Biliary tract/pancreatic cancer
Conditions
Interventions
1pancreatic:Sofantinib + Cardunculizumab + Umami Soup
1biliary tract cancer:Sofantinib + Cardunculizumab + Umami Soup
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Biliary tract cancer inclusion criteria: (1) Adenocarcinoma of the gallbladder or adenocarcinoma of the bile duct confirmed by pathologic histology or cytology; signed informed consent; (2) Imaging-confirmed stage IV biliary tract cancer (AJCC TNM staging); (3) Age 18-80 years old male or female; (4) Liver function Child-Pugh grade A (5-6 points) or better grade B (=7 points) (5) Have measurable target lesions; (6) Progression after first-line treatment; (7) Quality of life score of 0-3 according to the Eastern Cooperative Oncology Group (ECOG); (8) Expected survival >3 months; (9) No contraindication to treatment by basic tests such as electrocardiogram blood biochemistry cardiac enzyme profile thyroid function etc; (10) Female patients of childbearing age should have negative pregnancy test. Inclusion criteria for pancreatic cancer: (1) Patients with pancreatic adenocarcinoma confirmed by pathology or clinical diagnosis signing the informed consent; (2) Stage IV pancreatic cancer (AJCC TNM stage) confirmed by imaging; (3) Age 18-80 years old male or female; (4) Have measurable target lesions; (5) Progression after first-line treatment; (6) Quality of life score of 0 to 3 according to the Eastern Cooperative Oncology Group (ECOG); (7) Expected survival >3 months; (8) No contraindications to treatment on basic tests such as electrocardiogram blood biochemistry cardiac enzyme profile and thyroid function; (9) Female patients of childbearing age need to have a negative pregnancy test.
Exclusion criteria
Exclusion criteria: Biliary tract cancer exclusion criteria: (1) Prior treatment with any anti-PD-L1 antibody and/or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody; (2) Patients who have received prior treatment with anti-VEGF/VEGFR/FGFR-targeted agents and have experienced disease progression during or within 4 months of the last dose; (3) Use of immunosuppressive agents excluding topical glucocorticoid hormones by nasal spray inhalation or other routes or physiologic doses of systemic glucocorticosteroids (i.e. no more than 10 mg/day of prednisone or equivalent dose of other glucocorticosteroids) within 4 weeks prior to the first dose of the medication with temporary use of glucocorticosteroids permitted due to respiratory distress for the treatment of asthma COPD and other reasons; (4) Presence of any active autoimmune disease requiring systemic treatment or a history of autoimmune disease within the previous 2 years including but not limited to interstitial pneumonitis uveitis inflammatory bowel disease pituitary gland inflammation vasculitis and systemic lupus erythematosus (vitiligo psoriasis alopecia areata or Grave's disease that did not require systemic treatment in the last 2 years and patients with type I diabetes who require only insulin replacement therapy may be included); known history of primary immunodeficiency; patients with only positive autoimmune antibodies need to confirm the presence of autoimmune disease according to the investigator's judgment (5) Patients with the presence of active infections (6) Multiple primary tumors or contraindications to treatment such as the combination of other chronic diseases. (7) Patients with central nervous system metastases. -Previously treated with systemic radical brain or meningeal metastases (radiotherapy or surgery) may be included if imaging confirms that stabilization has been maintained for at least 1 month and systemic hormone therapy (dose >10mg/day prednisone or other isotonic hormones) has been discontinued for >2 weeks without clinical evidence. (8) Patients with current medically uncontrolled hypertension defined as systolic blood pressure =160 mmHg and/or diastolic blood pressure =90 mmHg; (9) Those with urine routine suggesting urinary protein =2+ and a 24-hour urine protein volume >1.0 g; (10) Patients with evidence or history of significant bleeding tendency within 3 months prior to enrollment (hemorrhage >30 mL within 3 months vomiting blood black stool blood in stool) hemoptysis (>5 mL of fresh blood within 4 weeks) or thromboembolic events (including stroke events and/or transient ischemic attacks) within 12 months; (11) Clinically significant cardiovascular disease including but not limited to acute myocardial infarction severe/unstable angina pectoris or coronary artery bypass grafting within 6 months prior to enrollment; congestive heart failure New York Heart Association (NYHA) classification >2; ventricular arrhythmia requiring medication; and electrocardiogram (ECG) showing a QTc interval of =480 milliseconds ; (12) No reliable contraception during childbearing years; (13) Any current disease or condition that interferes with drug absorption or the patient is unable to administer the drug orally; (14) Known hypersensitivity to the clinical trial drug or prior history of severe allergy to any other monoclonal antibody; (15) Patients who in the opinion of the investigator have other reasons for being unsuitable for participation in this cl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR2w;DCR2w; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability; | — |
Countries
China
Contacts
Public ContactLi ping
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed