Sintilimab Combined With Chemotherapy and Radiotherapy in Patients With Inoperable Pancreatic Cancer
Recruiting · NCT06050317 · Interventional (participants receive a specific treatment) · Lead sponsor: Shandong Cancer Hospital and Institute
View the official record on ClinicalTrials.gov →Interventions studied
Sintilimab Plus mFFN or NALIRIFOX and Radiation
What this trial is about
Hypothesis: Survival benefits could be found in Sintilimab plus chemotherapy and radiotherapy in patients with inoperable pancreatic cancer.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- ECOG PS 0-1
- Pathological tissue-confirmed unresectable locally advanced pancreatic cancer
- Pancreatic cancer patients who have not received systemic anti-tumor therapy
- Primary pancreatic cancer or at least one measurable lesion specified by RECIST1.1 standards
- A life expectancy of \> 3 months
- Blood routine examination: Absolute neutrophil count (ANC) ≥ 1.0 ×109 cells/L, platelets ≥ 75×109 cells/L, hemoglobin ≥ 9.0 g/dl
- AST\<2.5 × ULN(Upper Limit of Normal), ALT\<2.5 × ULN,creatinine ≤1.5xULN, total bilirubin \< ≤1.5 X ULN.
Exclusion criteria
- Diagnosed with other malignant diseases other than pancreatic cancer within three years before enrollment
- Patients who are currently participating in interventional clinical research treatment or have received other research drugs or used research devices within four weeks before enrollment
- Patients who have previously received anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or another drug that stimulates or synergistically inhibits T-cell receptors
- Patients who have received systemic treatment with Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects within two weeks before enrollment
- Abnormal results of blood routine examinations and liver and kidney and coagulation tests
- Abnormal function of major organs (14 days before enrollment)
- Women who are pregnant
- Inability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document.
Where it is running
1 location listed.
- Department of Radiation Oncology, Shandong Cancer Hospital and Institute - Jinan, Shandong, China