Clinical trial NCT05766605: 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
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hepatocellular Carcinoma Resectable
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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.

Primary outcomes:
measure: The one-year DFS rate
timeFrame: From the start date of the Treatment until date of the time of 1 year
Secondary outcomes:
measure: Adverse events
timeFrame: From the beginning of therapy until the date of death from any cause(max 24 months)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Study Principal Investigator Southern Medical University, China
name: Mingxin Pan, Prof.
role: STUDY_DIRECTOR
References: