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Trial Title:
Prospective Real-World Study of HAIC With Raltitrexed or 5-Fluorouracil for the Treatment of Hepatocellular Carcinoma
NCT ID:
NCT06519578
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
hepatic artery infusion chemotherapy
Description:
HAIC is a regional therapy that takes advantage of the fact that hepatic tumors,
particularly hepatocellular carcinoma, predominantly receive their blood supply from the
hepatic artery. The procedure typically involves the insertion of a catheter into the
hepatic artery, often through a percutaneous approach or during a surgical procedure.
FOLFOX (5-fluorouracil, leucovorin combined with oxaliplatin) or RALOX (raltitrexed
combined with oxaliplatin) Q3W.
Arm group label:
FOLFOX-HAIC Cohort
Arm group label:
RALOX-HAIC Cohort
Other name:
HAIC
Summary:
This study is a prospective cohort study aimed at comparing the efficacy and safety of
RALOX-HAIC and FOLFOX-HAIC in the treatment of hepatocellular carcinoma. It is planned to
enroll 1115 patients with BCLC Stage B or C hepatocellular carcinoma, who will receive
FOLFOX-HAIC or RALOX-HAIC treatment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Presence of clinically significant pleural effusion, ascites, or pericardial
effusion that requires repeated treatment (puncture or drainage, etc.);
- History of immunodeficiency, including positive HIV test, or known history of
allogeneic organ transplantation or allogeneic hematopoietic stem cell
transplantation;
- Severe cardiovascular and cerebrovascular diseases, including but not limited to,
myocardial infarction, severe/unstable angina, congestive heart failure (NYHA heart
function classification ≥2), clinically significant supraventricular or ventricular
arrhythmias requiring drug intervention, aortic aneurysm requiring surgical repair,
any arterial thrombosis/embolism events, grade 3 or higher (Common Terminology
Criteria for Adverse Events [CTCAE] 5.0) venous thrombosis/embolism events,
transient cerebral ischemic attacks, cerebrovascular accidents;
- Abdominal or tracheoesophageal fistula, gastrointestinal (GI) perforation or
intra-abdominal abscess within 6 months before the first study drug administration;
- Severe infection (CTCAE 5.0 > grade 2) occurred within 28 days before the first drug
administration, such as severe pneumonia requiring hospitalization, bacteremia,
infectious complications, etc.; active infection requiring intravenous
anti-infection treatment within 2 weeks before the first drug administration or
fever of unknown cause >38.5℃ (subject to the investigator's judgment, fever caused
by the tumor can be enrolled);
- History of another primary malignant tumor, but malignant tumors that have been
treated with curative treatment before the first intervention of the study and have
no known active disease (more than 5 years) and a low potential for recurrence (such
as skin basal cell carcinoma and skin squamous cell carcinoma treated with potential
curative treatment) are excluded;
- History of gastrointestinal bleeding within 6 months before enrollment, or
conditions judged by the investigator to have a risk of gastrointestinal bleeding
(such as severe esophageal-gastric varices);
- Other severe physical or mental diseases or laboratory test abnormalities that may
increase the risk of participating in the study, affect treatment compliance, or
interfere with the study results, and patients judged by the investigator as
unsuitable to participate in this study.
Exclusion Criteria:
- The subject requests to terminate study treatment;
- Disease progression occurs, and the investigator judges that continuing study
treatment has no clinical benefit;
- Any clinical adverse event, laboratory test abnormality, or other medical condition
occurs, making it likely that the subject will no longer benefit from continued
medication；
- Pregnancy occurs in a female subject;
- There is a significant deviation from the protocol, and the investigator determines
that study treatment should be terminated;
- The subject dies or is lost to follow-up;
- The study is terminated;
- Other situations determined by the investigator that require termination of study
treatment.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Address:
City:
Shanghai
Zip:
200127
Country:
China
Status:
Recruiting
Contact:
Last name:
Qiang Xia, MD, PhD
Phone:
021-68383651
Phone ext:
86
Email:
xiaqiang@medmail.com.cn
Facility:
Name:
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Address:
City:
Shanghai
Zip:
200127
Country:
China
Status:
Recruiting
Contact:
Last name:
Hao Feng, MD, PhD
Phone:
021-68383651
Phone ext:
86
Email:
surgeonfeng@live.com
Start date:
August 1, 2024
Completion date:
July 31, 2027
Lead sponsor:
Agency:
RenJi Hospital
Agency class:
Other
Source:
RenJi Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06519578
