Advanced solid tumor
Conditions
Interventions
advanced esophageal cancer:NA
advanced pancreatic cancer:NA
advanced head and neck tumors:NA
advanced RAS wild-type colorectal cancer :NA
Sponsors
Beijing Luhe Hospital,Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Cohort A: histologically or cytologically confirmed esophageal squamous cell carcinoma with locally advanced unresectable, local recurrence, or distant metastasis; 2) Cohort B: Histologically or cytologically confirmed pancreatic cancer with locally advanced unresectable, local recurrence, or distant metastasis; 3) Cohort C: histologically or cytologically confirmed head and neck tumors with locally advanced unresectable, local recurrence, or distant metastasis; 4) Cohort D: Histologically or cytologically confirmed RAS-wild-type advanced colorectal cancer with locally advanced unresectable, local recurrence, or distant metastasis; 5) Age 18-80, male or female; 6) Failure or intolerance of standard first-line and second-line treatment for the above cancer types; 7) The primary tumor can be evaluated; 8) Tumor tissue samples were tested positive for EGFR by immunohistochemistry or FISH (EGFR2+ or above); EGFR amplification may be indicated by genetic testing; 9)ECOG: 0 ~ 1; 10) Expected survival =12 weeks; 11) The function of major organs is normal, that is, the following criteria are met: (1) Routine blood test: HB=90g/L; ANC=1.5×109/L; PLT=80×109/L; (2) Biochemical examination: ALB=30g/L; ALT and AST=2.5ULN; In case of liver metastasis, ALT and AST=5ULN; TBIL=1.5ULN; Plasma Cr=1.5ULN or creatinine clearance (CCr)=60ml/min; 12) Women of reproductive age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and for six months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating; Men should consent to patients who must use contraception during the study period and for 6 months after the study period ends; 13) The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: Patients were excluded from this study if they had any of the following: 1) The patient has any active autoimmune disease or has an autoimmune disease; 2) The patient is on immunosuppressive or systemic hormone therapy for immunosuppressive purposes (dose > 10mg/ day prednisone or other isotherapeutic hormone) and continued use within 2 weeks prior to enrollment; 3) Patients who have received other EGFR mab, other PD-1 mab, or EGFR tyrosine kinase inhibitors in the past 4 weeks or participated in clinical trials of such drugs; 4) Patients with any severe and/or uncontrolled medical condition, including uncontrolled hypertension, severe cardiac insufficiency, severe liver insufficiency, kidney failure, or other conditions deemed inappropriate by the investigator to participate in this study; 5) Patients whose imaging shows that the tumor has invaded important blood vessels or whose tumor is judged to be highly likely to invade important blood vessels and cause fatal massive bleeding during the follow-up study; 6) Pregnant or lactating women; 7) Patients with a history of psychotropic drug abuse and unable to abstain or patients with mental disorders; 8) Patients who have participated in clinical trials of other drugs within 4 weeks; 9) Other situations deemed unsuitable for inclusion by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival(OS);Disease Control Rate(DCR);Time to Treatment Failure(TTF); | — |
Countries
China
Contacts
Public ContactYurong Cheng
Beijing Luhe Hospital,Capital Medical University
Outcome results
None listed