advanced pancreatic cancer
Conditions
Interventions
single group:Surufatinib plus Envafolimab plus Tegafur-Gimeracil-Oteracil Potassium Capsule
Sponsors
Fujian Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with advanced pancreatic cancer confirmed by pathology or clinical diagnosis; 2. Aged 18-75 years (including 18 and 75 years old); 3. Target lesions can be measured; 4. Progression after standard first-line chemotherapy; 5. Eastern Cooperation Oncology Group (ECOG) quality of life performance status of 0-2; 6. Life expectancy >= 3 months; 7. Women of childbearing age need to have a negative pregnancy test; 8. There are no contraindications to chemotherapy for basic examinations such as electrocardiogram, blood, and biochemistry; 9. Patients who are known to MSI-H but cannot tolerate or cannot afford the costs associated with immunotherapy, and are willing to enroll after fully informed.
Exclusion criteria
Exclusion criteria: 1. There is no reliable contraceptive measure during childbearing; 2. Any disease or state affecting drug absorption, or the patient cannot take oral medication; 3. Known allergy to any surufatinib, envafolimab or tegafur-gimeracil-oteracil, or history of severe allergy to any other monoclonal antibody; 4. Previous treatment with any anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody or any other antibody acting on T cell synergistic stimulation or checkpoint pathway (such as OX40, CD137, etc.); 5. Previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors and have developed disease progression during or within 4 months after the last dose; 6. Known allergy to any tripriplimab, surufatinib, tegafur-gimeracil-oteracil, or history of severe allergy to any other monoclonal antibody; 7. Have received Immunosuppressants within 4 weeks before the first dose, excluding topical glucocorticoid hormones or physiological doses of systemic glucocorticoids (i.e., not more than 10 mg/day prednisone or equivalent doses of other glucocorticoids), allowing the temporary use of glucocorticoids due to respiratory difficulties such as asthma and chronic obstructive pulmonary disease; 8. Any active autoimmune disease that requires systematic treatment or a history of autoimmune diseases within the past 2 years, including but not limited to interstitial pneumonia, uveitis, inflammatory intestinal disease, hepatitis, pititis, vasculitis, systemic lupus erythematosus, etc. (vitiligo, psoriasis, hair loss or Grave's disease that do not require systematic treatment in the past 2 years and patients with type I diabetes who only need insulin replacement therapy can be included); known history of primary immunodeficiency; patients with positive autoimmune antibodies need to be judged by the investigator to confirm the presence of autoimmune diseases; 9. Patients with active infections; 10. Have contraindications to chemotherapy in combination with other chronic diseases; 11. Any other reasons that makes the patient not suitable for enrolling this study according to the judgment of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate;Overall Survival;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactLiu Zhenhua
Fujian Provincial Hospital
Outcome results
None listed