Clinical trial NCT05681390: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pancreatic Neoplasms
Keywords: Advanced
second-line treatment
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: MedianProgression free survival(mPFS)
timeFrame: from enrollment to disease progression or death from any cause, up to 24 months
Secondary outcomes:
measure: objective response rate(ORR)
timeFrame: from enrollment to disease progression or death from any cause,up to 24 months
measure: Median Overall Survival
timeFrame: from enrollment to death from any cause,up to 24 months
measure: disease control rate(DCR)
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xian Jiaotong University
state: Shanxi
Study officials:
affiliation: First hospital of Xi'an Jiaotong University
name: EnXiao Li, Doctor
role: PRINCIPAL_INVESTIGATOR
References: