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

NCT05766605 | Unknown Phase 3

• 1 other identifier: 2022-KY-298-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma Resectable

Outcome Measures

Primary Outcomes (1)

• 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.

  From the start date of the Treatment until date of the time of 1 year

Secondary Outcomes (1)

• Adverse events

  From the beginning of therapy until the date of death from any cause(max 24 months)

Study Arms (2)

the test group

EXPERIMENTAL

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; Drug: Doxorubicin; Drug: Lobaplatin; Drug: Cisplatin; Drug: Oxaliplatin, Leucovorin, fluorouracil; Drug: Lobaplatin, Raltitrexed

the control group

ACTIVE COMPARATOR

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

Interventions

Oxaliplatin DRUG

130 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.

the test group

Doxorubicin DRUG

20 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.

the control group; the test group

Lobaplatin DRUG

50 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.

the test group

Cisplatin DRUG

50 mg per square body surface area was used for monthly transhepatic arterial infusions.

the test group

Oxaliplatin, Leucovorin, fluorouracil DRUG

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

the test group

Lobaplatin, Raltitrexed DRUG

Lobaplatin(50 mg per square body surface area) and Raltitrexed(3 mg per square body surface area) were used for monthly transhepatic arterial infusions.

the test group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergone radical surgical resection.
• Aged 18-75.
• Patients voluntarily cooperated with the study and signed an informed consent form.
• Histopathologically diagnosed hepatocellular carcinoma.
• 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.
• No serious heart, lung, or renal dysfunction

You may not qualify if:

• Unable to provide specimens for PDOX testing.
• Patients with recurrent liver cancer.
• Developing two or more types of tumors simultaneously.
• Patients with existing extrahepatic distant metastases.
• 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.
• Died within 1 month after surgery.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510220, China

RECRUITING

MeSH Terms

Interventions

Oxaliplatin; Doxorubicin; lobaplatin; Cisplatin; Leucovorin; Fluorouracil; raltitrexed

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Mingxin Pan, Prof.

  Study Principal Investigator Southern Medical University, China

  STUDY DIRECTOR

Central Study Contacts

Mingxin Pan, Prof.

CONTACT

+8618928918216; pmxwxy@sohu.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The test group received postoperative conventional treatment combined with precise transarterial chemoembolization based on PDOX results, and the control group received postoperative conventional treatment combined with empirical transarterial chemoembolization with Doxorubicin.

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 13, 2023
• Study Start: January 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 30, 2026
• Last Updated: March 13, 2023

Record last verified: 2023-02

Locations

CN (1)