This is a phase II trial to evaluate the efficacy and safety of immune checkpoint inhibitors in combination with axitinib for previously treated advanced collecting duct carcinoma.
Fully understand and be willing to provide written informed consent.
Male or female with age ≥ 18 years and <80 years.
Have received prior systemic therapy after previous metastasis for collecting duct carcinoma, histologically confirmed diagnosis of unresectable, recurrent or metastatic collecting duct carcinoma.
Having at least one measurable disease per RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if re-progression has been demonstrated.
Prior Anti-PD-1, PD-L1 or axitinib.
Has participated or is currently participating in a trial of investigational agent within 4 weeks prior to the first dose of study treatment, unless observational (non-interventional) clinical study or follow-up period of interventional study.
Had major surgery (judged by investigators) within 4 weeks prior to the first dose of study treatment or has not recovered from prior surgery.
Has traditional Chinese medicine or Chinese patent medicine preparation with anti-cancer indication within 2 weeks prior to the first dose of study treatment.
Single group
PD-(L)1 inhibitor
DrugToripalimab 240mg or Tirelizumab 200mg or pembrolizumab 200mg intravenously every 3 weeks
Axitinib
Drugaxitinib 5mg orally twice daily
ORR assessed by investigators per RECIST 1.1
The treatment effect of with ICI plus axitinib will be assessed using RECIST 1.1 to determine tumor response.
PFS assessed by investigators per RECIST 1.1
The treatment effect of with ICI plus axitinib will be assessed using RECIST 1.1 to determine tumor response.
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