Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-24 @ 11:13 PM
NCT ID:
NCT03515369
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03515369
Study Brief:
Protocol Section:
NCT03515369