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

Zhujiang Hospital

Status and phase: Enrolling; Phase 3

Conditions: Hepatocellular Carcinoma Resectable

Treatments: Drug: Lobaplatin; Drug: Cisplatin; Drug: Doxorubicin; Drug: Lobaplatin, Raltitrexed; Drug: Oxaliplatin, Leucovorin, fluorouracil; Drug: Oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT05766605

2022-KY-298-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

the test group

Experimental group

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.

Treatment:

Drug: Lobaplatin, Raltitrexed

Drug: Oxaliplatin, Leucovorin, fluorouracil

Drug: Oxaliplatin

Drug: Doxorubicin

Drug: Lobaplatin

Drug: Cisplatin

the control group

Active Comparator group

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.

Treatment:

Drug: Doxorubicin