Pancreatic cancer
Conditions
Interventions
Metastatic pancreatic ductal adenocarcinoma without systemic treatment:First 6 cycles (4 weeks/cycle) :
TQB2868 injection: 300mg, IV, d1, 15, Q4W
First 6 cycles (4 weeks/cycle) :
TQB2868 injection: 300mg, IV, d1, 15, Q4W
Gemcitabine 1000mg/m2, IV, d1, 8, 15, Q4W
Albumin paclitaxel: 125mg/m2, IV, d1, 8, 15, Q4W
Anlotinib capsules: 10mg po, qd, 2 weeks off 1 week, continued.
Maintenance therapy (after 6 cycles) :
TQB2868 injection: 300mg, IV, d1, Q3W
Gemcitabine 1000mg/m2, IV, d1, 8, Q3W
Anlotinib capsules: 10mg po, qd, 2 weeks off 1 week, continued.
Duration of medication:
TQB2868 injection: up to 2 years
Gemcitabine until disease progression, intolerance or loss of clinical benefit
Albumin paclitaxel: 6 cycles
Anlotinib capsule: used until disease progression, intolerance, or loss of clinical benefit.
The sequence of administration was oral anlotinib, followed by infusion of TQB2868, albumin paclitaxel, and
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1 Subjects voluntarily joined this study and signed informed consent; 2 Age 18-75 years old (the time of signing the informed consent, including the cut-off value); 3 Pancreatic ductal adenocarcinoma confirmed by histopathology or cytology; 4 At least one metastatic lesion that can be evaluated according to RECIST 1.1 criteria; 5 Without any systemic anti-tumor treatment (including but not limited to chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.; If the disease progressed 6 months after the end of neoadjuvant or adjuvant therapy); 6 ECOG score 0-1, estimated survival time more than 3 months; 7 Major organs function well and meet the following criteria: 1) Blood routine test criteria (no blood transfusion and no correction with hematopoietic stimulating factor drugs within 7 days before the test) : a. hemoglobin (HGB) =100 g/L; b. Absolute neutrophil count (NEUT) =1.5×109/L; c. Platelet count (PLT) =100×109/L. 2) Biochemical tests should meet the following criteria: a. Total bilirubin (TBIL) =1.5 times the upper limit of normal value (ULN) (biliary stent, PTCD and other drainage are allowed); b. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5× ULN. If there was liver metastasis, ALT and AST=5 ×ULN; c. Serum creatinine (CR) =1.5×ULN or creatinine clearance (CCR) =60 ml/min. 3) Coagulation function should meet the following criteria: International normalized ratio (INR) =1.5×ULN (without previous anticoagulant therapy); 4) Thyroid function test should meet the following criteria: Thyroid stimulating hormone (TSH) = ULN; T3 and T4 levels should be examined if abnormal, and patients with normal T3 and T4 levels were eligible. 5) Echocardiography: left ventricular ejection fraction (LVEF) =50%. 8 Patients had to use reliable contraception during the study period and for 6 months after the end of the study period; A negative serum pregnancy/urine pregnancy test within 7 days prior to study enrollment, and must be a non-lactating subject.
Exclusion criteria
Exclusion criteria: 1 Comorbidities and medical history: 1) the subject has a history or concurrent history of other malignant tumors (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) within 5 years; Patients with other malignancies, but the following two conditions could be included: other malignancies treated by single surgery, achieving R0 resection and no recurrence or metastasis for 5 years; Cured cervical carcinoma in situ, skin basal cell carcinoma, nasopharyngeal carcinoma and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)]; 2) unresolved toxic effects higher than CTC AE grade 1 due to any previous treatment, excluding alopecia; 3) major surgical treatment, significant traumatic injury, or long-term unhealed wounds or fractures within 28 days before the first dose of medication; 4) patients with any bleeding or bleeding event =CTC AE grade 3 within 4 weeks before the first dose; 5) patients with a history of arterial/venous thrombotic events, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, or pulmonary embolism, within 6 months before the first dose; The use of low-molecular-weight heparin was allowed, and antiplatelet drugs were prohibited during the study. 6) a history of gastrointestinal bleeding such as active gastric or duodenal ulcer or perforation, persistent positive fecal occult blood test, or ulcerative colitis within 6 months before the first dose; Or other conditions deemed by the investigator to be likely to cause bleeding; 7) patients with HBV infection are unable to receive regular antiviral therapy; HCV infection (HCV Ab or HCV RNA positive) : judged by the investigator to be in an unstable state, or unable to receive regular antiviral treatment while requiring continued antiviral treatment in the study; 8) patients with a history of psychotropic drug abuse and unable to quit or with mental disorders; 9) symptomatic interstitial lung disease and conditions that may trigger drug-induced pulmonary toxicity or associated pneumonia; 10) subjects with any severe and/or uncontrolled illness, including: a. Poorly controlled blood pressure (systolic blood pressure =150mmHg or diastolic blood pressure =100 mmHg) b. Grade =2 myocardial ischemia or myocardial infarction and grade =2 congestive heart failure (New York Heart Association (NYHA) class); c. Arrhythmia: QTc =450ms(male), QTc =470ms(female), frequent premature ventricular contraction, significant sinus bradycardia and other conditions that are considered by the investigators and related departments to be at high risk of malignant arrhythmia, or other conditions that may cause malignant arrhythmia as judged by the investigators; d. active or uncontrolled severe infection (=CTC AE grade 2 infection); d. renal failure requiring hemodialysis or peritoneal dialysis; e. a history of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency disorders, or a history of organ transplantation; f. poorly controlled diabetes mellitus (fasting blood glucose (FBG) > 10mmol/L); g. Urinary protein =++ and confirmed 24-hour urinary protein > 1.0 g; h. patients with epilepsy requiring treatment; 2 Cancer-related symptoms and treatment: 1) Other pathological types confirmed by histological or cytological examination, such as acinar cell carcinoma, neuroendocrine carcinoma, pancreatoblastoma, etc. 2) Imaging (CT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR), duration of response (DOR), overall survival (OS), disease control rate (DCR);Incidence of adverse events: the occurrence of all adverse events (AE), serious adverse events (SAE), and treatment-related adverse events (TEAEs); | — |
Countries
China
Contacts
Public ContactXianjun Yu
Fudan University Shanghai Cancer Center
Outcome results
None listed