This is a prospective, one-arm, phase II clinical study of Tislelizumab Combined With Anlotinib and Chemotherapy for Second-line Treatment of Advanced or Metastatic Pancreatic Cancer
This is a single-arm, open-label, clinical trial of tislelizumab in combination with anlotinib and investigator-selected chemotherapy for second-line treatment of patients with advanced or metastatic pancreatic cancer. Patients with histopathologically or cytologically confirmed unresectable, recurrent or metastatic pancreatic cancer are planned to be recruited. Systemic medical antineoplastic therapy previously treated with first-line chemotherapy, meeting the inclusion and exclusion criteria of this study, and giving tislelizumab and anlotinib in combination with investigator 's choice of second-line chemotherapy regimen
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Tislelizumab 200mg iv drip, d1, Q3W;Anlotinib tablet : 10mg, PO, QD; Chemotherapy: selected by investigator following CSCO or NCCN pancreatic adenocarcinoma guideline; Tislelizumab and Anlotinib continue unless disease progression or intolerance to toxicity, chemotherapy continue upto 8 cycles unless disease progression or intolerance to toxicity
The First Affiliated Hospital of Xian Jiaotong University
Xi’an, Shanxi, China
RECRUITINGMedianProgression free survival(mPFS)
assessment by RECIST v1.1,at end of per 2 treatment cycles(each cycle is 21 days)
Time frame: from enrollment to disease progression or death from any cause, up to 24 months
objective response rate(ORR)
assessment by RECIST v1.1,at end of per 2 treatment cycles(each cycle is 21 days)
Time frame: from enrollment to disease progression or death from any cause,up to 24 months
Median Overall Survival
document and assessment on baseline, at end of 2 treatment cycles(each cycle is 21 days)
Time frame: from enrollment to death from any cause,up to 24 months
disease control rate(DCR)
document and assessment on baseline, at end of 2 treatment cycles(each cycle is 21 days)
Time frame: up to 24 months
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