This study was an observational cohort study to investigate the efficacy predictors of fuquinitinib combined with anti-PD-1 monoclonal antibody for third-line treatment and above in Chinese patients with advanced colorectal cancer.
Patients with histologically confirmed metastatic or unresectable MSS/MSI-L/pMMR colorectal adenocarcinoma refractory to or intolerant of fluorouracil, oxaliplatin and irinotecan based systemic treatment, were enrolled in the study. All patients will receive a third line therapy with fruquintinib and anti-PD-1 antibody. Clinical and radiographic assessment will be performed regularly. Patients will be treated until disease progression, untolerable toxicity or withdrawal of consent.
Study Type
OBSERVATIONAL
Enrollment
100
In radiotherapy group, the modality of radiotherapy was conventional radiotherapy (CRT) or stereotactic body radiotherapy (SBRT) for cancer.
Min Jin
Wuhan, Hubei, China
RECRUITINGProgression-Free Survival (PFS)
PFS is defined as the time from randomization to the first documented disease
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
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
Adverse Event (AEs)
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
Gut microbiome analysis
To explore the association of gut microbiome and the efficacy of the treatment
Time frame: 16S ribosomal RNA (rRNA) sequencing for the baseline fecal samples of some patients
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