This is a single-center, single-arm, phase II clinical study, to explore the efficacy and safety of modified TOMOX-HAIC combined with sintilimab and bevacizumab biosimilar as first line treatment in patients with advanced hepatocellular carcinoma.
Hepatocellular carcinoma (HCC) is one of the most common malignant tumors worldwide.The IMbrave150 study and the Orient-32 study demonstrated that PD-1 in combination with bevacizumab confers better survival outcomes in advanced hepatocellular carcinoma. In addition, HAIC combined with targeted therapy and immunotherapy has shown good safety and encouraging efficacy. Oxaliplatin-based FOLFOX regimen is currently the mainstream HAIC chemotherapy regimen (FOLFOX HAIC) in China. The results of the previous study confirmed that raltitrexed shows promising antitumor activity and safety in hepatocellular carcinoma. Also, TOMOX-HAIC regimen can significantly shorten the infusion duration and is expected to improve the patient experience, quality of life, and adherence while ensuring the efficacy. In this clinical trial, patients will receive TOMOX-HAIC combined with Sintilimab and bevacizumab biosimilar. The primary endpoint is overall response rate. The secondary endpoint are disease control rate, time to progression, duration of response, overall survival, and safety
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Oxaliplatin 85mg/m\^2 plus Raltitrexed 3mg/m\^2, 21 days for a cycle
200mg, ivgtt, d1, 21 days for a cycle
7.5mg/kg, ivgtt, d1, 21 days for a cycle
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGobjective response rate (ORR)
ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1. and mRECIST
Time frame: 24 months
disease control rate (DCR)
DCR was defined as the percentage of participants who have a confirmed complete response（CR） or partial response（PR） or stable disease（SD） per RECIST 1.1 and mRECIST as assessed by investigator
Time frame: 24 months
Progression-Free Survival (PFS)
PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) and mRECIST as assessed by investigator
Time frame: 24 months
Time to progression (TTP)
the time from randomization until first evidence of disease progression
Time frame: 24 months
Duration of response (DOR)
defined as the time from randomization to disease progression or death in patients who achieve complete or partial response
Time frame: 24 months
overall survival (OS)
OS is the time from enrollment to death due to any cause.
Time frame: 24 months
adverse event (AE)
using the The NCI Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0)
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Time frame: 24 months