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

Sponsor

Zhujiang Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05701436

Collaborator

(none)

144

Enrollment

Location

Arms

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver, Cancer of, Primary Resectable	Drug: Oxaliplatin Drug: Doxorubicin Drug: Lobaplatin Drug: Cisplatin Drug: Oxaliplatin, Leucovorin, fluorouracil Drug: Lobaplatin, Raltitrexed	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Mar 1, 2026

Arms and Interventions

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.

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

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.

Outcome Measures

Primary Outcome Measures

The one-year DFS rate [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

Secondary Outcome Measures

Adverse events [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.