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Sintilimab Combined With Chemotherapy and Radiotherapy in Patients With Inoperable Pancreatic Cancer

RECRUITINGPhase 2Sponsored by Shandong Cancer Hospital and Institute
Actively Recruiting
PhasePhase 2
SponsorShandong Cancer Hospital and Institute
Started2023-08-18
Est. completion2025-08-18
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted

Summary

Hypothesis: Survival benefits could be found in Sintilimab plus chemotherapy and radiotherapy in patients with inoperable pancreatic cancer.

Eligibility

Age: 18 Years – 75 YearsHealthy volunteers accepted
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.

Conditions2

CancerPancreas Cancer

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