Last updated: March 1, 2023
Sponsor: Zhujiang Hospital
Overall Status: Active - Recruiting
Phase
3
Condition
Digestive System Neoplasms
Liver Cancer
Primary Biliary Cholangitis
Treatment
N/AClinical Study ID
NCT05701436
2022-KY-277-01
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients voluntarily cooperated with the study and signed an informed consent form.
- Any gender, age 18 or older, 75 or younger.
- Patients who need to confirm the maximum tumor load (the maximum diameter of a singletumor lesion) before performing radical surgery; patients with a confirmed diagnosisof primary liver cancer after postoperative pathological histological examination.
- Patients with R0 resection confirmed by imaging and pathology (no residual lesions andcomplete tumor resection after radical surgery).
- Child-Pugh score of 5-7 (A or B), patients with a score of 7 must be free of ascites.
- ECOG physical fitness status score of 0-1.
- Women of childbearing age with a negative pregnancy test and willing to use effectivecontraception for the duration of the study.
Exclusion
Exclusion Criteria:
- Patients with recurrent liver cancer.
- Patients with existing extrahepatic distant metastases (including local lymph nodemetastases or distant organ metastases: e.g., lung, brain, bone, etc.) at the time ofdiagnosis.
- Treatment with other experimental drugs or other interventions after radicalresection.
- Patients with other malignant tumors that have not been cured within 5 years.
- Patients with non-radical resections (R1 and R2 resections).
- Patients with residual or recurrent lesions detected on imaging within 1-2 monthsafter surgery.
- Patients in whom death occurred within 30 days after surgery.
Study Design
Total Participants: 144
Study Start date:
September 01, 2022
Estimated Completion Date:
March 01, 2026
Study Description
Connect with a study center
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong
ChinaActive - Recruiting
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