A Phase 2 interventional study of Tislelizumab in Pancreatic Neoplasms, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-06-09.
Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Phase 2, Interventional, and Treatment
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
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's planned enrollment of 30 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Neutrophils (ANC) ≥ 1.5×109/L, platelets (PLT) ≥ 80×109/L, hemoglobin (HGB) ≥ 80g/L; Serum creatinine (Cr) ≤ 1.5 × upper limit of normal value; total bilirubin (TBIL) ≤ 2.5 × upper limit of normal value, Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤2.5× upper limit of normal value;
Exclusion Criteria:
Tislelizumab iv drip, every 3 weeks; Anlotinib, oral,once a day; chemotherapy will be choiced by investigator according guildline.
Drug: Tislelizumab
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
Also known as: Beigene
MedianProgression 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
Plan to share: No
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First Affiliated Hospital Xi'an Jiaotong University