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

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: Recruiting
• Conditions: Liver, Cancer of, Primary Resectable
• Intervention / Treatment: Drug: Oxaliplatin; Drug: Doxorubicin; Drug: Lobaplatin; Drug: Cisplatin; Drug: Oxaliplatin, Leucovorin, fluorouracil; Drug: Lobaplatin, Raltitrexed

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: Interventional
• Enrollment (Anticipated): 144
• Phase: Phase 3

Contacts and Locations

• Study Contact: 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: Mingxin Pan, Prof; Phone Number: 18928918216; Email: pmxwxy@sohu.com

Participation Criteria

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. 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

How is the study designed?

Design Details

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

Number of Arms

2

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 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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	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

• Sponsor: Zhujiang Hospital
• Investigators: Study Director: Mingxin Pan, Prof, Study Principal Investigator Southern Medical University, China

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Anticipated): January 1, 2026
• Study Completion (Anticipated): March 1, 2026

Study Registration Dates

• First Submitted: January 18, 2023
• First Submitted That Met QC Criteria: January 18, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protective Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Micronutrients; Antibiotics, Antineoplastic; Vitamins; Antidotes; Vitamin B Complex; Folic Acid Antagonists; Fluorouracil; Oxaliplatin; Leucovorin; Doxorubicin; Raltitrexed
• Other Study ID 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