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 @ 4:04 PM
Ignite Modification Date:
2025-12-24 @ 4:04 PM
NCT ID:
NCT01717066
Eligibility Criteria:
Inclusion Criteria:
* 18-75 years old,male and female
* Mainly based on the criteria for liver cancer TNM stage I and II (edition 7) and BCLC stage A, the following needs to be satisfied:
1. individual tumor larger than or equal to 2 cm and smaller than or equal to 10 cm in the maximum diameter
2. multiple tumors with no more than three tumors
3. No macroscopic tumor embolus
* ECOG performance state is 0-1
* Child-Pugh grade is A
* The clinical review confirms the absence of recurrence within 8 weeks before the enrollment
* Sign the informed consent
Exclusion Criteria:
* Pregnant and breast-feeding women
* Patients with severe diseases in the brain, heart,lungs, kidneys and hematological system
* Patients who have received other anti-tumor therapies before the surgery (including liver transplantation, TACE, local tumor ablation, chemotherapy, radiotherapy, molecular targeted therapy and other anti-tumor therapy)
* DDS chemotherapy pump placed in the portal vein during the surgery
* Patients who are participating in other drug trials
* Patients known or suspected to be allergic to ginsenoside, with a history of allergy to biological preparations, allergic constitution or currently in an allergic state;
* With active severe clinical infection
* Epilepsy episode which needs drug therapy
* With a history of allotransplantation;
* With a previous history of tumor in other systems, but except for:
1. Carcinoma in situ of cervix
2. Basal cell carcinoma after treatment,Superficial bladder cancer (Ta, Tis and T1
3. Any cancer after curative treatment no less than three years ago
* Patients with signs or a history of bleeding diathesis
* Patients currently receiving kidney dialysis
* A history of bleeding in the gastrointestinal tract within 30 days, or severe gastroesophageal varices with red signs; with a history of gastroesophageal variceal hemorrhage
* Recurrent HCC
* Patients unable to take drug orally
* Patients inappropriate to participate in the trial upon the investigator's judgment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01717066
Study Brief:
Protocol Section:
NCT01717066