Clinical trial · Interventional
A Prospective Control Study of Cidan Capsule Combined With TACE in Hepatocellular Carcinoma
A Prospective Randomized Control Study of Cidan Capsule Combined With Transcatheter Arterial Chemoembolization in Hepatocellular Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Hepatocellular carcinoma (HCC) is one of the most common malignances seen in different regions of the world. The 5-year risk of recurrence of HCC after resection has been reported to be as high as 70%. It has been proposed that best way to reduce recurrence is to search for improved adjuvant therapies. Especially for some postoperative patients who were identified with the risk factors for recurrence, several adjuvant therapies were often used, including TACE. Recently, a variety of Traditional Chinese Medicine combined with TACE for toxicity reduction and enhancing the efficacy have been investigated in the treatment of HCC. Cidan capsules are a formula containing more than ten types of plant extracts, and has been clinically used for \>10 years as a safe and nontoxic antitumor drug. However, the safy and efficacy of preventive therapy is still not clear. In this prospective control study, we enroll such HCC patients experienced operation and were identifed with high risk of recurrence. After a preventive TACE, the eligible patients were divided into two groups. One group will accept Cidan therapy and another will not. Under a basis of large sample, the safty and efficacy of Cidan combined with TACE in HCC patients will be investigated and analysed.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cidan capsule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cidan capsule
- description
- Patients who undergone operation and TACE were administered 1.35 g cidan capsules (Weida Pharmaceutical Co., Ltd., Beijing, China) three times a day for 3 months.
- interventionNames
- Drug: Cidan capsule
- type
- NO_INTERVENTION
- label
- Control group
- description
- Patients were only accepted operation and TACE.
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 3 years
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of HCC confirmed by pathology. * Liver function of Child-Pugh Class A or B. * no intrahepatic and extrahepatic metastasis. * Tumors had not invaded the portal vein, the hepatic vein trunk or the secondary branches. * Patients undergone operation were confirmed to have the following high-risk recurrence factors: Satellite nodules, Poor differentiation, Tumor diameter \> 5cm * No evidence of coagulopathy: platelet count \> 50 × 109/L and a prolonged prothrombin time of \< 5 seconds. * The patients would like to accept postoperative TACE. Exclusion Criteria: * Informed consent not available * Impaired liver function with either clinically detected ascites, hepatic encephalopathy, serum albumin \< 25g/L or bilirubin \> 50micromol/L * Renal impairment with creatinine \> 200micromol/L * Severe concurrent medical illness persisting \> 6 weeks after hepatectomy * History of other cancer * Pregnant women
References
Publications (1)
- DERIVEDZheng DH, Yang JM, Wu JX, Cheng SQ, Zhang SG, Wu D, Li AJ, Fu XH, Li X, Qi FC, Duan WH, Chen JH, Yang ZY, Liang L, Zeng JX, Zheng WD, Wu MC. Cidan Capsule in Combination with Adjuvant Transarterial Chemoembolization Reduces Recurrence Rate after Curative Resection of Hepatocellular Carcinoma: A Multicenter, Randomized Controlled Trial. Chin J Integr Med. 2023 Jan;29(1):3-9. doi: 10.1007/s11655-022-3537-4. Epub 2022 Aug 1. PMID 35915317