Overview

Applicability of 3D-HDRA in Patients With Primary Liver Cancer: A Randomized Controlled Trial

Status:
Recruiting
Trial end date:
2026-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Zhujiang Hospital
Treatments:
Cisplatin
Doxorubicin
Fluorouracil
Leucovorin
Oxaliplatin
Raltitrexed
Criteria
Inclusion Criteria:

1. Patients voluntarily cooperated with the study and signed an informed consent form.

2. Any gender, age 18 or older, 75 or younger.

3. 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.

4. Patients with R0 resection confirmed by imaging and pathology (no residual lesions and
complete tumor resection after radical surgery).

5. Child-Pugh score of 5-7 (A or B), patients with a score of 7 must be free of ascites.

6. ECOG physical fitness status score of 0-1.

7. Women of childbearing age with a negative pregnancy test and willing to use effective
contraception for the duration of the study.

Exclusion Criteria:

1. Patients with recurrent liver cancer.

2. 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.

3. Treatment with other experimental drugs or other interventions after radical
resection.

4. Patients with other malignant tumors that have not been cured within 5 years.

5. Patients with non-radical resections (R1 and R2 resections).

6. Patients with residual or recurrent lesions detected on imaging within 1-2 months
after surgery.

7. Patients in whom death occurred within 30 days after surgery.