UnresectableLocally Advanced or Metastatic Pancreatic Cancer
Conditions
Interventions
experimental group:nab-paclitaxel at 125 mg/m2 on days 1 and 8, gemcitabine at 1000 mg/m2 on days 1 and 8, KN046 at 5 mg/kg on day 1, plus surufatinib per cohort escalation assignment starting with 20
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed informed content obtained prior to treatment; 2. Male or female, age >= 18 years and = 6 months; 8. Laboratory test results within 7 days prior to first dose of study drugs must meet the following criteria: (1) Absolute neutrophil count (ANC) >= 1.5 × 109/L, platelet count (PLT) >= 100 x 10^9/L and hemoglobin (HGB) >= 90 g/L; (2) Total bilirubin (TBil) = 50 mL/min (calculated according to the Cockcroft-Gault formula); (5) Urine protein = 2+, 24-hour urine protein quantification should be < 1 g; (6) International normalized ratio (INR) <= 1.5 and partial activation prothrombin time (APTT) <= 1.5 x ULN; 9. Female subjects of childbearing age or male subjects whose partner is a female of childbearing age should use effective contraception from at least 1 month prior to the first dose of study drugs to 6 months after the last dose of study drugs.
Exclusion criteria
Exclusion criteria: 1. Adverse events (AEs) due to previous anti-tumor therapy have not recovered to CTCAE Grade 25% bone marrow) within 4 weeks prior to the first study drugs reception; Or brachytherapy (e.g., implanted radioparticles) within 60 days prior to the first dose of the study drugs; Or palliative radiotherapy for bone metastases within 1 week prior to first dose of the study drugs; 6. Patients who have undergone major surgery within 4 weeks before receiving first dose of study drugs, or have unhealed wounds, ulcers or fractures; 7. Vaccination within 4 weeks before the first dose of study drugs or plan to have during the study period, except for inactivated vaccines; 8. Patients who have previously received anti-VEGF/VEGFR agents and have experienced disease progression during treatment or within 3 months after the last dose; 9. Patients with uncontrollable malignant pleural effusion, ascites, or pericardial effusion (no response to diuretics or puncture as per the investigator's judgement); 10. Presence of gastrointestinal diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding in unresected tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by the investigator; 11. Patients with evidence or history of thrombosis or significant bleeding tendency (bleeding > 30 mL within 2 months, hematemesis, melena, hematochezia, or hemoptysis > 5mL within 4 weeks) within 2 months prior to the first dose of the study drugs; 12. Patients who have arterial thrombosis or deep vein thrombosis within 6 months, or have thromboembolic events (including stroke and/or transient ischaemic attack) within 12 months prior to first dose of the study drugs; 13. Patients who are receiving anti-tuberculosis therapy for active pulmonary tuberculosis, or have had anti-tuberculosis therapy within 1 year prior to first dose of the study drugs; 14. Patients with a previous or current history of pulmonary disorder that may interfere the identification and management of suspected drug-related pulmonary toxicity, including pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc. (radiation pneumonia in radiotherapy areas is allowed); 15. Presence of corneal lesions, including but not limited to bullous keratopathy, shingle corneal degeneration, corneal abrasions, corneal ulcers, keratitis, etc.; 16. History of clinically significant hepatic disease, including, but not limited to, known hepatitis B virus (HBV) infection with HBV DNA positive; known Hepatitis C virus (HCV) infection with HCV RNA positive; or other hepatitis, liver cirrhosis, etc.; 17. Positive for human
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (RECIST 1.1);Predictive biomarkers; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (irRECIST) ;Disease control rate;Progression free survival (RECIST 1.1);Overall survival ;Safety and tolerability by incidence, severity and outcome of adverse events; | — |
Countries
China
Contacts
Public ContactLiang Liu
Zhongshan Hospital, Fudan University
Outcome results
None listed