Applicability of 3D-HDRA in Patients With Primary Liver Cancer: A Randomized Controlled Trial
NCT ID: NCT05701436
Last Updated: 2023-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
144 participants
INTERVENTIONAL
2022-09-01
2026-03-01
Brief Summary
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Detailed Description
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The primary endpoint was the one-year disease-free survival(DFS) rate #Secondary endpoint was the adverse event.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Oxaliplatin
130 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.
Doxorubicin
20 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.
Lobaplatin
50 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.
Cisplatin
50 mg per square body surface area was used for monthly transhepatic arterial infusions.
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.
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.
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.
Oxaliplatin
130 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.
Doxorubicin
20 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.
Lobaplatin
50 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.
Cisplatin
50 mg per square body surface area was used for monthly transhepatic arterial infusions.
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.
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.
Interventions
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Oxaliplatin
130 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.
Doxorubicin
20 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.
Lobaplatin
50 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.
Cisplatin
50 mg per square body surface area was used for monthly transhepatic arterial infusions.
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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Zhujiang Hospital
OTHER
Responsible Party
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Principal Investigators
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Mingxin Pan, Prof
Role: STUDY_DIRECTOR
Study Principal Investigator Southern Medical University, China
Locations
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Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-KY-277-01
Identifier Type: -
Identifier Source: org_study_id
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