Hepatocellular Carcinoma Resectable
Conditions
Brief summary
This Randomized Controlled Trial was to clarity the clinical feasibility of PDOX results in guiding the drug use of interventional chemotherapy after primary liver cancer surgery.
Detailed description
Data of Patients who received PDOX 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.
Interventions
DRUGOxaliplatin
130 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.
DRUGDoxorubicin
20 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.
DRUGLobaplatin
50 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.
DRUGCisplatin
50 mg per square body surface area was used for monthly transhepatic arterial infusions.
Oxaliplatin(130 mg per square body surface area), Leucovorin(400 mg per square body surface area), and fluorouracil(2800 mg per square body surface area) were used for monthly transhepatic arterial. infusions
Lobaplatin(50 mg per square body surface area) and Raltitrexed(3 mg per square body surface area) were used for monthly transhepatic arterial infusions.
Sponsors
Zhujiang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The test group received postoperative conventional treatment combined with precise transarterial chemoembolization based on PDOX results, and the control group received postoperative conventional treatment combined with empirical transarterial chemoembolization with Doxorubicin.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Undergone radical surgical resection. 2. Aged 18-75. 3. Patients voluntarily cooperated with the study and signed an informed consent form. 4. Histopathologically diagnosed hepatocellular carcinoma. 5. Patients with R0 resection confirmed by imaging and pathology (no residual lesions and complete tumor resection after radical surgery). 6. Child-Pugh score of 5-7 (A or B), patients with a score of 7 must be free of ascites. 7. ECOG physical fitness status score of 0-1. 8. No serious heart, lung, or renal dysfunction
Exclusion criteria
1. Unable to provide specimens for PDOX testing. 2. Patients with recurrent liver cancer. 3. Developing two or more types of tumors simultaneously. 4. Patients with existing extrahepatic distant metastases. 5. Treatment with other experimental drugs or other interventions after radical resection. 6. Patients with other malignant tumors that have not been cured within 5 years. 7. Patients with non-radical resections (R1 and R2 resections). 8. Patients with residual or recurrent lesions detected on imaging within 1-2 months after surgery. 9. Died within 1 month after surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactMingxin Pan, Prof.
Outcome results
None listed