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

Z

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)

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

Trial contacts and locations

1

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Central trial contact

Mingxin Pan, Prof.

Data sourced from clinicaltrials.gov

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