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

March 1, 2023 updated by: Zhujiang Hospital

Applicability of 3D Histoculture Drug Response Assay(3D-HDRA) in Patients With Primary Liver Cancer: A Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Mingxin Pan, Prof
  • Phone Number: 18928918216 18928918216
  • Email: pmxwxy@sohu.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • ZhuJiang Hospital of Southern Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: the test group
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.
Drug: Oxaliplatin
130 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.
Drug: Doxorubicin
20 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.
Drug: Lobaplatin
50 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.
Drug: Cisplatin
50 mg per square body surface area was used for monthly transhepatic arterial infusions.
Drug: Oxaliplatin, Leucovorin, fluorouracil
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.
Drug: Lobaplatin, Raltitrexed
Lobaplatin(50 mg per square body surface area) and Raltitrexed(3 mg per square body surface area) were used for monthly transhepatic arterial infusions.
Active Comparator: the control group
The control group received postoperative conventional treatment combined with Empirical transarterial chemoembolization. Empirical transarterial chemoembolization at 1-month intervals for 4 months after surgery.
Drug: Oxaliplatin
130 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.
Drug: Doxorubicin
20 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.
Drug: Lobaplatin
50 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.
Drug: Cisplatin
50 mg per square body surface area was used for monthly transhepatic arterial infusions.
Drug: Oxaliplatin, Leucovorin, fluorouracil
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.
Drug: Lobaplatin, Raltitrexed
Lobaplatin(50 mg per square body surface area) and Raltitrexed(3 mg per square body surface area) were used for monthly transhepatic arterial infusions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The one-year DFS rate
Time Frame: From the start date of the Treatment until date of the time of 1 year
The one-year DFS rate is defined as the percentage of participants who have not accrued disease at the time of 1 year
From the start date of the Treatment until date of the time of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: From the beginning of therapy until the date of death from any cause(max 24 months)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
From the beginning of therapy until the date of death from any cause(max 24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhujiang Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mingxin Pan, Prof, Study Principal Investigator Southern Medical University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-KY-277-01

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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