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The treatment of acute liver injury after interventional therapy for primary liver cancer by compound Sanghuangyin: a prospective, randomized controlled, single-center clinical study

The treatment of acute liver injury after interventional therapy for primary liver cancer by compound Sanghuangyin: a prospective, randomized controlled, single-center clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085111
Enrollment
Unknown
Registered
2024-05-31
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-06-03

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

Conditions

Liver Cancer

Interventions

Experimental group:After TACE/HAIC operation, the patient received two kinds of hepatoprotective drugs and compound Sang Huang Yin orally.
Control group:Two kinds of hepatoprotective drugs were routinely used after TACE/HAIC.

Sponsors

Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria (1) Meet the diagnostic criteria for liver cancer in the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition); (2) The tumor stage was CNLC stage ?b-?b; (3) In accordance with the requirements of TACE/HAIC in the Chinese Clinical Practice Guidelines for Transcatheter Chemoembolization for Hepatocellular Carcinoma (2023 edition) or the Chinese Expert Consensus on Intraarterial and Combination Therapy for Primary Hepatocellular Carcinoma; (4) Age between 18 and 80 years old, male and female; (5) Child-Pugh grade A or B (score = 7 points); (6) ECOG-PS score 0 ~ 2 points; (7) Voluntarily participate in and sign informed consent in person; (8) Subjects with hepatitis B surface antigen positive must routinely take oral antiviral drugs.

Exclusion criteria

Exclusion criteria: Exclusion criteria (1) Severe liver dysfunction, including severe aminotransferase elevation, jaundice, hepatic encephalopathy, refractory abdominal effusion, or hepatorenal syndrome; (2) Severe loss of coagulation function that cannot be corrected, history of gastrointestinal bleeding within 1 month before admission; (3) combined with active hepatitis or severe infection and cannot be treated at the same time; (4) The tumor is diffuse or distant, and the expected survival time is less than 3 months; (5) ECOG-PS score > 2, impaired fluid or multiple organ failure; (6) Renal dysfunction, serum creatinine > 176.8 µmol/L or creatinine clearance < 30 ml/min; (7) Peripheral blood white blood cells and platelets caused by chemotherapy drugs or other drugs were significantly reduced, with white blood cells < 3.0×109/L and platelets < 50×109/L and could not be corrected; (8) Patients with paralytic ileus; (9) The use of drugs with liver protection function, including Chinese herbal medicine and Chinese adult drugs, was not stopped 1 week before enrollment. The use of various hormones was not stopped 1 month before enrollment. (10) Patients allergic to the experimental drug or any other excipients or contrast agents; (11) Pregnant and lactating women; (12) Those who are unconscious, unable to express subjective discomfort symptoms and psychiatric patients; (13) Diseases and conditions that are not considered to be included by other researchers.

Design outcomes

Primary

MeasureTime frame
Liver function index: ALB, ALP, ALT, AST, A/G, GGT, TBIL;Serological indicators of liver fibrosis: HA, LN, PC-?, ?-C;

Secondary

MeasureTime frame
Postoperative hospitalization days;Blood routine index: hemoglobin, white blood cells, neutrophils absolute value, platelets;Indicators of coagulation function: APTT, PT, PTA, INR;Cytokine level;Satisfaction evaluation;Changes of clinical symptoms and signs;Time for liver function to return to normal levels;EORTC Quality of Life measurement Scale QLQ-C30 (V3.0), PS score, Child score;

Countries

China

Contacts

Public ContactJun Luo

Zhejiang Cancer Hospital

luojun1575@zjcc.org.cn+86 188 6841 9397

Outcome results

None listed

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