Tislelizumab With Anlotinib And Chemotherapy For Second-line Treatment Of Pancreatic Cancer

Study Overview

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

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

Pancreatic Neoplasms

DRUG: Tislelizumab

XJTU1AF2020LSL-010X1

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-12-09	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-06-07
First Submitted that Met QC Criteria 2022-12-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-06-09
First Posted (ACTUAL) 2023-01-12	Results First Posted N/A	Last Verified 2022-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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.	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 toxici

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 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.

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 toxici

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
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
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
disease control rate(DCR)	document and assessment on baseline, at end of 2 treatment cycles(each cycle is 21 days）	up to 24 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Xuyuan Dong, Doctor

Phone Number: 86-15332304217

Email: 2005dongxuyuan@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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:

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: EnXiao Li, Doctor, First hospital of Xi'an Jiaotong University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record