Comparing Concurrent Versus Sequential Hepatic Arterial Infusion Chemotherapy Combined With Targeted and Immunotherapy for Potentially Resectable Intermediate and Advanced Liver Cancer
Led by Sun Yat-sen University · Updated on 2024-08-27
540
Participants Needed
1
Research Sites
156 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating two different ways to combine hepatic arterial infusion chemotherapy HAIC with targeted drugs and immunotherapy in patients who have potentially removable intermediate to advanced hepatocellular carcinoma HCC, a type of liver cancer. The study aims to find out whether giving all three treatments at the same time or giving HAIC first followed by the other treatments based on response leads to better surgical outcomes, survival, and safety.
Participants are randomly divided into two groups. One group receives two cycles of HAIC combined with targeted drug lenvatinib and PD-1 antibody immunotherapy simultaneously, followed by tumor response evaluation. Depending on the response, they may have surgery, continue treatment, or switch to other therapies. The second group receives two cycles of HAIC alone first, then tumor response is evaluated those without complete response receive two additional cycles of HAIC combined with the targeted drug and immunotherapy. After four cycles, patients are re-evaluated for surgery or further treatment.
During the study, participants undergo tumor response assessments after two and four treatment cycles, with ongoing safety monitoring for about three years. Researchers will measure overall survival from the time of randomization until death, progression-free survival, response rates, and safety profiles. Participants will be closely followed to track treatment effects, surgical outcomes, and any side effects over this period.
CONDITIONS
Brief Title
Concurrently vs Sequentially Combined HAIC With Targeted and Immunotherapy in Potentially Resectable HCC
Research Team
S
Shao Hua Li, Ph.D, M,D
R
Rong Ping Guo, M,D
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The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Collaborating Sponsor
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
Age 18 to 75 years
ECOG performance status score of 0 to 1
Clinical or pathological diagnosis of hepatocellular carcinoma at CNLC stage IIa to IIIa
No previous treatment for hepatocellular carcinoma
Tumors not initially resectable but potentially removable after conversion therapy
Laboratory tests meet specified blood counts and liver/kidney function levels or can be improved with short-term treatment
Fully informed and provided signed consent
You will not qualify if you...
Severe heart, brain, lung, kidney, or other vital organ dysfunction or serious infections making treatment intolerable
History of other cancers
Known allergy to study drugs
History of organ transplantation
Previous targeted treatment for hepatocellular carcinoma
HIV infection
Drug abuse
Recent gastrointestinal bleeding or cardiovascular events within 30 days
Pregnant or breastfeeding women or women not using contraception if of childbearing age
Psychiatric disorders affecting consent or treatment acceptance
Other factors affecting enrollment or assessment results
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 16 weeks (4 cycles of 4 weeks each)
Participants receive up to four cycles of hepatic arterial infusion chemotherapy combined with targeted drug (lenvatinib) and immunotherapy (PD-1 antibody). In the concurrent group, all treatments are combined from the first cycle. In the sequential group, targeted and immunotherapy start from the third cycle for those who do not achieve complete response after two cycles of chemotherapy alone. Tumor response is evaluated after two and four cycles to determine further treatment or surgical resection.
Weekly visits during each 4-week cycle for treatment and assessment
Post-treatment Evaluation and Follow-up
Duration - Variable duration depending on surgical decisions or follow-up plans
Participants who achieve complete response after treatment may undergo surgical resection or enter follow-up observation. Others are evaluated for surgical options or subsequent treatments.
Visits depending on surgical and follow-up schedules
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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Published Research Related To This Trial
Postoperative Adjuvant Transarterial Infusion Chemotherapy with FOLFOX Could Improve Outcomes of Hepatocellular Carcinoma Patients with Microvascular Invasion: A Preliminary Report of a Phase III, Randomized Controlled Clinical Trial.
Sorafenib Plus Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin vs Sorafenib Alone for Hepatocellular Carcinoma With Portal Vein Invasion: A Randomized Clinical Trial.
Postoperative Adjuvant Hepatic Arterial Infusion Chemotherapy With FOLFOX in Hepatocellular Carcinoma With Microvascular Invasion: A Multicenter, Phase III, Randomized Study.
Hepatic artery infusion chemotherapy using mFOLFOX versus transarterial chemoembolization for massive unresectable hepatocellular carcinoma: a prospective non-randomized study.
Preoperative transarterial chemoembolization and resection for hepatocellular carcinoma: a nationwide Taiwan database analysis of long-term outcome predictors.