Combination treatment for advanced pancreatic cancer

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

This study is testing a new combination of treatments for people with advanced pancreatic cancer who have already tried other chemotherapy to see if it helps them.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University (other)
• Drugs / interventions: tislelizumab, anlotinib, chemotherapy, immunotherapy
• Locations: 1 site (Xi'an, Shanxi)
• Trial ID: NCT05681390 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of tislelizumab combined with anlotinib and chemotherapy as a second-line treatment for patients with advanced or metastatic pancreatic cancer. It is a single-arm, open-label study that aims to recruit patients who have previously received first-line chemotherapy and have confirmed unresectable pancreatic cancer. Participants will receive the combination therapy to evaluate its effectiveness and safety in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with advanced or metastatic pancreatic adenocarcinoma who have previously undergone first-line chemotherapy.

Not a fit: Patients with resectable pancreatic cancer or those who have not received prior chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for patients with advanced pancreatic cancer who have limited treatment choices.

How similar studies have performed: Other studies have explored similar combination therapies in pancreatic cancer, showing promising results, but this specific combination is relatively novel.

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.

Where this trial is running

Xi'an, Shanxi

• The First Affiliated Hospital of Xian Jiaotong University — Xi'an, Shanxi, China (RECRUITING)

Study contacts

• Principal investigator: EnXiao Li, Doctor — First hospital of Xi'an Jiaotong University
• Study coordinator: Xuyuan Dong, Doctor

Conditions: Pancreatic Neoplasms, Advanced, second-line treatment