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

March 1, 2023 updated by: Zhujiang Hospital

Applicability of Patient Derived Orthotopic Xenograft (PDOX) in Patients With Primary Liver Cancer: A Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • 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

  • Name: Mingxin Pan, Prof.
  • Phone Number: +8618928918216
  • Email: pmxwxy@sohu.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510220
        • 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

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. 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 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
Intervention / Treatment
Experimental: the test group
The test group received postoperative conventional treatment combined with precise transarterial chemoembolization based on PDOX results. Precise transarterial chemoembolization at 1-month intervals for 2 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: 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.
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
Active Comparator: the control group
The control group received postoperative conventional treatment combined with Empirical transarterial chemoembolization with Doxorubicin. Empirical transarterial chemoembolization at 1-month intervals for 2 months after surgery.
Drug: Doxorubicin
20 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.

What is the study measuring?

Primary Outcome Measures

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

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

Zhujiang Hospital

Investigators

  • 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)

January 1, 2023

Primary Completion (Anticipated)

January 1, 2026

Study Completion (Anticipated)

January 30, 2026

Study Registration Dates

First Submitted

March 1, 2023

First Submitted That Met QC Criteria

March 1, 2023

First Posted (Actual)

March 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-KY-298-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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