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

NCT05701436 | Recruiting Phase 3

• 1 other identifier: 2022-KY-277-01
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver, Cancer of, Primary 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 3D-HDRA results. Precise transarterial chemoembolization at 1-month intervals for 4 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. Empirical transarterial chemoembolization at 1-month intervals for 4 months after surgery.

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

Interventions

Oxaliplatin DRUG

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

the control group; 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 control group; the test group

Cisplatin DRUG

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

the control group; 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 control group; 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 control group; 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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 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

18928918216; 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 3D-HDRA results, and the control group received postoperative conventional treatment combined with Empirical transarterial chemoembolization.

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: January 27, 2023
• Study Start: September 1, 2022
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 2, 2023

Record last verified: 2023-01

Locations

CN (1)