Applicability of 3D-HDRA in Patients With Primary Liver Cancer: A Randomized Controlled Trial

Last updated: March 1, 2023
Sponsor: Zhujiang Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Digestive System Neoplasms

Liver Cancer

Primary Biliary Cholangitis

Treatment

N/A

Clinical Study ID

NCT05701436
2022-KY-277-01
  • Ages 18-75
  • All Genders

Study Summary

This Randomized Controlled Trial was to clarity the clinical feasibility of 3D-HDRA results in guiding the drug use of interventional chemotherapy after primary liver cancer surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients voluntarily cooperated with the study and signed an informed consent form.
  2. Any gender, age 18 or older, 75 or younger.
  3. Patients who need to confirm the maximum tumor load (the maximum diameter of a singletumor lesion) before performing radical surgery; patients with a confirmed diagnosisof primary liver cancer after postoperative pathological histological examination.
  4. Patients with R0 resection confirmed by imaging and pathology (no residual lesions andcomplete tumor resection after radical surgery).
  5. Child-Pugh score of 5-7 (A or B), patients with a score of 7 must be free of ascites.
  6. ECOG physical fitness status score of 0-1.
  7. Women of childbearing age with a negative pregnancy test and willing to use effectivecontraception for the duration of the study.

Exclusion

Exclusion Criteria:

  1. Patients with recurrent liver cancer.
  2. Patients with existing extrahepatic distant metastases (including local lymph nodemetastases or distant organ metastases: e.g., lung, brain, bone, etc.) at the time ofdiagnosis.
  3. Treatment with other experimental drugs or other interventions after radicalresection.
  4. Patients with other malignant tumors that have not been cured within 5 years.
  5. Patients with non-radical resections (R1 and R2 resections).
  6. Patients with residual or recurrent lesions detected on imaging within 1-2 monthsafter surgery.
  7. Patients in whom death occurred within 30 days after surgery.

Study Design

Total Participants: 144
Study Start date:
September 01, 2022
Estimated Completion Date:
March 01, 2026

Study Description

Data of Patients who received 3D-HDRA 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.

Connect with a study center

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong
    China

    Active - Recruiting

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