This was a single-arm, prospective study to investigate the efficacy and safety of fruquintinib combined with sintilimab in the second-line treatment of Chinese patients with advanced gastric/GEJ adenocarcinoma.
Patients with adenocarcinoma of the gastro-esophageal junction or the stomach who have documented progression after being treated with a 1st line chemotherapy can be included. All patients will receive a second line therapy with fruquintinib and sintilimab, a checkpoint inhibitor. Clinical and radiographic assessment will be performed regularly. Patients will be treated until disease progression, untolerable toxicity or withdrawal of consent.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Fruquintinib will be administrated as 4mg orally, once daily for 2 weeks on/1 week off.
Sintilimab will be administrated as 200mg once every 3 weeks.
Wuhan Union Hospital, China
Wuhan, Hubei, China
Objective Response Rate (ORR)
ORR is 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: from date of randomization until the date of progressive disease or EOT due to any cause, assessed up to 1 year
Progression-Free Survival (PFS)
PFS is defined as the time from randomization 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: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Time frame: from date of randomization until the date of death due to any cause, assessed up to 2 years
Disease Control Rate (DCR)
DCR is 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: from date of randomization until the date of progressive disease or EOT due to any cause, assessed up to 1 year
Duration of Response (DoR)
DoR is defined as the time how long response lasts
Time frame: from date of the first documentation of response to the date of the first documentation of objective tumor progression or death due to any cause, whichever came first, assessed up to 1 year
Adverse Event (AEs)
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Safety will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0.
Time frame: from the date of first dose to the 30 days post the last dose