pancreatic cancer
Conditions
Interventions
Study Group:Hepatic Artery Infusion Chemotherapy (HAIC)+Surufatinib+Tirelizumab
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of science and technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand and voluntarily sign the informed consent form for this study; 2. Age range of 18 to 75 years old; 3. Patients with pancreatic ductal adenocarcinoma (PDAC) diagnosed by histopathology and accompanied by liver metastasis (at least one measurable lesion); 4. Good physical condition: ECOG score is 0-1 points; 5. Previously received fluorouracil, oxaliplatin, and irinotecan; Gemcitabine and or albumin paclitaxel based chemotherapy scheme, that is, pancreatic cancer patients with liver metastasis after receiving standard first-line chemotherapy progress; 6. No major organ dysfunction, laboratory tests meet the basic requirements of chemotherapy, namely: a) Neutrophil count >= 1.5 × 109/L; b) Platelet count >= 90 × 109/L; c) HB>=90g/L; d) Serum AST and ALT<=1.5 times the upper limit of normal ULN (if there is liver metastasis, AST and ALT <= 5.0 times ULN); e) Total bilirubin <= 1.5 times ULN; f) Serum creatinine <= 1.5 times ULN; g) ECG Q-T interval <= 450ms; h) Normal serum electrolytes (sodium, potassium, chloride, and total calcium); 7. Women of childbearing age should agree to use contraceptive measures during the study period and within 3 months after the end of the study; Within 7 days prior to enrollment in the study, the serum or urine pregnancy test must be negative and the patient must be non lactating; Men should agree to use contraceptive measures during the study period and within 3 months after the end of the study period. 8. There were no other contraindications before treatment, and the patient voluntarily enrolled with good compliance and was able to cooperate with the trial observation
Exclusion criteria
Exclusion criteria: 1. Patients with acinar cell carcinoma, pancreatoblastoma, solid pseudopapillary tumor, and pancreatic neuroendocrine tumor; 2. Pregnant or lactating women; Women of childbearing age tested positive in the baseline pregnancy test; 3. Diagnose brain metastasis through CT/MR; 4. Have received anti-tumor treatment with Surufatinib; 5. Other malignant tumors (except basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ or breast cancer) in the past 5 years; 6. Uncontrollable pleural effusion, pericardial effusion, or ascites; Within the 12 months prior to admission, severe cardiovascular diseases such as symptomatic coronary heart disease, congestive heart failure >= Grade II, uncontrolled arrhythmia, and myocardial infarction have occurred; 8. Accompanied by gastrointestinal obstruction/bleeding, digestive dysfunction or malabsorption syndrome; 9. Concurrent serious uncontrolled concurrent infections or other serious uncontrolled comorbidities, moderate or severe kidney injury; 10. Allergic reactions to the drugs used in this study; 11. Use steroids or other systemic immunosuppressive therapy 14 days before admission; 12. Patients who received study drug treatment within 4 weeks prior to enrollment (participating in other clinical trials). 13. Active autoimmune diseases (including but not limited to uveitis, enteritis, hepatitis, pituitary inflammation, nephritis, vasculitis, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilators). Patients with hypothyroidism who only require hormone replacement therapy and those with skin diseases without systemic treatment (such as vitiligo, psoriasis, or hair loss) can choose. 14. History of primary immunodeficiency. 15. Immunosuppressive drugs shall be used within 4 weeks before the first dose of study treatment, excluding systemic glucocorticoids of local or physiological dose (i.e. prednisone of no more than 10mg/day or other glucocorticoids of equivalent dose), nasal spray, inhalation or other ways, or hormones used to prevent contrast allergy. 16. Receive attenuated live vaccine within 4 weeks before or during the first dose of study treatment. 17. Known active pulmonary tuberculosis. We have learned about the history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 19. HIV antibody positive, active hepatitis B or C (hepatitis B: HBsAg positive, HBV DNA>=2000 Copy number/ml; Hepatitis C: HCV antibody and HCV-RNA positive, requiring antiviral treatment; 20. Other factors that may affect subject safety or trial compliance, as determined by researchers. For example, serious illnesses (including mental illnesses) that require comprehensive treatment, severe laboratory abnormalities, or other family or social factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progress Free Survival (PFS);Overall Survival (OS);Adverse Effect (AE); | — |
Countries
China
Contacts
Public ContactFu Qiang
Tongji Hospital, Tongji Medical College, Huazhong University of science and technology
Outcome results
None listed