This is a single-center, single-arm, open-label clinical study, to explore the efficacy and safety of fruquintinib combined with tislelizumab and HAIC (hepatic arterial infusion chemotherapy) in patients with colorectal liver metastases cancer (CRLM) who failed standard therapy.
Liver is the most common metastatic site in patients with colorectal cancer (CRC) and the leading cause of death in patients. Surgery is the best way to cure CRLM, but few patients can receive surgery, and patients prone to recurrence after surgery. It is an urgent topic to choose an effective treatment method with less side effects for CRLM patients. HAIC is a unique and effective treatment option for CRLM patients. Fruquintinib is a small molecule angiogenesis inhibitor, and has been recommended for third-line treatment of metastatic colorectal cancer (mCRC). Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody, meanwhile, tislelizumab shows significant and durable antitumor activity in patients with CRC, and is well tolerated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
After successful percutaneous hepatic artery cannulation, superior mesenteric arteriogram and hepatic arteriogram were performed, and after confirming that the subjects were eligible for enrollment according to the results, the hepatic artery was cannulated to the predetermined position. The catheter was connected to a syringe pump in the ward for continuous pumping of drugs.
3mg, qd, po, 21 days for a cycle, Suspend medication on the day of HAIC
200mg, ivgtt, d1, 21 days for a cycle
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
objective response rate (ORR)
Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
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 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) as assessed by investigator
Time frame: 24 months
Progression-Free Survival rate at 6 months
The proportion of patients who did not experience disease progression or death from treatment initiation to 6 months
Time frame: 6 months
overall survival (OS)
OS is the time from enrollment to death due to any cause.
Time frame: 24 months
Adverse events as assessed by NCI CTCAE v5.0
overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use
Time frame: 24 months
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2 mg/m2, hepatic artery infusion for 15 min, d1, 4-6 Cycles
85 mg/m2, hepatic artery infusion for 2 h, d1, 4-6 Cycles
120mg/m2, hepatic artery perfusion for 30-90min, d1, 4-6 Cycles