Combining Tislelizumab with Nab-paclitaxel and Gemcitabine for Recurrent Pancreatic Cancer
Prospective Exploratory Study of Tislelizumab Combined With Nab-paclitaxel and Gemcitabine for Postoperative Recurrence of Pancreatic Cancer
This study is testing if a new combination of immune therapy and chemotherapy can help people with recurrent pancreatic cancer feel better, depending on where their cancer has spread.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Changhai Hospital Academic / other |
| Drugs / interventions | Tislelizumab, chemotherapy |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT04902261 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Tislelizumab, an immune checkpoint inhibitor, in combination with Nab-paclitaxel and Gemcitabine for patients with recurrent pancreatic cancer. The research focuses on understanding how different metastatic sites respond to this treatment, given the heterogeneity in tumor characteristics. Patients must have measurable lesions and have not received prior gemcitabine-based therapy after surgery. The study aims to determine if the efficacy of the treatment varies based on the type of metastasis present.
Who should consider this trial
Good fit: Ideal candidates include patients with confirmed postoperative recurrent pancreatic cancer who have not received gemcitabine-based treatment.
Not a fit: Patients with significant liver dysfunction or those who have received systemic treatment after recurrence may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment combination could improve outcomes for patients with recurrent pancreatic cancer.
How similar studies have performed: Other studies have shown promise with similar immunotherapy and chemotherapy combinations, but this specific approach is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with radiologically or histologically confirmed postoperative Recurrent Pancreatic Cancer * Patients with at least one measurable lesion (according to RECIST 1.1 criteria); * Have not received gemcitabine-based regimen after surgery * No systemic treatment after diagnosis of recurrence * ECOG score 0-1 * Expected survival ≥ 3 months; * Liver function is essentially normal: absolute neutrophil count \> 1500/mm ³; platelet count \> 100,000/mm ³; creatinine less than 1.5 times the upper limit of normal or calculated creatinine clearance (CRCI) \> 45 mL/min; total bilirubin ≤ 2.0 mg/dL; aspartate aminotransferase (AST) and alanine aminotransferase less than 2.5 times the upper limit of normal * Appropriate to participate in this trial as assessed by the investigator before entering the study * Male and female subjects of childbearing potential must agree to use an effective method of contraception throughout the study * Signed Informed Consent Form Exclusion Criteria: * Patients who only undergo abdominal laparotomy but do not undergo resection of pancreatic tumor tissue * Received gemcitabine-based regimen after surgery * Systemic treatment after diagnosis of recurrence * Patients with previous allergic reactions to similar drugs * Pregnant or lactating patients * Presence of pericardial effusion, uncontrolled pleural effusion, or clinically significant ascites at screening (including detectable ascites or ascites requiring puncture and aspiration on physical examination at screening) * History of interstitial lung disease, pneumonitis, or uncontrolled systemic disease, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc * Patients with severe cardiovascular diseases within 12 months before enrollment, such as symptomatic coronary heart disease, ≥ grade II congestive heart failure, uncontrolled arrhythmia, myocardial infarction, etc * Presence of any active immunodeficiency or autoimmune disease and/or history of any immunodeficiency or autoimmune disease that may recur at screening (e.g., hypothyroidism or hyperthyroidism, interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, etc) * Use of steroids or other systemic immunosuppressive therapy 14 days prior to enrollment * Patients with other previous malignancies who are not cured * Immunodeficient patients, such as HIV-positive * Uncontrollable psychosis
Where this trial is running
Shanghai
- Changhai Hospital — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Gang Jin, Doctor — Changhai Hospital
- Study coordinator: Shiwei Guo, Doctor
- Email: gestwa@163.com
- Phone: +8618621500666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.