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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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;