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Trial Title:
Tislelizumab With Anlotinib and Chemotherapy for Second-line Treatment of Pancreatic Cancer
NCT ID:
NCT05681390
Condition:
Pancreatic Neoplasms
Conditions: Official terms:
Pancreatic Neoplasms
Tislelizumab
Conditions: Keywords:
Advanced
second-line treatment
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
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
Arm group label:
Tislelizumab Combined With Anlotinib and Chemotherapy
Other name:
Beigene
Summary:
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
Detailed description:
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Advanced or metastatic pancreatic adenocarcinoma diagnosed by pathology;
- Previously received a standard first-line chemotherapy regimen of pancreatic cancer
- Age ≥ 18 and≤ 75 years old;
- Expected survival ≥ 3 months;
- ECOG score 0-1;
- Child-Pugh score < 8;
- There is at least one measurable tumor lesion: the long diameter is ≥10 mm, and the
short diameter of lymph nodes is ≥15 mm;
- The results of liver and kidney function and blood routine examination within 1 week
before enrollment meet the following conditions:
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;
- The patient voluntarily participated in this study and signed the informed consent
form.
Exclusion Criteria:
- Received other immunotherapy previously(including immune checkpoint inhibitor
PD-1/PDL1 and other immune checkpoint inhibitors) and/or anti-angiogenic drugs
(including anti-VEGFR monoclonal antibody and anti-angiogenic small molecule kinase
inhibitors) ; Known to be severely allergic to the drugs used in the study of
tislelizumab and anlotinib;
- Patients with obstructive jaundice who cannot reach TBIL ≤ 2.5 times the upper limit
of normal value after surgical intervention;
- Patients with biliary obstruction that may occur or worsen within 4 to 6 weeks;
- Obvious blood coagulation disorder, active bleeding and bleeding tendency;
- There is a history of other malignant tumors within 5 years (adequately treated skin
basal cell carcinoma, cervical in situ);
- Interstitial pneumonia or pulmonary fibrosis;
- Uncontrollable pleural effusion or ascites;
- Severe uncontrolled medical diseases, acute infections, recent history of myocardial
infarction (within 3 months);
- During pregnancy or breastfeeding, and those who refuse to take appropriate
contraceptive measures during the test;
- Patients judged by the investigator to be inappropriate to participate in this
study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Xian Jiaotong University
Address:
City:
Xi'an
Zip:
710004
Country:
China
Status:
Recruiting
Contact:
Last name:
Enxiao Li
Contact backup:
Last name:
Xuyuan Dong, Doctor
Email:
2005dongxuyuan@163.com
Start date:
January 1, 2023
Completion date:
June 30, 2025
Lead sponsor:
Agency:
First Affiliated Hospital Xi'an Jiaotong University
Agency class:
Other
Source:
First Affiliated Hospital Xi'an Jiaotong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05681390
