Applicability of PDOX in Patients With Primary Liver Cancer: A Randomized Controlled Trial

Study Overview
=================
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.

Official Title
-----------------
Applicability of Patient Derived Orthotopic Xenograft (PDOX) in Patients With Primary Liver Cancer: A Randomized Controlled Trial

Conditions
-----------------
Hepatocellular Carcinoma Resectable

Intervention / Treatment
-----------------
* Drug: Oxaliplatin
* Drug: Doxorubicin
* Drug: Lobaplatin
* Drug: Cisplatin
* Drug: Oxaliplatin, Leucovorin, fluorouracil
* Drug: Lobaplatin, Raltitrexed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergone radical surgical resection. Aged 18-75. Patients voluntarily cooperated with the study and signed an informed consent form. Histopathologically diagnosed hepatocellular carcinoma. 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. No serious heart, lung, or renal dysfunction Exclusion Criteria: Unable to provide specimens for PDOX testing. Patients with recurrent liver cancer. Developing two or more types of tumors simultaneously. Patients with existing extrahepatic distant metastases. 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. Died within 1 month after surgery.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the test group<br>The test group received postoperative conventional treatment combined with precise transarterial chemoembolization based on PDOX results. Precise transarterial chemoembolization at 1-month intervals for 2 months after surgery. | Drug: Oxaliplatin<br>* 130 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.<br>Drug: Doxorubicin<br>* 20 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.<br>Drug: Lobaplatin<br>* 50 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.<br>Drug: Cisplatin<br>* 50 mg per square body surface area was used for monthly transhepatic arterial infusions.<br>Drug: Oxaliplatin, Leucovorin, fluorouracil<br>* 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<br>Drug: Lobaplatin, Raltitrexed<br>* Lobaplatin(50 mg per square body surface area) and Raltitrexed(3 mg per square body surface area) were used for monthly transhepatic arterial infusions.<br>|
| Active Comparator: the control group<br>The control group received postoperative conventional treatment combined with Empirical transarterial chemoembolization with Doxorubicin. Empirical transarterial chemoembolization at 1-month intervals for 2 months after surgery. | Drug: Doxorubicin<br>* 20 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The one-year DFS rate | The one-year DFS rate is defined as the percentage of participants who have not accrued disease at the time of 1 year. | From the start date of the Treatment until date of the time of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | From the beginning of therapy until the date of death from any cause(max 24 months) |