Back to resultsApplicability of PDOX in Patients With Primary Liver Cancer: A Randomized Controlled Trial
Primary Purpose
Hepatocellular Carcinoma Resectable
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Oxaliplatin
Doxorubicin
Lobaplatin
Cisplatin
Oxaliplatin, Leucovorin, fluorouracil
Lobaplatin, Raltitrexed
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma Resectable
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.
Sites / Locations
- Zhujiang Hospital of Southern Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
the test group
the control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05766605
Brief Title
Applicability of PDOX in Patients With Primary Liver Cancer: A Randomized Controlled Trial
Official Title
Applicability of Patient Derived Orthotopic Xenograft (PDOX) in Patients With Primary Liver Cancer: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
January 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhujiang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma Resectable
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
the test group
Arm Type
Experimental
Arm Description
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.
Arm Title
the control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
130 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
20 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.
Intervention Type
Drug
Intervention Name(s)
Lobaplatin
Intervention Description
50 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
50 mg per square body surface area was used for monthly transhepatic arterial infusions.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin, Leucovorin, fluorouracil
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Lobaplatin, Raltitrexed
Intervention Description
Lobaplatin(50 mg per square body surface area) and Raltitrexed(3 mg per square body surface area) were used for monthly transhepatic arterial infusions.
Primary Outcome Measure Information:
Title
The one-year DFS rate
Description
The one-year DFS rate is defined as the percentage of participants who have not accrued disease at the time of 1 year.
Time Frame
From the start date of the Treatment until date of the time of 1 year
Secondary Outcome Measure Information:
Title
Adverse events
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame
From the beginning of therapy until the date of death from any cause(max 24 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mingxin Pan, Prof.
Phone
+8618928918216
Email
pmxwxy@sohu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mingxin Pan, Prof.
Organizational Affiliation
Study Principal Investigator Southern Medical University, China
Official's Role
Study Director
Facility Information:
Facility Name
Zhujiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510220
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingxin Pan, Prof.
Phone
+8618928918216
Email
pmxwxy@sohu.com
12. IPD Sharing Statement
Learn more about this trial
Applicability of PDOX in Patients With Primary Liver Cancer: A Randomized Controlled Trial
We'll reach out to this number within 24 hrs