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Tislelizumab With Anlotinib and Chemotherapy for Second-line Treatment of Pancreatic Cancer

Primary Purpose

Pancreatic Neoplasms

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tislelizumab
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Neoplasms focused on measuring Advanced, second-line treatment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Xian Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tislelizumab Combined With Anlotinib and Chemotherapy

Arm Description

Tislelizumab iv drip, every 3 weeks; Anlotinib, oral,once a day; chemotherapy will be choiced by investigator according guildline.

Outcomes

Primary Outcome Measures

MedianProgression free survival(mPFS)
assessment by RECIST v1.1,at end of per 2 treatment cycles(each cycle is 21 days)

Secondary Outcome Measures

objective response rate(ORR)
assessment by RECIST v1.1,at end of per 2 treatment cycles(each cycle is 21 days)
Median Overall Survival
document and assessment on baseline, at end of 2 treatment cycles(each cycle is 21 days)
disease control rate(DCR)
document and assessment on baseline, at end of 2 treatment cycles(each cycle is 21 days)

Full Information

First Posted
December 9, 2022
Last Updated
June 7, 2023
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT05681390
Brief Title
Tislelizumab With Anlotinib and Chemotherapy for Second-line Treatment of Pancreatic Cancer
Official Title
A Prospective, One-arm, Phase II Clinical Study of Tislelizumab Combined With Anlotinib and Investigator-selected Chemotherapy for Second-line Treatment of Advanced or Metastatic Pancreatic Cancer: a
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasms
Keywords
Advanced, second-line treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tislelizumab Combined With Anlotinib and Chemotherapy
Arm Type
Experimental
Arm Description
Tislelizumab iv drip, every 3 weeks; Anlotinib, oral,once a day; chemotherapy will be choiced by investigator according guildline.
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
Beigene
Intervention 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
Primary Outcome Measure Information:
Title
MedianProgression free survival(mPFS)
Description
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
Secondary Outcome Measure Information:
Title
objective response rate(ORR)
Description
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
Title
Median Overall Survival
Description
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
Title
disease control rate(DCR)
Description
document and assessment on baseline, at end of 2 treatment cycles(each cycle is 21 days)
Time Frame
up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuyuan Dong, Doctor
Phone
86-15332304217
Email
2005dongxuyuan@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EnXiao Li, Doctor
Organizational Affiliation
First hospital of Xi'an Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Xian Jiaotong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enxiao Li
First Name & Middle Initial & Last Name & Degree
Xuyuan Dong, Doctor
Email
2005dongxuyuan@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Tislelizumab With Anlotinib and Chemotherapy for Second-line Treatment of Pancreatic Cancer

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