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

Recruiting
18 - 75 years of age
Both
Phase 3

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Overview

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.

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.

Study details

Hepatocellular Carcinoma Resectable

NCT05766605

Zhujiang Hospital

25 January 2024

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