Influence Factors of PD-1 Therapeutic Efficacy in Advanced Pancreatic Cancer

Brief summary public domain (ClinicalTrials.gov)

The early diagnosis rate of pancreatic cancer is low and most patients rely on palliative chemotherapy. However, the clinical benefit and objective response rate (ORR) of patients with first-line chemotherapy are low. Therefore,it is essential to develop new therapies to improve the survival of patients with pancreatic cancer.

Detailed description public domain (ClinicalTrials.gov)

In this study, patients with advanced pancreatic cancer who failed in the first-line chemotherapy will be included to receive anti-PD-1 monoclonal antibody treatment, and a high-throughput study with a small sample size will be carried out by using multiomics technology to capture the heterogeneity of response to PD-1 therapy in patients with pancreatic cancer.The investigators choose two time points: after chemotherapy failure (before PD-1 therapy) and during efficacy evaluation（after PD-1 therapy）, to obtain in situ samples of pancreatic cancer tissues by EUS-FNA.The samples are tested by dynamic multi-omics studybefore and after treatment (including genomics, transcriptomics, metabonomics, proteomics, etc.).And combining the results with the drug reaction and clinical outcome of patients for a comprehensive analysis.The purpose of this study is to explore the potential biomarkers or omics of PD-1 therapy and lay the foundation for building a model to predict the effect of PD-1 therapy in patients with advanced pancreatic cancer.

Primary outcome public domain (ClinicalTrials.gov)

The difference of progression free survival (PFS). The time from random to the first occurrence of disease progression or death from any cause. Time frame: 1.5 years.

Secondary outcome public domain (ClinicalTrials.gov)

Disease control rate (DCR). Time frame: 1.5 years.

Secondary outcome public domain (ClinicalTrials.gov)

the quality of participants'life. Time frame: 1.5 years.

Eligibility public domain (ClinicalTrials.gov)

Criteria: Inclusion Criteria: 1. Age \> 18 years old, male or female; 2. Locally advanced or metastatic pancreatic ductal adenocarcinoma confirmed by histopathology / cytology of the primary and / or metastatic lesions and unsuitable for surgical resection; 3. The failure of first-line chemotherapy with gemcitabine or FOLFINOX, disease progression or intolerable severe toxicity; 4. The time from the end of the last chemotherapy should be more than 28 days; 5. According to the evaluation criteria of solid tumor efficacy(RECIST 1.1), there should be at least one measurable lesion (non nodular lesion with the longest diameter of 210 mm, or nodular lesion with the shortest diameter of more than 15 mm); 6. ECOG score:0\~2; 7. Hematology, biochemistry and organ function indexes meet the following requirements: * The absolute count of neutrophils (ANC) is more than 1.5x10% / L * Platelet count (PLT) ≥ 80x109/l * Hemoglobin (HB) ≥ 9.0 g/dl * TBIL is less than 2.0 ULN, albumin (ALB) 230g / L * In patients without liver metastasis, alanine transaminase (ALT) and / or aspartate -transaminase (AST) are less than 3.0 ULN * Patients with liver metastasis, ALT and / or ASTS \<5.0\*ULN * Serum creatinine (CREA) \< 1.5 x ULN, and creatinine clearance rate (CER) ≥ 30ml / min (Cockcroft-Gault); 8. Women of childbearing age receives negative pregnancy test within 14 days before treatment. Male and female patients of childbearing age and their sexual partners agree to use reliable contraceptive methods within 14 days before enrollment, during the study and within 60 days after drug withdrawal； 9. Patients voluntarily participate in this study, sign informed consent, have good compliance, and cooperate with follow-up. Exclusion Criteria: If any of the following criteria is met, the patient should be excluded: 1. Pancreatic ductal adenocarcinoma is diagnosed without histopathology / cytology; 2. The target lesion has received local non-drug therapy (including radiotherapy, physical and / or chemical ablation, etc.), and there is no imaging progression; 3. If the central nervous system metastasis is known, MRI should be performed to exclude it; 4. Patients with carcinoma of Vater's ampulla or adenocarcinoma of biliary tract; 5. Patients with partial or complete intestinal obstruction or complete biliary obstruction that cannot be relieved by active treatment; 6. Ascites increases gradually after 2 weeks of conservative treatment (such as diuresis, sodium restriction, excluding …

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 30 participants (estimated).