Hepatocellular carcinoma
Conditions
Interventions
Control group:TACE therapy (Transcatheter Arterial Chemoembolization) + formulated granule placebo
Chinese herbal decoction group:TACE therapy + Shenling Baizhu Powder Decoction
High dose group of formula granules:TACE therapy + high-dose Shenling Baizhu Powder formula granules
Medium-dose group of formula granules:TACE therapy + Chinese herbal decoction (0.8 times the dose of Shenling Baizhu Powder formula granules)
Chinese medicine decoction group:TACE therapy combined with Chinese herbal decoction at 0.6 times the dose of Shenling Baizhu Powder formula granules.
Sponsors
Shenshan Medical Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Shanwei, Guangdong Province
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria and staging system outlined in the "Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition)" issued by the National Health Commission of the People's Republic of China with confirmed stage IIb IIIa or IIIb disease; (2) Comply with diagnostic criteria for Spleen Deficiency with Dampness Exuberance Syndrome as defined in both the "Clinical Research Guidelines for New Chinese Medicines (Trial)" and "Diagnostic Differentiation of TCM Syndromes (Second Edition)" : Primary symptoms: 1)Mental fatigue abdominal distension poor appetite 2) Secondary symptoms: Heavy sensation in head/body weight loss sallow complexion loose stools nausea/vomiting tendency 3) Tongue/pulse signs: Pale or swollen tongue with white greasy coating; soggy or slow pulse Diagnosis requires either: - 2 primary symptoms OR - 1 primary symptom plus 2 secondary symptoms Combined with characteristic tongue/pulse manifestations confirmed by TCM syndrome differentiation. (3) Have indications for transarterial chemoembolization (TACE) treatment but currently decline surgical intervention; (4) Possess at least one measurable lesion (=2 cm on conventional CT or =1 cm on spiral CT/MRI); (5) Aged 18-65 years any gender with independent behavioral capacity; (6) Hematological parameters meeting: - Platelet count >100×10^9/L - Hemoglobin >80 g/L - Prothrombin time prolongation 28 g/L - Bilirubin 60; (8) Voluntarily accept study protocol with good compliance able to maintain medication adherence and provide reliable follow-up contact information (telephone/address); (9) Capable of understanding and voluntarily signing the Informed Consent Form.
Exclusion criteria
Exclusion criteria: (1) Secondary liver cancer or double primary cancer; (2) Contraindications to TACE (Transcatheter Arterial Chemoembolization) therapy; (3) Comorbidities with severe primary diseases of major organs or mental disorders deemed unable to tolerate treatment; (4) Presence of distant metastasis with an expected survival period <3 months; (5) Previous receipt of surgery radiotherapy chemotherapy or systemic therapy prior to medication with =4 weeks interval between treatment completion and randomization; (6) Pregnant or lactating women or female patients of childbearing potential not using contraception; (7) History of substance abuse or alcohol addiction; (8) Known history of grade III or IV allergic reactions to any investigational therapeutic agents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine (TCM) Syndrome Efficacy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of Solid Tumors;Tumor Markers;Liver Function Tests;The four indicators of hepatic fibrosis;Immune Index Testing;Karnofsky Performance Status (KPS);Metabolite Identification and Quantification; | — |
Countries
CHINA
Contacts
Public ContactLin Yujie
Shenshan Medical Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Shanwei, Guangdong Province
Outcome results
None listed