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

Hepatocellular Carcinoma Resectable Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05766605
• Other study ID #: 2022-KY-298-01
• Status: Recruiting
• Phase: Phase 3
• Start date: January 1, 2023
• Est. completion date: January 30, 2026

Study information

• Verified date: February 2023
• Source: Zhujiang Hospital
• Contact: Mingxin Pan, Prof.
• Phone: +8618928918216
• Email: pmxwxy[@]sohu.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 30, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatocellular Carcinoma Resectable
• Liver Neoplasms

Intervention

Drug:
• Oxaliplatin
130 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.
• Doxorubicin
20 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.
• Lobaplatin
50 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.
• Cisplatin
50 mg per square body surface area was used for monthly transhepatic arterial infusions.
• Oxaliplatin, Leucovorin, fluorouracil
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, Raltitrexed
Lobaplatin(50 mg per square body surface area) and Raltitrexed(3 mg per square body surface area) were used for monthly transhepatic arterial infusions.

Locations

Country	Name	City	State
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)