Advanced tumor
Conditions
Interventions
Advanced esophageal cancer:PD-1 monoclonal antibody+nimotuzumab
Advanced pancretic cancer:PD-1 monoclonal antibody+nimotuzumab
Advanced head and neck tumor:PD-1 monoclonal antibody+nimotuzumab
RAS-WT-Advanced colorectal cancer:PD-1 monoclonal antibody+nimotuzumab
Sponsors
Beijing luhe hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Cohort A: esophageal squamous cell carcinoma confirmed histologically or cytologically, locally advanced unresectable, locally recurrent or with distant metastasis; 2. Cohort B: histologically or cytologically confirmed pancreatic cancer with locally advanced unresectable, local recurrence or distant metastasis; 3. Cohort C: head and neck tumors confirmed by histology or cytology with locally advanced unresectable, local recurrence or distant metastasis; 4. Cohort D: Ras-wild-type advanced colorectal cancer, histologically or cytologically confirmed, locally advanced unresectable, locally recurrent, or with distant metastasis; 5. Age 18-80, male or female; 6. Failure or intolerance to standard first-line and second-line therapies for the above cancers; 7. Primary tumor can be evaluated(based RECIST1.1); 8. EGFR positive by immunohistochemical test or FISH test (EGFR2+ or above); 9.ECOG: 0 ~ 1; 10. Expected survival =12 weeks; 11. Normal functioning of major organs means meeting the following criteria: (1) Routine blood test: A.Hemoglobin >90 g/L B.Neutrophile count > 1.5 x 109 / L; C.PLT >80 x 109 / L; (2) Biochemical examination: A.ALB >30 g/L; B.ALT and AST =2.5ULN; ALT and AST=5ULN if liver metastasis was present; C.TBIL <1.5ULN 1.5; D. SCr=1.5ULN or eGFR=60ml/min; 12. Lung function: FEV1/FVC=70%, FEV1=50% normal value, 13. Subjects who may become pregnant need contraception during the study; 14. Subjects voluntarily joined the study and signed informed consent with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. The patient has any active autoimmune disease or has autoimmune disease; 2. The patient is on immunosuppressant, or systemic hormone therapy for immunosuppression purposes and continued to use within 2 weeks prior to enrollment; 3. Prior treatment with other EGFR mab, other PD-1 mab, EGFR tyrosine kinase inhibitor; 4. Patients with any severe and/or uncontrolled disease, including uncontrolled hypertension, severe cardiac insufficiency, severe liver insufficiency, renal failure, or other conditions considered inappropriate for the study by the investigator; 5. Patients whose imaging shows that the tumor has invaded the perivascular area of important blood vessels or whose tumor is highly likely to invade important blood vessels and cause fatal massive bleeding as determined by the investigator during the follow-up study; 6. Pregnant or lactating women; 7. Those who have a history of psychotropic drug abuse and cannot get rid of it or those with mental disorders; 8.Patients who have participated in other clinical trials in last 4 weeks 9.The others inappropriate to participate in the study judged by reasearcher
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 year-progression free survival rate,1-year-PFS rate;1 year overall survival rate, 1 year OSrate;2 years progression free survival rate, 2-years-PFS rate;2 years overall survival rate, 2 years OS rate;median overall survival,mOS;median progression free survival,mPFS;Disease control rate,DCR; | — |
Countries
China
Contacts
Public ContactYan Dong
Beijing luhe hospital
Outcome results
None listed