Hepatocellular Carcinoma
Conditions
Brief summary
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.
Detailed description
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
Interventions
PROCEDURETOMOX-HAIC
Oxaliplatin 85mg/m\^2 plus Raltitrexed 3mg/m\^2, 21 days for a cycle
DRUGSintilimab
200mg, ivgtt, d1, 21 days for a cycle
DRUGBevacizumab
7.5mg/kg, ivgtt, d1, 21 days for a cycle
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Be willing and able to provide written informed consent/assent for the trial. * Males or unpregnant females who age ≥ 18 years, ≤75 years. * The investigator believes the patient is capable of complying with the study protocol. * Histologically, cytologically or clinically confirmed advanced hepatocellular carcinoma. * is not a candidate for radical surgery * not received previous systemic treatment * patients must have at least one measurable lesion (RECIST 1.1) * ECOG PS：0-1, 14 days before enrollment * Child-Pugh A or Child-Pugh B ≤ 7, 14 days before enrollment
Exclusion criteria
* Prior history of other malignant tumors * Current or prior immunodeficiency disorders or autoimmune diseases * Subjects have untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk of bleeding * Subjects who are not available for follow-up or are participating in other clinical trials that have the potential to interfere with this study * Conditions considered unsuitable for inclusion by researchers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate (ORR) | 24 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | 24 months | 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 to progression (TTP) | 24 months | the time from randomization until first evidence of disease progression |
| disease control rate (DCR) | 24 months | 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 |
| overall survival (OS) | 24 months | OS is the time from enrollment to death due to any cause. |
| adverse event (AE) | 24 months | using the The NCI Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0) |
| Duration of response (DOR) | 24 months | defined as the time from randomization to disease progression or death in patients who achieve complete or partial response |
Countries
China
Contacts
Primary ContactLu Wang
Outcome results
None listed