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

Pancreatic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05681390
• Other study ID #: XJTU1AF2020LSL-010X1
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: September 2022
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Xuyuan Dong, Doctor
• Phone: 86-15332304217
• Email: 2005dongxuyuan[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Xian Jiaotong University	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MedianProgression free survival(mPFS)	assessment by RECIST v1.1,at end of per 2 treatment cycles(each cycle is 21 days)	from enrollment to disease progression or death from any cause, up to 24 months
Secondary	objective response rate(ORR)	assessment by RECIST v1.1,at end of per 2 treatment cycles(each cycle is 21 days)	from enrollment to disease progression or death from any cause,up to 24 months
Secondary	Median Overall Survival	document and assessment on baseline, at end of 2 treatment cycles(each cycle is 21 days)	from enrollment to death from any cause,up to 24 months
Secondary	disease control rate(DCR)	document and assessment on baseline, at end of 2 treatment cycles(each cycle is 21 days)	up to 24 months