Pancreatic Cancer
Conditions
Interventions
Experimental group:Chidamide + Anlotinib + AG Regimen
Control group:AG Regimen
Phase I Single Arm Set:Chidamide + Anlotinib + AG Regimen
Sponsors
The Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be enrolled in this study. (1) Age >= 18 years; (2) Patients with histologically or cytologically confirmed locally progressive or metastatic or locally recurrent pancreatic cancer with an expected survival time > 3 months; (3) Prior treatment: 1) patients who have not undergone prior systemic therapy for locally advanced/metastatic pancreatic cancer; 2) patients who have undergone prior radical pancreatic cancer surgery or postoperative adjuvant therapy for recurrent metastatic progression after the completion of therapy, and who have undergone prior gemcitabine-based regimens are not eligible for inclusion. 3) Treatment with palliative radiotherapy and anti-tumor herbal preparations is permitted, but must be terminated at least two weeks prior to the initiation of the medication; (4) ECOG score of 0-1; (5) At least one target lesion measurable by CT or MRI according to RECIST 1.1; (6) Female subjects of childbearing potential or male subjects whose partner is a female of childbearing potential should be using effective contraception from at least 1 month prior to the first dose of study drug to 6 months after the last dose of study drug; (7) Have good organ and bone marrow function, with the following test results to be completed within 7 days prior to the first study treatment: routine blood tests (no transfusion or hematopoietic stimulating factor therapy within 14 days prior to the test): neutrophil count (ANC) >= 1.5 x 109/L (1,500/mm3), platelets >= 100 x 109/L (100,000/mm3), and Hemoglobin (Hgb) >=9.0 g/dL (90g/L); Liver function tests: alanine aminotransferase (ALT) and azelaic aminotransferase (AST) =60 mL/min; Coagulation function tests: prothrombin time and partial thromboplastin time <=1.5×ULN.
Exclusion criteria
Exclusion criteria: Enrollment can be excluded by meeting any one of the following conditions: (1) Have other serious diseases or medical history of cardiovascular, hepatic, renal, gastrointestinal, neurologic, endocrine, respiratory, and psychiatric abnormalities that, in the opinion of the study physician, make the participant unsuitable; (2) Received antitumor therapy such as chemotherapy, biotherapy, targeted therapy, immunotherapy, or other unlisted clinical investigational drugs or treatments within 4 weeks prior to the first dose of study drug; (3) Subjects who have received radiation therapy within 4 weeks prior to the first dose of study drug; (4) Subjects who have undergone major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks prior to the first dose of study drug, or who require elective surgery; (5) Other concurrent malignancies within 5 years prior to the first dose of study drug, except adequately treated carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancer, localized prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, and papillary thyroid cancer after radical surgery; (6) Subjects with known or suspected interstitial pneumonitis; the presence of other moderate-to-severe lung disease that may interfere with the detection or management of drug-related pulmonary toxicity within 3 months prior to the first dose of the drug and that severely affects respiratory function, including, but not limited to, idiopathic pulmonary histofibrosis, mechanized pneumonitis/obstructive fine bronchitis, pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), obstructive/ restrictive lung disease, etc.; and any autoimmune, connective tissue or inflammatory disease with pulmonary involvement, such as rheumatoid arthritis, dry syndrome, tuberculosis, etc., or prior total lung resection, etc. Subjects with grade >=3 interstitial pneumonitis during prior systemic antitumor therapy will not be allowed to enroll in this study; (7) Severe cardiovascular disease, including but not limited to: severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, degree II-III atrioventricular block, etc.; QTc >450ms (males) or QTc >470ms (females) on 12-lead electrocardiogram at rest; and - Acute coronary syndromes occurring within the last 6 months prior to the first dose of study drug, Acute coronary syndrome, congestive heart failure (NYHA Class =II), aortic coarctation, stroke, or other grade 3 or greater cardiovascular event within 6 months prior to first dose; Left ventricular ejection fraction (LVEF) 180 mmHg and/or diastolic blood pressure > 100 mmHg on medication); - Clinical hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg on medication). and/or diastolic blood pressure > 100 mmHg); (8) Severe infections, including but not limited to bacteremia and severe pneumonia requiring hospitalization, within 4 weeks prior to the first dose of study drug; and active infections with CTCAE >=grade 2 requiring systemic antibiotic therapy within 2 weeks prior to the first dose of study drug; (9) Those who have experienced clinically significant bleeding symptoms within 3 months prior to first study drug administration. Subjects with significant coughing up o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS ;Overall Survival, OS;Duration of response, DOR;Disease control rate, DCR;Laboratory indicators;Quality of life assessment;Security;Biomarker; | — |
Countries
China
Contacts
Public ContactRen He
the Affiliated Hospital of Qingdao University
Outcome results
None listed