Effect of Babaodan on Tumor Recurrence After Curative Resection of Hepatocellular Carcinoma

• Status: Not yet recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Hepatobiliary Surgery Hospital
• Collaborators: First Affiliated Hospital, Sun Yat-Sen University; Fujian Mengchao Hepatobiliary Hospital; Second Military Medical University; Shanghai Zhongshan Hospital; Sun Yat-sen University; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Xiamen Traditional Chinese Medicine Co., Ltd.
• Treatments: Liver Extracts

Criteria

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.