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

NCT05681390 | Unknown Phase 2

• 1 other identifier: XJTU1AF2020LSL-010X1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Pancreatic Neoplasms

Keywords

Advanced; second-line treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• objective response rate(ORR)

  from enrollment to disease progression or death from any cause,up to 24 months

• Median Overall Survival

  from enrollment to death from any cause,up to 24 months

• disease control rate(DCR)

  up to 24 months

Study Arms (1)

Tislelizumab Combined With Anlotinib and Chemotherapy

EXPERIMENTAL

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

Drug: Tislelizumab

Interventions

Tislelizumab 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

Also known as: Beigene

Tislelizumab Combined With Anlotinib and Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

The First Affiliated Hospital of Xian Jiaotong University

Xi’an, Shanxi, 710004, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

tislelizumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• EnXiao Li, Doctor

  First hospital of Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuyuan Dong, Doctor

CONTACT

86-15332304217; 2005dongxuyuan@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: January 12, 2023
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: June 9, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)