Trial Title:
A Study of the Application of HAIC in Advanced HCC Previously Treated With ICIs and Antiangiogenic Agents
NCT ID:
NCT05718492
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Leucovorin
Oxaliplatin
Fluorouracil
Conditions: Keywords:
Hepatic arterial infusion chemotherapy
Hepatocellular Carcinoma
Immunocheckpoint inhibitor
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
digital subtraction angiography.
Description:
Each patient received an artery catheter procedure guided by digital subtraction
angiography.
Arm group label:
HAIC
Intervention type:
Drug
Intervention name:
FOLFOX (oxaliplatin , leucovorin , fluorouracil , and fluorouracil )
Description:
Hepatic artery infusion chemotherapy. The FOLFOX (oxaliplatin 130 mg/m2, leucovorin 200
mg/m2, fluorouracil 400 mg/m2, and fluorouracil 2,400 mg/m2) regimen was sequentially
infused through the catheter every cycle (3 weeks).
Arm group label:
HAIC
Summary:
Immune checkpoint inhibitors (ICIs) plus antiangiogenic agents can achieve better
efficacy than sorafenib in the treatment of hepatocellular carcinoma (HCC) within a
certain period of time, but more than half of the patients are still insensitive to the
treatment. There is no evidence-based basis for second-line treatment after the
progression of the disease.In view of the effectiveness of Hepatic arterial infusion
(HAIC) in the first-line treatment of HCC in the Chinese population, this study intends
to launch a prospective intervention study to explore the efficacy and safety of HAIC
treatment in patients with advanced HCC after the failure of ICIs and antiangiogenic
agents combination therapy, and to provide high-level evidence for optimizing the
second-line treatment of advanced HCC in the future.
Detailed description:
Each patient received an artery catheter procedure guided by digital subtraction
angiography. Then, the FOLFOX (oxaliplatin 130 mg/m^2, leucovorin 200 mg/m^2,
fluorouracil 400 mg/m^2, and fluorouracil 2,400 mg/m^2) regimen was sequentially infused
through the catheter every cycle (3 weeks).A maximum of 4-6 courses of continuous hepatic
artery infusion chemotherapy were received.If the patient has extrahepatic metastasis at
baseline, ICIs should be used as a systemic treatment according to the severity of the
disease. The drug type and treatment protocol of ICIs should be based on the most
advanced treatment progress in the world.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Cytohistological confirmation is required for diagnosis of HCC. Patients with advanced
(unresectable and/or metastatic, stage C based on Barcelona-Clinic Liver Cancer [BCLC]
staging classification) hepatocellular carcinoma.
At least one tumor lesion meeting measurable disease criteria as determined by RECIST
v1.1.
Current cirrhotic status of Child-Pugh class A-B, with no encephalopathy. Ascites
controlled by diuretics is permitted in this study.
Availability of a representative tumor tissue specimen (archival tumor tissue is allowed)
at pre-screening.
Eastern Cooperative Oncology Group Scale for Assessment of Patient Performance Status ≤
2.
Both men and women enrolled in this trial must use adequate barrier birth control
measures during the course of the trial and 4 weeks after the completion of trial.
Adequate bone marrow, liver and renal function as assessed by central lab by means of the
following laboratory requirements from samples within 7 days prior to procedure:
Hemoglobin > 100g/L Absolute neutrophil count >3.0 ×109/L Neutrophil count > 1.5 ×109/L
Platelet count ≥ 50.0 ×109/L Total bilirubin < 51 μmol/L Alanine transaminase (ALT) and
aminotransferase (AST) < 5 x upper limit of normal Albumin > 28 g/L Prothrombin time
(PT)-international normalized ratio (INR) < 2.3, or PT < 6 seconds above control Serum
creatinine < 110 μmol/L Willing and able to comply with scheduled visits, treatment plan
and laboratory tests.
Exclusion Criteria:
Local treatments for HCC have been performed within 4 weeks, including surgical resection
(including liver transplantation), local ablation, transcatheter arterial
chemoembolization (TACE or TAE), radiotherapy (including brachytherapy).
A history of liver decompensation, such as refractory ascites, gastrointestinal bleeding,
or hepatic encephalopathy; Uncontrolled complications, including but not limited to:
Persistent or activity (except the HBV and HCV) infection, symptoms of congestive heart
failure and uncontrolled diabetes, uncontrolled hypertension, unstable angina,
uncontrolled arrhythmias, active ILD, severe chronic GI disease accompanied by diarrhea,
or compliance with requirements may limit the research, resulted in significant increase
risk of AE or influence Subjects provided psychiatric/social problem status on their
ability to provide written informed consent. A history of active primary immunodeficiency
or human immunodeficiency virus; Active or previous records of autoimmune disease or
inflammatory diseases, including inflammatory bowel disease (e.g., colitis or Crohn's
disease], diverticulitis, except [diverticulosis], systemic lupus erythematosus (SLE),
sarcoidosis syndrome or Wegener syndrome (e.g., granulomatous vasculitis, gray's disease,
rheumatoid arthritis, the pituitary gland inflammation and uveitis]).
Known to produce allergic or hypersensitive reactions to any study drug or any excipient
thereof.
Significant clinical gastrointestinal bleeding or a potential risk of bleeding was
identified by the investigator during the 30 days prior to study entry.
Tumors of the central nervous system, including metastatic brain tumors. Pregnant women
or breast-feeding patients.
Complicated with other malignant tumors:
Malignant tumors that have been treated for therapeutic purposes, have no known active
disease for 5 years prior to the first administration of the study drug, and have a low
potential risk of recurrence.
Fully treated non-melanoma skin cancer or malignant freckle moles with no evidence of
disease.
Fully treated carcinoma in situ without evidence of disease.
Is currently using, or has used an immunosuppressive drug within 14 days prior to the
first dose of the investigational drug. This standard has the following exceptions:
intranasal, inhaled, topical or topical steroids. (e.g., intraarticular) Systemic
corticosteroid therapy not exceeding 10 mg/ day of prednisone or its physiological
equivalent as a prophylactic use of steroids for hypersensitivity. (e.g., CT scan
pretherapy medication) Steroids as a prophylactic for allergic reactions. A live
attenuated vaccine was administered within 30 days prior to the first administration of
the study drug. Note: If enrolled, patients shall not receive live attenuated vaccine
within 30 days of receiving study drug therapy and after the last administration of study
drug.
Uncontrolled hypertension: systolic pressure ≥ 160 mmHg or diastolic pressure ≥ 100 mmHg
despite anti-hypertension medications ≤ 28 days before randomization or first dose of
drug.
Pregnant or lactating women, or fertile men or women who do not want to use
high-efficiency contraceptives, 6 months after the last dosing of study treatment, from
screening to study treatment. Based on the patient's preferred and customary lifestyle,
abstinence during treatment and washout is an acceptable contraceptive method.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Minimally Invasive and Interventional Radiology, Liver Cancer Study and Service Group, Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
500060
Country:
China
Status:
Recruiting
Contact:
Last name:
Ming Zhao, M.D. & Ph.D.
Phone:
+86-20-87343272
Email:
zhaoming@sysucc.org.cn
Start date:
October 18, 2022
Completion date:
October 18, 2026
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05718492
