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NCT05701436
Applicability of 3D-HDRA in Patients With Primary Liver Cancer: A Randomized Controlled Trial
Conditions: Liver, Cancer of, Primary Resectable
Sex: All
Ages: 18 Years – 75 Years
Phase: PHASE3
Enrollment: 144
Sponsor: Zhujiang Hospital
Location: China
Summary
This Randomized Controlled Trial was to clarity the clinical feasibility of 3D-HDRA results in guiding the drug use of interventional chemotherapy after primary liver cancer surgery.
Eligibility Criteria
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 single tumor lesion) before performing radical surgery; patients with a confirmed diagnosis of primary liver cancer after postoperative pathological histological examination.Patients with R0 resection confirmed by imaging and pathology (no residual lesions and complete 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 effective contraception for the duration of the study.Exclusion Criteria:Patients with recurrent liver cancer.Patients with existing extrahepatic distant metastases (including local lymph node metastases or distant organ metastases: e.g., lung, brain, bone, etc.) at the time of diagnosis.Treatment with other experimental drugs or other interventions after radical resection.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 months after surgery.Patients in whom death occurred within 30 days after surgery.
Source: ClinicalTrials.gov (NCT05701436). StuddyBuddy aggregates publicly available trial information.