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

Primary Purpose

Liver, Cancer of, Primary Resectable

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Oxaliplatin
Doxorubicin
Lobaplatin
Cisplatin
Oxaliplatin, Leucovorin, fluorouracil
Lobaplatin, Raltitrexed
Sponsored by
Zhujiang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver, Cancer of, Primary Resectable

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients voluntarily cooperated with the study and signed an informed consent form. Any gender, age 18 or older, 75 or younger. 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. Patients with R0 resection confirmed by imaging and pathology (no residual lesions and complete tumor resection after radical surgery). Child-Pugh score of 5-7 (A or B), patients with a score of 7 must be free of ascites. ECOG physical fitness status score of 0-1. Women of childbearing age with a negative pregnancy test and willing to use effective contraception for the duration of the study. Exclusion Criteria: Patients with recurrent liver cancer. 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. Treatment with other experimental drugs or other interventions after radical resection. Patients with other malignant tumors that have not been cured within 5 years. Patients with non-radical resections (R1 and R2 resections). Patients with residual or recurrent lesions detected on imaging within 1-2 months after surgery. Patients in whom death occurred within 30 days after surgery.

Sites / Locations

  • Zhujiang Hospital of Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

the test group

the control group

Arm Description

The test group received postoperative conventional treatment combined with precise transarterial chemoembolization based on 3D-HDRA results. Precise transarterial chemoembolization at 1-month intervals for 4 months after surgery.

The control group received postoperative conventional treatment combined with Empirical transarterial chemoembolization. Empirical transarterial chemoembolization at 1-month intervals for 4 months after surgery.

Outcomes

Primary Outcome Measures

The one-year DFS rate
The one-year DFS rate is defined as the percentage of participants who have not accrued disease at the time of 1 year

Secondary Outcome Measures

Adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Full Information

First Posted
January 18, 2023
Last Updated
March 1, 2023
Sponsor
Zhujiang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05701436
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhujiang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver, Cancer of, Primary Resectable

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the test group
Arm Type
Experimental
Arm Description
The test group received postoperative conventional treatment combined with precise transarterial chemoembolization based on 3D-HDRA results. Precise transarterial chemoembolization at 1-month intervals for 4 months after surgery.
Arm Title
the control group
Arm Type
Active Comparator
Arm Description
The control group received postoperative conventional treatment combined with Empirical transarterial chemoembolization. Empirical transarterial chemoembolization at 1-month intervals for 4 months after surgery.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
130 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
20 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.
Intervention Type
Drug
Intervention Name(s)
Lobaplatin
Intervention Description
50 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
50 mg per square body surface area was used for monthly transhepatic arterial infusions.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin, Leucovorin, fluorouracil
Intervention Description
Oxaliplatin(130 mg per square body surface area), Leucovorin(400 mg per square body surface area), and fluorouracil(2800 mg per square body surface area) were used for monthly transhepatic arterial infusions.
Intervention Type
Drug
Intervention Name(s)
Lobaplatin, Raltitrexed
Intervention Description
Lobaplatin(50 mg per square body surface area) and Raltitrexed(3 mg per square body surface area) were used for monthly transhepatic arterial infusions.
Primary Outcome Measure Information:
Title
The one-year DFS rate
Description
The one-year DFS rate is defined as the percentage of participants who have not accrued disease at the time of 1 year
Time Frame
From the start date of the Treatment until date of the time of 1 year
Secondary Outcome Measure Information:
Title
Adverse events
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame
From the beginning of therapy until the date of death from any cause(max 24 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients voluntarily cooperated with the study and signed an informed consent form. Any gender, age 18 or older, 75 or younger. 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. Patients with R0 resection confirmed by imaging and pathology (no residual lesions and complete tumor resection after radical surgery). Child-Pugh score of 5-7 (A or B), patients with a score of 7 must be free of ascites. ECOG physical fitness status score of 0-1. Women of childbearing age with a negative pregnancy test and willing to use effective contraception for the duration of the study. Exclusion Criteria: Patients with recurrent liver cancer. 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. Treatment with other experimental drugs or other interventions after radical resection. Patients with other malignant tumors that have not been cured within 5 years. Patients with non-radical resections (R1 and R2 resections). Patients with residual or recurrent lesions detected on imaging within 1-2 months after surgery. Patients in whom death occurred within 30 days after surgery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mingxin Pan, Prof
Phone
18928918216
Ext
18928918216
Email
pmxwxy@sohu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mingxin Pan, Prof
Organizational Affiliation
Study Principal Investigator Southern Medical University, China
Official's Role
Study Director
Facility Information:
Facility Name
Zhujiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingxin Pan, Prof
Phone
18928918216
Email
pmxwxy@sohu.com

12. IPD Sharing Statement

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

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