pancreatic cancer and biliary tract cancer
Conditions
Interventions
Case series:None
Sponsors
Peking University International Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Cohort A: Cholangiocarcinoma diagnosed by histology or cytology, with locally advanced unresectable, local recurrence or with distant metastasis; 2. Cohort B: Histologically or cytologically diagnosed pancreatic cancer, with locally advanced unresectable, local recurrence or with distant metastasis; 3. Aged 18 to 75 years, including 18 years old and 75 years old; 4. ECOG PS score 0-2; 5. Patients who are not suitable for surgery (defined as patients whose physical condition does not allow or refuses surgery for various reasons); 6. According to the RECIST version 1.1 evaluation criteria, there is at least one measurable lesion; 7. Suitable for gemcitabine-based chemotherapy, including gemcitabine alone or gemcitabine combined with nab-paclitaxel; 8. Expected survival time >= 3 months; 9. Hematological indicators are basically normal: white blood cell count >=4x109^/L; absolute neutrophil count >=1.5x10^9/L; platelets >=100x10^9/L; hemoglobin >=90 g/L; 10. Basically normal renal function: serum creatinine=60mL/min; 11. Liver function is basically normal: serum total bilirubin <=1.5xULN (if liver metastases, serum total bilirubin should be <=3.0xULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5xULN (<= 5.0xULN, if there is liver metastasis); 12. Sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1. Those who have received radiation therapy, chemotherapy, monoclonal antibody and oral EGFR-TKI therapy, anti-angiogenesis drugs, and immunosuppressants within half a year; 2. Participated in other interventional clinical trials within 30 days before screening; 3. History of other malignant tumors (except for cured cervical carcinoma in situ or skin basal cell carcinoma and other malignant tumors that have been cured for more than 5 years); 4. There are concurrent diseases that are poorly controlled (such as heart failure, diabetes, hypertension, thyroid disease, mental illness, etc.); 5. Known HIV infection or active viral hepatitis; 6. Are receiving chronic steroid therapy for more than 6 months (such as prednisone dose > 10 mg/day or equivalent dose); 7. Those who are allergic to the drugs or their components used in this program; 8. According to the criteria of Common Adverse Event Terms (NCI CTCAE V5.0), >= grade 2 peripheral nerve disease or hearing loss; 9. Pregnant (confirmed by blood or urine HCG test) or lactating women, or subjects of childbearing age are unwilling or unable to take effective contraceptive measures (both male and female subjects) until at least after the last trial treatment 6 months; 10. The researcher believes that it is not suitable to participate in this researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate;disease control rate;complete response rate;1-year overall survival rate;1-year disease free survival rate;1-year disease free survival rate; | — |
Countries
China
Contacts
Public ContactLiang Jun
Peking University International Hospital
Outcome results
None listed