Actively Recruiting
Concurrently vs Sequentially Combined HAIC With Targeted and Immunotherapy in Potentially Resectable HCC
Led by Sun Yat-sen University · Updated on 2024-08-27
540
Participants Needed
1
Research Sites
347 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
T
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to compare HAIC concurrently with sequentially combined with targeted and immunotherapies in terms of efficacy and safety in patients with potentially resectable intermediate and advanced HCC (CNLC stage IIa\~IIIa). The main questions it aims to answer are: * Does a "strong combination" regimen of three simultaneous treatments (HAIC, targeted agents and immunotherapy) definitely result in a higher surgical conversion rate and better survival benefit? * Can the combination of targeted and immunotherapies based on patients' response to HAIC therapy avoid over-treatment of some patients without affecting the surgical conversion rate and overall survival? Participants will be randomly assigned to receive either HAIC concurrently or sequentially combined with targeted and immunotherapies. Researchers will compare concurrent treatment group with sequential treatment group to see if there are different in terms of the conversion resection rate, long-term survival, and safety.
CONDITIONS
Official Title
Concurrently vs Sequentially Combined HAIC With Targeted and Immunotherapy in Potentially Resectable HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- ECOG performance status score of 0 or 1
- Clinical or pathological diagnosis of hepatocellular carcinoma at CNLC stage IIa to IIIa
- No previous treatment for hepatocellular carcinoma
- Not initially eligible for surgery but potentially resectable after conversion therapy, including multiple tumors in one liver lobe or portal vein cancer thrombus not involving the main trunk
- Laboratory values within specified ranges or correctable with short-term treatment: neutrophils ≥ 2.0×10⁹/L, hemoglobin ≥ 100 g/L, platelets ≥ 75×10⁹/L, albumin ≥ 35 g/L, total bilirubin < 2 times upper limit normal, ALT and AST < 3 times upper limit normal, creatinine < 1.5 times upper limit normal, normal or slightly prolonged prothrombin time, INR ≤ 2.2
- Signed informed consent
You will not qualify if you...
- Severe heart, brain, lung, kidney, or other vital organ dysfunction with severe infection or serious disease (CTCAE grade > 2)
- History of other cancers
- Known allergy to study drugs
- Hypersensitivity to components of targeted or immunologic drugs used
- History of organ transplantation
- Previous treatment targeting hepatocellular carcinoma including interferon
- Co-infection with HIV
- History of drug abuse
- Gastrointestinal bleeding or cardiovascular events within past 30 days
- Pregnant, breastfeeding, or unwilling to use contraception if of childbearing potential
- Psychiatric disorders affecting consent or treatment acceptance
- Other factors affecting enrollment or assessment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
SUN Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
S
Shao Hua Li, Ph.D, M,D
CONTACT
R
Rong Ping Guo, M,D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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