pancreatic cancer
Conditions
Interventions
Experimental group:Donafenib, Teggio
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily join the group and sign written informed consent; 2. Aged 18 to 75 years, gender is not limited; 3. Advanced metastatic pancreatic cancer (derived from pancreatic ductal epithelium) confirmed by histology or cytology; 4. Failure of first-line treatment with albumin-bound paclitaxel combined with gemcitabine (NG regimen) (disease progression during or within 6 months after treatment, with clear imaging evidence; excluding patients with intolerable toxicity); 5. According to the Response Evaluation Criteria for Solid Tumors (RECIST version 1.1), there is at least one lesion that can be measured by imaging; 6. ECOG score 0-1 points; 7. Expected survival time > 3 months.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with other malignant diseases other than pancreatic cancer within 5 years before the first administration (excluding basal cell carcinoma of the skin and squamous epithelial carcinoma of the skin and/or carcinoma in situ after radical resection) 2. Suffering from diseases that affect the absorption, distribution, metabolism or clearance of the study drug (such as severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorder, etc.); 3. Known presence of brain metastases or leptomeningeal metastases; 4. There is a clear history of neurological or psychiatric disorders including epilepsy or dementia; 5. According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study (such as severe or uncontrollable hypertension, severe diabetes and/or thyroid disease, etc.); 6. Currently participating in interventional clinical research treatment or receiving other research drugs or using research devices within 4 weeks before the first dose; 7. There is a history of organ transplantation in the past; 8. Concomitant use of drugs that may prolong QTc and/or induce torsades de pointes (Tdp) or drugs that affect drug metabolism; 9. Allergy to any study drug; 10. HIV-infected patients or patients with acute and chronic viral hepatitis (positive for hepatitis B surface antigen and HBV-DNA load >= 500IU/ml and/or positive for hepatitis C virus antibody).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;progression free survival;time to progression; | — |
Countries
China
Contacts
Public ContactYu Xianjun
Fudan University Shanghai Cancer Center
Outcome results
None listed