Pancreatic cancer
Conditions
Interventions
Experimental group:Targeted therapy + chemotherapy + carbon ion beam radiation therapy
Sponsors
Wuwei Tumor Hospital Heavy Ion Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. ECOG PS score 0-2; 3. Patients with pancreatic adenocarcinoma diagnosed by histopathology or cytology; 4. According to the RECIST version 1.1 evaluation criteria, there is at least one measurable lesion; 5. Suitable for one cycle of gemcitabine combined with nimotuzumab; 6. Expected survival time >= 3 months; 7. Hematological indexes 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 ; 8. The renal function is basically normal: serum creatinine=60mL/min; 9. 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 metastasis); 10. Sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1. Those who have received monoclonal antibody and oral EGFR-TKI therapy, anti-angiogenic drugs, and immunosuppressive drugs within half a year; 2. Uncontrollable cancerous pleural effusion, pericardial effusion or ascites that requires frequent drainage within 14 days before enrollment (confirmation by cytology of effusion is allowed), gastrointestinal bleeding, or those who are judged by the investigator to have a high risk of bleeding; 3. Participated in other interventional clinical trials within 30 days before screening; 4. Patients with distant metastases, including but not limited to lung metastases, bone metastases and brain metastases; 5. 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); 6. There are concurrent diseases that are poorly controlled (such as heart failure, diabetes, hypertension, thyroid disease, mental illness, etc.); 7. Known HIV infection or active viral hepatitis; 8. Are receiving chronic steroid therapy for more than 6 months (such as prednisone dose > 10 mg/day or equivalent dose); 9. According to the criteria of Common Adverse Event Terms (NCI CTCAE V5.0), >= grade 2 peripheral nerve disease or hearing loss; 10. Pregnancy (confirmed by blood or urine HCG test) or lactating patients, or patients of childbearing age are unwilling or unable to take effective contraceptive measures (both male and female patients) until at least 6 months after the last trial treatment; 11. The researcher believes that it is not suitable to participate in the researcher; 12. Unwilling to participate in this research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year overall survival (OS) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective tumor response rate (ORR);Median overall survival (OS);Median progression-free survival (PFS);1 - year progression-free survival (PFS) rate;Quality of life (QOL); | — |
Countries
China
Contacts
Public ContactZhang Yanshan
Wuwei Tumor Hospital Heavy Ion Center
Outcome results
None listed