Applicability of 3D-HDRA in Patients With Primary Liver Cancer: A Randomized Controlled Trial
Phase 3
Recruiting
- Conditions
- Liver, Cancer of, Primary Resectable
- Interventions
- Registration Number
- NCT05701436
- Lead Sponsor
- Zhujiang Hospital
- Brief 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.
- Detailed Description
Data of Patients who received 3D-HDRA after primary liver cancer radical reaction and received Transarterial Chemoembolization #will be collected #excluding incomplete data.
The primary endpoint was the one-year disease-free survival(DFS) rate #Secondary endpoint was the adverse event.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 144
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description the test group Oxaliplatin The test group received postoperative conventional treatment combined with precise transarterial chemoembolization based on 3D-HDRA results. Precise transarterial chemoembolization at 1-month intervals for 4 months after surgery. the test group Doxorubicin The test group received postoperative conventional treatment combined with precise transarterial chemoembolization based on 3D-HDRA results. Precise transarterial chemoembolization at 1-month intervals for 4 months after surgery. the test group Lobaplatin The test group received postoperative conventional treatment combined with precise transarterial chemoembolization based on 3D-HDRA results. Precise transarterial chemoembolization at 1-month intervals for 4 months after surgery. the test group Cisplatin The test group received postoperative conventional treatment combined with precise transarterial chemoembolization based on 3D-HDRA results. Precise transarterial chemoembolization at 1-month intervals for 4 months after surgery. the test group Lobaplatin, Raltitrexed The test group received postoperative conventional treatment combined with precise transarterial chemoembolization based on 3D-HDRA results. Precise transarterial chemoembolization at 1-month intervals for 4 months after surgery. the control group Lobaplatin The control group received postoperative conventional treatment combined with Empirical transarterial chemoembolization. Empirical transarterial chemoembolization at 1-month intervals for 4 months after surgery. the control group Lobaplatin, Raltitrexed The control group received postoperative conventional treatment combined with Empirical transarterial chemoembolization. Empirical transarterial chemoembolization at 1-month intervals for 4 months after surgery. the test group Oxaliplatin, Leucovorin, fluorouracil The test group received postoperative conventional treatment combined with precise transarterial chemoembolization based on 3D-HDRA results. Precise transarterial chemoembolization at 1-month intervals for 4 months after surgery. the control group Oxaliplatin, Leucovorin, fluorouracil The control group received postoperative conventional treatment combined with Empirical transarterial chemoembolization. Empirical transarterial chemoembolization at 1-month intervals for 4 months after surgery. the control group Oxaliplatin The control group received postoperative conventional treatment combined with Empirical transarterial chemoembolization. Empirical transarterial chemoembolization at 1-month intervals for 4 months after surgery. the control group Doxorubicin The control group received postoperative conventional treatment combined with Empirical transarterial chemoembolization. Empirical transarterial chemoembolization at 1-month intervals for 4 months after surgery. the control group Cisplatin The control group received postoperative conventional treatment combined with Empirical transarterial chemoembolization. Empirical transarterial chemoembolization at 1-month intervals for 4 months after surgery.
- Primary Outcome Measures
Name Time Method The one-year DFS rate From the start date of the Treatment until date of the time of 1 year The one-year DFS rate is defined as the percentage of participants who have not accrued disease at the time of 1 year
- Secondary Outcome Measures
Name Time Method Adverse events From the beginning of therapy until the date of death from any cause(max 24 months) Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Trial Locations
- Locations (1)
Zhujiang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China