent Biologics, Suzhou, China). sintilimab (Innovent Biologics, Suzhou, China), toripalimab (Junshi Biosciences, Suzhou, China), camrelizumab (Hengrui Pharmaceuticals, Lianyungang, China), tislelizumab (BeiGene, Shanghai, China), pembrolizumab (Merck Sharp \& Dohme, NewJersey, USA), nivolumab (Bristol Myers Squibb, New York, USA), atezolizumab (Roche, Basel, Switzerland) and envafolimab (Alphamab Biopharmaceuticals, Suzhou, China).

Timeline

• Start date: 2019-02-01
• Primary completion: 2023-03-31
• Completion: 2023-10-31
• First posted: 2024-02-15
• Last updated: 2024-02-15

Locations

1 site across 1 country: China