Clinical trial · Interventional
Tislelizumab Combined 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
NCT04902261CI-TRIAL-00069294unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the efficacy of Tislelizumab combined with Nab-paclitaxel and Gemcitabine in the treatment of recurrent pancreatic cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Nab paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tislelizumab combined with Nab-paclitaxel and Gemcitabine
- interventionNames
- Drug: Tislelizumab
- Drug: Nab paclitaxel
- Drug: Gemcitabine
- type
- ACTIVE_COMPARATOR
- label
- Nab-paclitaxel and Gemcitabine
- interventionNames
- Drug: Nab paclitaxel
- Drug: Gemcitabine
Primary outcomes (1)
- measure
- 1-Year Survival Rates
- timeFrame
- Up to 2 years
- description
- The proportion of patients who survive more than 1 year after treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.