Pancreatic ductal adenocarcinoma
Conditions
Interventions
Treatment Group:Metronomic Capecitabine with Camrelizumab and Apatinib Mesylate
Sponsors
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age is 18 years or older; 2.Pathologically confirmed pancreatic adenocarcinoma; 3.As determined by the investigator, second-line treatment for advanced pancreatic cancer has failed; or the patient has a poor performance status (PS score >1), and the investigator considers that the patient cannot tolerate a second-line regimen with two or more drugs. 4.Performance status PS score 0-2; 5.Expected survival period >= 3 months; 6.According to the RECIST1.1 criteria, the patient has at least one measurable lesion present; 7.Good organ function levels: • ANC>=1.5×10^9/L; • PLT>=75×10^9/L; • Hb>=80 g/L; • TBIL1.5×ULN, then Ccr>50ml/min (calculated by Cockcroft-Gault formula); • LVEF>=50%; • Fridericia corrected QT interval (QTcF) <450 ms for males, <470 ms for females; 8.After assessment by the researcher, the participant is able to comply with the trial protocol; 9.Voluntarily participate in this clinical trial, understand the research procedures, and can sign the informed consent form in writing;
Exclusion criteria
Exclusion criteria: 1.Patients who have developed resistance after treatment with capecitabine and apatinib are not recommended for enrollment unless more than 6 months have passed since the last dose, in which case they can continue to challenge its use; patients who have previously undergone immunotherapy (regardless of whether or not they used camrelizumab) can cross-line use or switch to camrelizumab to continue challenging its use. 2.Received chemotherapy, radiotherapy, immunotherapy, biologics, or endocrine therapy for anti-tumor treatment, or other investigational drugs not yet on the market within 4 weeks before the first use of the study drug; 3.Within 4 weeks before the first use of the study drug, the subject has undergone major organ surgery (excluding biopsy) or experienced significant trauma, or requires elective surgery during the trial period; 4.Use of steroid hormones (prednisone equivalent) greater than 20 mg/day for more than 14 consecutive days within 14 days before the first use of the study drug; 5.Adverse reactions from previous anti-tumor treatments have not yet recovered to CTCAE 5.0 grade <=1 (excluding alopecia and other toxicities determined by the investigator to pose no safety risk). 6.Past or current retinal vein occlusion (RVO) or high-risk factors (such as uncontrolled glaucoma or high intraocular pressure, history of hyper-viscous blood syndrome or hypercoagulable state); 7.History of active major bleeding; 8.Uncontrolled hypertension; 9.Severe unhealed wounds or fractures; 10.Ulcer, bowel perforation or intestinal obstruction; 11.After evaluation by researchers, there are contraindications for drug prophylaxis of thromboembolism; 12.Central nervous system metastasis, leptomeningeal metastasis; 13.Past medical history or physical examination reveals central nervous system diseases, except for those that have been adequately treated (such as primary brain tumors, uncontrolled seizures, or stroke); 14.Active viral, bacterial, or fungal infections requiring systemic treatment (such as pneumonia); 15.Has a history of active tuberculosis; 16.A history of immunodeficiency, including HIV test positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation, or allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation; 17.Had active autoimmune diseases requiring systemic treatment within the past 2 years; 18.Vaccination within 30 days before treatment, including intranasal influenza vaccine, except for seasonal influenza vaccine; 19.Within 3 months prior to treatment, there were cardiovascular diseases, including: unstable angina; clinically significant or drug-treated malignant arrhythmias; myocardial infarction; Class III-IV heart failure; transient ischemic attack; thromboembolic events (such as deep vein thrombosis, pulmonary embolism, etc.), and any other cardiac conditions deemed by the investigator as unsuitable for participation in this trial. 20.Pre-cancerous blood disorders, such as myelodysplastic syndromes; 21.Clinical history of or pre-existing interstitial lung disease, such as non-infectious pneumonia or pulmonary fibrosis, or evidence of interstitial lung disease found on baseline chest CT scan; 22.Positive baseline pregnancy test in female patients who are pregnant, breastfeeding, or have childbearing potential; 23.Patients who have had other primary malignant tumors within the past 5 years, except for locally curable tumors (such as basal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;safety of treatment; | — |
Countries
China
Contacts
Public ContactTingbo Liang
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed