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

Phase 3

Recruiting

• Conditions: Hepatocellular Carcinoma Resectable
• Interventions: Drug: Oxaliplatin; Drug: Doxorubicin; Drug: Lobaplatin; Drug: Cisplatin; Drug: Oxaliplatin, Leucovorin, fluorouracil; Drug: Lobaplatin, Raltitrexed

• Registration Number: NCT05766605
• Lead Sponsor: Zhujiang Hospital

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.

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2023-02
• Study First Submitted: 2023-03-01
• Study First Submitted QC: 2023-03-01
• Last Update Submitted: 2023-03-01
• Study First Posted: 2023-03-13
• Last Update Posted: 2023-03-13
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the test group	Oxaliplatin, Leucovorin, fluorouracil	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 test group	Lobaplatin, Raltitrexed	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 test group	Oxaliplatin	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 test group	Doxorubicin	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 test group	Cisplatin	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 test group	Lobaplatin	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	Doxorubicin	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.

Primary Outcome Measures

Name	Time	Method
The one-year DFS rate	From the start date of the Treatment until date of the time of 1 year	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

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

Trial Locations

Locations (1)

Zhujiang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China