pancreatic cancer
Conditions
Interventions
Nituzumab combined chemotherapy group:No
Sponsors
Baotou Tumor Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, including 18 years old and 75 years old; 2. ECOG PS score 0-2; 3. Patients with stage III-IV pancreatic cancer diagnosed by histopathology or cytology. If the patient refuses to puncture or the pancreatic pathological puncture is difficult, PET-CT, nuclear magnetic resonance, tumor markers (CA199, CA125, CEA) and other relevant evidence are required to support. (According to the 2020 CSCO Guidelines for the Diagnosis and Treatment of Pancreatic Tumors). 4. Histopathological immunohistochemistry or blood gene test showed positive EGFR expression 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 receiving chemotherapy treatment for the purpose of radical cure. 8. Expected survival time >= 3 months; 9. Hematological indicators are basically normal: white blood cell count >=4x10^9/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) <=2.5x ULN (<=5.0xULN, if there is liver metastases). 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. Patients with distant metastasis; 4. 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); 5. There are concurrent diseases that are poorly controlled (such as heart failure, diabetes, hypertension, thyroid disease, mental illness, etc.); 6. Known HIV infection or active viral hepatitis; 7. Are receiving chronic steroid therapy for more than 6 months (such as prednisone dose > 10 mg/day or equivalent); 8. Those who are allergic to the drugs or their components used in this program; 9. According to the criteria of Common Adverse Event Terms (NCI CTCAE V5.0), >= grade 2 peripheral nerve disease or hearing loss; 10. 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; 11. The researcher believes that it is not suitable to participate in this researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 year progression-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective tumor response rate ;Tumor complete remission rate;Disease control rate ;1-year overall survival;1 year local control rate;Median overall survival ;Median progression free survival ; | — |
Countries
China
Contacts
Public ContactTan Yaqin
Baotou Tumor Hospital
Outcome results
None listed