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A Prospective Randomized Controlled Study on the Effects of Bovis Cultured in Vitro on Embolization Syndrome and Survival after TACE for Liver Cancer

A Prospective Randomized Controlled Study on the Effects of Bovis Cultured in Vitro on Embolization Syndrome and Survival after TACE for Liver Cancer - Effect of Calculus Bovis Cultured in Vitro on Embolization Syndrome and Survival after TACE for Liver Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068009
Enrollment
Unknown
Registered
2023-02-03
Start date
2023-02-03
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

HCC

Interventions

control group:Basic treatment + TACE
Test group:Basic treatment + TACE + Bezoar cultured in vitro

Sponsors

Changhai Hospital, Navy Military Medical University, Shanghai
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. HCC diagnosed as unresectable according to the imaging technology and/or biopsy guidelines of the Diagnostic and Treatment Guidelines for Primary Liver Cancer (2022) 2. Unable or unwilling to accept palliative surgery, with at least one measurable lesion, and willing to accept TACE treatment 3. Barcelona stage: BCLC-B or C 4. Child-Pugh A5-B7 5. Age: 18-75 6. Within 1 week before enrollment, the performance score of the Eastern Cancer Cooperation Group (ECOG) was 0-1 7. Good organ and bone marrow function: (1) Hemoglobin >= 9.0g/dL (2) White blood cell count >= 3.0 x 10^9/ µ L (3) Platelet count >= 75 x 10^9/ µ L (4) Total bilirubin = 2.8g/dL (7) International normalized ratio (INR) = 30mL/min 8. The expected survival period is more than 12 weeks. 9. Voluntarily accept the treatment of this study protocol and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Complicated with heart, brain, kidney, lung and other organ diseases; 2. The formation of tumor thrombus in the main portal vein, tumor thrombus in the bile duct and collateral vessels were less; 3. Severe varices of gastric fundus and esophageal and cardiac veins, severe portal hypertension, and risk of rupture and bleeding; 4. Systemic infection sepsis, liver abscess; 5. Liver function was classified as Grade C by Childpugh; 6. Abnormal liver function caused by severe cirrhosis, or obvious ascites and jaundice; 7. Tumor accounts for 70% or more of the whole liver; 8. Allergic constitution, or allergy to the drugs involved in this study; 9. Subjects have received any bezoar medication within two weeks before enrollment; 10. Have a history of other anti-tumor drugs or anti-tumor non-drug treatment in the past month.

Design outcomes

Primary

MeasureTime frame
Objective efficacy index;Inflammatory indicators;Biochemical index;

Secondary

MeasureTime frame
Progression-free survival;

Countries

China

Contacts

Public ContactZhai Xiaofeng

Changhai Hospital, Navy Military Medical University, Shanghai

zhaixfch@163.com+86 139 1759 5511

Outcome results

None listed

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