pancreatic cancer
Conditions
Interventions
Single queue:nituzumab combined with gemcitabine and albumin paclitaxel
Sponsors
Shenzhen Second People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Subjects voluntarily join the study and sign the informed consent. (2) Aged 18-75 years, including 18 years and 75 years; (3) ECOG score 0-1; (4) Patients with stage III-IV pancreatic cancer confirmed by histopathology or cytology. If the patient refuses puncture or the pancreas is pathologically difficult to puncture, relevant evidence such as PET-CT, NMR, and tumor markers (CA199, CA125, CEA) should be provided. (According to the 2022 CSCO Pancreatic Cancer Guidelines). (5) Patients with locally advanced or metastatic pancreatic cancer without systematic chemotherapy. 9 (6) Patients who are not suitable for surgery (defined as patients whose physical conditions do not allow surgery or refuse surgery for various reasons); (7) Have at least one measurable lesion according to RECIST version 1.1 evaluation criteria; (8) Suitable for chemotherapy with the purpose of radical treatment. (9) Expected survival time = 3 months; (10) Hematological indexes were basically normal: white blood cell count =4×109/L; Absolute neutrophil count =1.5×109/L; Platelet =100×109/L; Hemoglobin =90 g/L; (11) Basically normal renal function: serum creatinine =1.2mg/dL or creatinine clearance =60mL/min (12) Basically normal liver function: serum total bilirubin =1.5×ULN (if there is liver metastasis, serum total bilirubin =3.0×ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5×ULN (=5.0×ULN if liver metastases are present).
Exclusion criteria
Exclusion criteria: (1) Have participated in other interventional clinical trials within 30 days prior to screening; (2) Have other uncured malignant tumors; (3) There are poorly controlled concurrent diseases (such as heart failure, diabetes, hypertension, thyroid disease, mental illness, etc.); (4) Known HIV infection or active viral hepatitis; (5) is receiving chronic steroid hormone therapy for more than 6 months (eg, prednisone dose> 10 mg/day or equivalent); (6) Those who are allergic to the drugs used in this program or their components; (7) grade =2 peripheral neurological disease or hearing loss according to the criteria of common adverse event terminology (NCI CTCAE V5.0); (8) pregnant (confirmed by menstrual blood or urine HCG testing) or lactating women, or subjects of childbearing age who are unwilling or unable to use effective contraception (both male and female subjects) until at least 6 months after the last trial treatment; (9) Those who the investigator deems unsuitable to participate in the study; (10) Those who do not wish to participate in the study or are unable to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, ORR;progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical benefit rate;duration of remission;overall survival ; | — |
Countries
China
Contacts
Public ContactLin Lin
Shenzhen Second People's Hospital
Outcome results
None listed