Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
Location status: Recruiting
NCT Number: NCT06172205
This is a multi-center randomized phase III clinical study of first-line intravenous FOLFOX plus Camrelizumab and apatinib versus HAIC-FOLFOX plus Camrelizumab and apatinib for BCLC C stage hepatocellular carcinoma.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 3
Guangzhou, Guangdong, 510000, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Leucovorin 200mg/m2 administered IV on Days 1 of a 21 day cycle Oxaliplatin 85 mg/m2 IV on Days 1 of a 21 day cycle Fluorouracil 5-FU continuous infusion: 400mg/m2 on D1 and then 2400mg/m2 for 46h of each 21 day cycle.
Camrelizumab 200mg infusion on D1 for every 21 days Apatinib 250mg,po,qd for every 21 days
2-h infusion of oxaliplatin at 85 mg/m2 ,a 2-3-h administration of leucovorin at 200 mg/m2 , Fluorouracil 5-FU continuous infusion: 400mg/m2 on D1 and then 2400mg/m2 for 46h. Camrelizumab (200 mg intravenously, commencing in 7 days after the first HAIC cycle and repeated every 21 days) and apatinib (250 mg daily, taken orally, beginning in 7 days after the initial HAIC cycle). Camrelizumab 200mg infusion on D1 for every 21 days Apatinib 250mg,po,qd for every 21 days.
Time frame: up to approximately 3 years
The incidence of disease progression within the first 6 months of the patient's treatment
Time frame: up to approximately 3 years
ICG-R15 is a clinical parameter that assesses the volume of remaining functional hepatocytes, which reflects the functional reserve status of the liver. It is the most commonly used indicator for measuring the severity of liver damage.
Time frame: up to approximately 3 years
objective response rate based on mRECIST
Time frame: up to approximately 3 years
objective response rate based on RECISTv1.1
Time frame: up to approximately 3 years
Proportion of patients who achieved complete response (CR) or partial response (PR) at the end of treatment, based on mRECIST criteria. Patients were evaluated once every 3 cycles during the 1st to 6th treatment cycle and once every 3 months during the sequential treatment phase.
Time frame: up to approximately 3 years
The percentage of patients whose tumors shrink or stabilize for a certain period of time, including complete response (CR), partial response (PR), and stable (SD) cases. Patients were evaluated once every 3 cycles during the 1st to 6th treatment cycle and once every 3 months during the sequential treatment phase.
Time frame: 1 year
The proportion of patients who did not develop tumor progression from enrollment to 1 year of follow-up.
Time frame: 2 year
Proportion of patients surviving from the start of enrollment to the full 2 years of follow-up.
Time frame: up to approximately 5 years
The time between the start of treatment and the patient's death
Time frame: up to approximately 3 years
The classification of adverse events during treatment was based on NCI-CTCAE v5.0 criteria.
Time frame: up to approximately 3 years
rate of unresectable converted into resectable
Time frame: up to approximately 3 years
The time from the start of treatment to the first progression of the patient's diseaseTime based on RECIST V1.1.
Time frame: up to approximately 3 years
The incidence of disease progression within the first 9 months of the patient's treatment
Time frame: 2 years
Proportion of patients surviving from the start of enrollment to the full 18 months of follow-up.
Contact information is provided by the study sponsor or research team.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Other
Infusional FOLFOX Plus Camrelizumab and Apatinib Versus HAIC-FOLFOX Plus Camrelizumab and Apatinib for Hepatocellular Carcinoma of BCLC C Stage: A Multi-center Randomized Phase III Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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