advanced pancreatic ductal adenocarcinoma
Conditions
Interventions
Experimental group:Imatinib combined with albumin paclitaxel, gemcitabine
Sponsors
The First Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients who meet the following criteria will be included in this study and will use imatinib in combination with albumin paclitaxel, gemcitabine regimen: 1. Age 18-80 years old, male or female; 2. Patients with untreated pancreatic ductal adenocarcinoma (PDAC) confirmed by pathological examination; or untreated recurrent pancreatic ductal adenocarcinoma (surgery, adjuvant/neoadjuvant chemotherapy was allowed in the past, and it was =3 months after the end of adjuvant chemotherapy at the time of recurrence, and the adjuvant/neoadjuvant chemotherapy regimen did not include imatinib, gemcitabine, and nab-paclitaxel); 3. Physical condition ECOG PS score: 0-1 points; 4. Estimated survival = 3 months; 5. At least 1 measurable target lesion that can be examined by CT or MRI according to RECIST 1.1 criteria; 6. The laboratory examination indicators meet the following requirements: (1) Bone marrow function: hemoglobin (Hb) =90g/L; White blood cell count (WBC) = lower limit of normal; Absolute neutrophil value (ANC) =1.5×10^9 /L; Platelet count = 100×10^9/L; (2) Renal function: Cr=UNL (upper limit of normal) ×1.5, endogenous creatinine clearance (Ccr) =55 ml/min; (3) Liver function: total bilirubin =ULN×1.5;ALT and AST=ULN×2.5;(if there is liver metastasis, total bilirubin is not higher than 3 times the upper limit of normal, and transaminases are not higher than 5 times the upper limit of normal); (4) Coagulation function: the international normalized ratio of prothrombin time =ULN×1.5, and some thromboplastin time was within the normal range; 7. Have not received any prior anti-tumor therapy for advanced PDAC, including chemotherapy, radiotherapy, targeted, hormonal or immunological therapy; Patients after R2 resection are allowed to enroll; 8. Females of childbearing potential agree to use contraception during the study and for 6 months after the end of the study; Patients with a negative serum or urine pregnancy test within seven days prior to study enrollment and who are not lactating; Patients whose males agree to use contraception during the study and for 6 months after the end of the study; 9. Those who have not participated in other drug clinical trials within 4 weeks before enrollment; 10. Subjects can understand the situation of this study and voluntarily sign the informed consent form. 11. No serious complications such as active gastrointestinal bleeding, perforation, jaundice, gastrointestinal obstruction, non-cancerous fever >38°C; 12. It is expected that those with good compliance can follow up the efficacy and adverse reactions according to the requirements of the protocol.
Exclusion criteria
Exclusion criteria: Patients with any of the following are not included in the data collected in this study: 1. Other malignant tumors have been diagnosed within the past 5 years, especially chronic myeloid leukemia and gastrointestinal stromal tumors (except carcinoma in situ, basal cell carcinoma, etc.); 2. Known central nervous system metastases (except for those with stable disease control and asymptomatic after 4 weeks of radiotherapy or surgery) or evidence of carcinomatous meningitis; 3. Those who suffer from mental or neurological diseases and are unable to cooperate; 4. Patients who have previously received the drug regimen of this study (imatinib, albumin paclitaxel, gemcitabine); 5. Patients who are ready to undergo or have previously received organ or bone marrow transplantation; 6. Has any active autoimmune disease or history of autoimmune disease; 7. Vaccination with a live vaccine within 30 days prior to the first dose (injectable seasonal influenza vaccine is allowed as the vaccine is an inactivated vaccine); 8. Have uncontrolled cardiac clinical symptoms or diseases; 9. Have active infection or fever (except for definite tumor fever); 10. History or evidence of interstitial lung disease or active non-infectious pneumonitis; 11. Those with other diseases who are not suitable for enrollment, such as immunodeficiency, active tuberculosis, hepatitis B (hepatitis B virus titer HBV-DNA 10mg/day prednisone efficacy dose; 14. Those who have received radiotherapy, chemotherapy, targeted therapy or immunotherapy within 4 weeks before enrollment; 15. Pregnant or lactating women; 16. Those who are considered unsuitable for enrollment by the investigator.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Disease control rate;Overall survival; | — |
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Countries
China
Contacts
Public ContactXiaoyu Yin
The First Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed