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Trial Title:
Applicability of PDOX in Patients With Primary Liver Cancer: A Randomized Controlled Trial
NCT ID:
NCT05766605
Condition:
Hepatocellular Carcinoma Resectable
Conditions: Official terms:
Liver Neoplasms
Leucovorin
Doxorubicin
Oxaliplatin
Fluorouracil
Raltitrexed
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
130 mg per square body surface area for a total of four transcatheter hepatic artery
infusions per month.
Arm group label:
the test group
Intervention type:
Drug
Intervention name:
Doxorubicin
Description:
20 mg per square body surface area for a total of four transcatheter hepatic artery
infusions per month.
Arm group label:
the control group
Arm group label:
the test group
Intervention type:
Drug
Intervention name:
Lobaplatin
Description:
50 mg per square body surface area for a total of four transcatheter hepatic artery
infusions per month.
Arm group label:
the test group
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
50 mg per square body surface area was used for monthly transhepatic arterial infusions.
Arm group label:
the test group
Intervention type:
Drug
Intervention name:
Oxaliplatin, Leucovorin, fluorouracil
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
Arm group label:
the test group
Intervention type:
Drug
Intervention name:
Lobaplatin, Raltitrexed
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.
Arm group label:
the test group
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhujiang Hospital of Southern Medical University
Address:
City:
Guangzhou
Zip:
510220
Country:
China
Status:
Recruiting
Contact:
Last name:
Mingxin Pan, Prof.
Phone:
+8618928918216
Email:
pmxwxy@sohu.com
Start date:
January 1, 2023
Completion date:
January 30, 2026
Lead sponsor:
Agency:
Zhujiang Hospital
Agency class:
Other
Source:
Zhujiang Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05766605
