Pancreatic cancer
Conditions
Interventions
Experimental group:AG regimen + Nimotuzumab
Control group:AG regimen + Placebo
Sponsors
Peking University Cancer Hospital & Institute
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18 to 75 years old (including both 18 and 75 years old), gender not limited. 2. Confirmed as pancreatic adenocarcinoma by histopathology or cytology; 3. Confirmed as resectable or borderline resectable pancreatic cancer by CT/MRI imaging examination (resectability assessment refers to NCCN standards), if it is resectable pancreatic cancer, any of the following high-risk factors must also be met: CA199>500 U/ml (If there is biliary obstruction, it is the value after biliary decompression) The maximum diameter of the primary tumor is greater than 3.0 cm Severe emaciation (BMI15% within 6 months) Extreme pain (NRS>=4) Clear regional lymph node metastasis (N1 or N2) or suspected regional lymph node enlargement with metastasis (short diameter of lymph nodes >=15mm) 4. Voluntarily accept sample collection (for KRAS gene testing and post-event analysis); 5. Sufficient bone marrow hematopoietic function reserve and organ function: hemoglobin >= 9.0g /dL; Neutrophil count >=1.5×10^9/L; Platelet count >=80×10^9/L; Total bilirubin (TBIL) 60 mL/min(using the Cockcroft-Gault formula) : For females, CrCl=(140- age)× weight (kg)× 0.85 / (72×Scr mg/dl); for males, CrCl=(140- age)× weight (kg)× 1.00 / (72×Scr mg/dl). 6. ECOG PS score 0-2; 7. Expected survival period: >=3 months; 8. Women with potential fertility who have negative serum or urine HCG within 72 hours before randomization (postmenopausal women who have been amenorrhea for at least 12 months are considered infertile, and women who are known to have undergone tubal ligation are not required to undergo pregnancy tests); 9. Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Previous treatment for pancreatic cancer. 2. Accompanied by other serious diseases, including but not limited to: active infections; unmanageable diabetes mellitus and uncontrolled hypertension (SBP>160mmHg or DBP>100mmHg); compensatory heart failure (NYHA grade III and IV), unstable angina or poorly controlled arrhythmias within 3 months prior to randomization; presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage; severe portal hypertension; digestive tract obstruction; respiratory insufficiency and severe lung disease; central nervous system disease or mental illness; 3. Clinically diagnosed as local recurrence of pancreatic cancer, or there is evidence of peritoneal/other distant metastases; 4.History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); 5. Presence of bleeding or coagulation disorders; 6. Known allergy to prescription or any component of the prescription used in this study; 7. Known HIV infection, syphilis infection, or active hepatitis (hepatitis B or C); 8. Women who are pregnant or are breastfeeding; 9.Other reasons that are not suitable to participate in this study according to the researcher's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival (DFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);R0 resection rate;Surgical Resection rate;Objective response rate (ORR);Adverse events; | — |
Countries
China
Contacts
Public ContactChunyi Hao
Peking University Cancer Hospital & Institute
Outcome results
None listed