Clinical trial NCT05701436: Applicability of 3D-HDRA in Patients With Primary Liver Cancer: A Randomized Controlled Trial
Official title: Applicability of 3D Histoculture Drug Response Assay(3D-HDRA) in Patients With Primary Liver Cancer: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Liver, Cancer of, Primary Resectable
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The test group received postoperative conventional treatment combined with precise transarterial chemoembolization based on 3D-HDRA results, and the control group received postoperative conventional treatment combined with Empirical transarterial chemoembolization.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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 single tumor lesion) before performing radical surgery; patients with a confirmed diagnosis of primary liver cancer after postoperative pathological histological examination.
4. Patients with R0 resection confirmed by imaging and pathology (no residual lesions and complete 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 effective contraception for the duration of the study.

Exclusion Criteria:

1. Patients with recurrent liver cancer.
2. Patients with existing extrahepatic distant metastases (including local lymph node metastases or distant organ metastases: e.g., lung, brain, bone, etc.) at the time of diagnosis.
3. Treatment with other experimental drugs or other interventions after radical resection.
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 months after surgery.
7. Patients in whom death occurred within 30 days after surgery.

Primary outcomes:
measure: The one-year DFS rate
timeFrame: From the start date of the Treatment until date of the time of 1 year
Secondary outcomes:
measure: Adverse events
timeFrame: From the beginning of therapy until the date of death from any cause(max 24 months)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Study Principal Investigator Southern Medical University, China
name: Mingxin Pan, Prof
role: STUDY_DIRECTOR
References: