Clinical trial · Interventional
Effect of Babaodan on Tumor Recurrence After Curative Resection of Hepatocellular Carcinoma
Effect of Babaodan in Preventing Tumor Recurrence After Hepatectomy for Hepatocellular Carcinoma: a Multicenter, Randomized, Placebo-controlled, Double-blind Trial
NCT03515369CI-TRIAL-00032772unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The aim of this study is to evaluate the effect of traditional Chinese medicine Babaodan on tumor recurrence of hepatocellular carcinoma after curative resection, as well as the safety of this treatment
Conditions
Conditions (2)
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 |
| Tumor Recurrence | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Babaodan oral capsule | Drug | — | UNRESOLVED |
| Placebo oral capsule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hepatectomy plus Babaodan
- description
- Surgical removal of all lesions and take Babaodan oral capsule after operation
- interventionNames
- Drug: Babaodan oral capsule
- type
- PLACEBO_COMPARATOR
- label
- Hepatectomy plus Placebo
- description
- Surgical removal of all lesions and take Placebo oral capsule after operation
- interventionNames
- Drug: Placebo oral capsule
Primary outcomes (1)
- measure
- 3-year disease free survival
- timeFrame
- 3-year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion criteria: 1. age ≥18 years and ≤75 years 2. male or female patients 3. tumor of BCLC A or B stage (≤3 nodules), and was assessed to be curative resected 4. hepatocellular carcinoma confirmed by postoperative pathology, received R0 resection 5. without tumor thrombus 6. without extrahepatic metastasis 7. KPS score ≥80 8. Child-Pugh A liver function 9. the expected postoperative survival time ≥12 weeks 10. the latest laboratory tests met the following requirements before entering the group: 1) hemoglobin ≥8.5g/dl; 2) neutrophils count ≥1,000/mm3; 3) platelet count ≥50,000/ul; 4) total bilirubin ≤2 upper limit of normal; 5) ALT and AST ≤3 upper limit of normal; 6) serum urea nitrogen and creatinine ≤1.5 upper limit of normal 11. agree to sign the informed consent Exclusion criteria: 1. \>3 tumor nodules 2. history of HCC 3. history of other tumors, except: 1) in situ carcinoma of cervix; 2) treated basal cell carcinoma; 3) superficial bladder cancer (Ta、Tis and T1); 4) any cancer that received radical treatment more than 3 years 4. with serious diseases of heart, brain, lung, kidney and blood system 5. received preoperative anti-cancer treatment 6. received radiotherapy or chemotherapy during the operation 7. pregnant or lactating women 8. receiving other clinical trials 9. history of allogeneic organ transplantation 10. patients known or suspected to be allergic to Babaodan, have allergy history of biological agents, have allergic constitution or being allergic 11. patients with hemorrhagic tendency or history of gastrointestinal bleeding within 30 days; severe esophageal varices or have history of esophageal variceal hemorrhage 12. cannot take medicine orally 13. have HIV infection or AIDS related diseases 14. have a history of mental illness or behavioral abnormality, which is assessed not suitable for clinical trials.
References
Publications (0)
Data not yet available
No reference posted for this study.