Status:
RECRUITING
Sintilimab Combined With Chemotherapy and Radiotherapy in Patients With Inoperable Pancreatic Cancer
Lead Sponsor:
Shandong Cancer Hospital and Institute
Conditions:
Pancreas Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Hypothesis: Survival benefits could be found in Sintilimab plus chemotherapy and radiotherapy in patients with inoperable pancreatic cancer.
Detailed Description
Background and aim: Pancreatic cancer, characterized by its aggressive nature and dismal prognosis, exhibits one of the lowest 5-year survival rates among all solid tumors, standing at a mere 7%. Ala...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 18 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06050317
Start Date
August 18 2023
End Date
August 18 2026
Last Update
July 22 2025
Active Locations (1)
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1
Department of Radiation Oncology, Shandong Cancer Hospital and Institute
Jinan, Shandong, China, 0531