Influence Factors of PD-1 Therapeutic Efficacy in Advanced Pancreatic Cancer (NCT05201729) | Clinical Trial Compass
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Influence Factors of PD-1 Therapeutic Efficacy in Advanced Pancreatic Cancer
China30 participantsStarted 2021-08-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age \> 18 years old, male or female;
✓. Locally advanced or metastatic pancreatic ductal adenocarcinoma confirmed by histopathology / cytology of the primary and / or metastatic lesions and unsuitable for surgical resection;
✓. The failure of first-line chemotherapy with gemcitabine or FOLFINOX, disease progression or intolerable severe toxicity;
✓. The time from the end of the last chemotherapy should be more than 28 days;
✓. 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);
✓. ECOG score:0\~2;
✓. Hematology, biochemistry and organ function indexes meet the following requirements:
✓. 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；
Exclusion criteria
✕. Pancreatic ductal adenocarcinoma is diagnosed without histopathology / cytology;
✕. The target lesion has received local non-drug therapy (including radiotherapy, physical and / or chemical ablation, etc.), and there is no imaging progression;
. If the central nervous system metastasis is known, MRI should be performed to exclude it;
✕. Patients with carcinoma of Vater's ampulla or adenocarcinoma of biliary tract;
✕. Patients with partial or complete intestinal obstruction or complete biliary obstruction that cannot be relieved by active treatment;
✕. Ascites increases gradually after 2 weeks of conservative treatment (such as diuresis, sodium restriction, excluding ascites drainage);
✕. In the past 5 years, patients had a history of other malignant tumors, except for the following two cases: a)After other malignant tumors treated by a single operation, 5-year disease-free survival (DFS) was achieved;b)Cured basal cell carcinoma of the skin and cured carcinoma in situ of the cervix;