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

NCT ID: NCT05681390

Last Updated: 2023-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-06-30

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

Conditions

Pancreatic Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tislelizumab Combined With Anlotinib and Chemotherapy

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

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Beigene

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

EnXiao Li, Doctor

Role: PRINCIPAL_INVESTIGATOR

First hospital of Xi'an Jiaotong University

Locations

The First Affiliated Hospital of Xian Jiaotong University

Xi’an, Shanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xuyuan Dong, Doctor

Role: CONTACT

2005dongxuyuan@163.com

86-15332304217

Facility Contacts

Enxiao Li

Role: primary

Xuyuan Dong, Doctor

Role: backup

2005dongxuyuan@163.com

Other Identifiers

XJTU1AF2020LSL-010X1

Identifier Type: -

Identifier Source: org_study_id