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

Zhujiang Hospital

Status and phase: Enrolling; Phase 3

Conditions: Liver, Cancer of, Primary Resectable

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05701436

2022-KY-277-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

the test group

Experimental group

Description:

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.

Treatment:

Drug: Doxorubicin

Drug: Oxaliplatin, Leucovorin, fluorouracil

Drug: Lobaplatin

Drug: Oxaliplatin

Drug: Cisplatin

Drug: Lobaplatin, Raltitrexed

the control group

Active Comparator group

Description:

The control group received postoperative conventional treatment combined with Empirical transarterial chemoembolization. Empirical transarterial chemoembolization at 1-month intervals for 4 months after surgery.

Treatment:

Drug: Doxorubicin

Drug: Oxaliplatin, Leucovorin, fluorouracil

Drug: Lobaplatin

Drug: Oxaliplatin

Drug: Cisplatin

Drug: Lobaplatin, Raltitrexed