Nimotuzumab for EGFR-amplified Advanced Pan Solid Tumors

Inclusion Criteria:

1. Esophageal cancer, gastric cancer, pancreatic cancer, colorectal cancer (leftcolorectal cancer), head and neck cancer (including oral cancer, oropharyngeal cancer,hypopharyngeal cancer, laryngeal cancer, nasopharyngeal cancer, oropharyngeal cancermust be p16 negative: p16 ≥ 70% is positive), cervical cancer, local recurrence orwith distant metastasis. Patients with known EGFR amplification and standard treatmentdepletion or inability to tolerate standard treatment and disease progression. Allowpatients with stable symptoms of brain metastasis to be enrolled.
2. Age 18-80 years old, both male and female. Expected life>3 months.
3. According to the criteria for evaluating the efficacy of solid tumors (RECIST 1.1),there should be at least one measurable lesion that has not undergone local treatmentsuch as radiotherapy (lesions located within the previous radiotherapy area, ifconfirmed to have progressed and meet the RECIST 1.1 criteria, can also be selected astarget lesions).
4. It has been confirmed through NGS testing that EGFR amplification existssimultaneously (all cancer species).
5. ECOG: 0-2.
6. Expected survival time ≥ 12 weeks.
7. If the main organs function normally, they meet the following standards:

(1) Blood routine examination: a. HB ≥ 90g/L;b. ANC ≥ 1.5 × 10^9/L;c. PLT ≥ 80 × 10^9/L.

(2) Biochemical examination: a. ALB ≥ 30g/L;b. ALT and AST ≤ 2.5ULN. If there is livermetastasis, ALT and AST ≤ 5ULN; c. TBIL ≤ 1.5ULN; d. Plasma Cr ≤ 1.5ULN or creatinineclearance rate (CCr) ≥ 60ml/min. 8. Women of childbearing age should agree to use contraceptive measures (such asintrauterine devices, contraceptives, or condoms) during the study period and within 6months after the end of the study. Within 7 days prior to enrollment in the study, theserum or urine pregnancy test was negative and must be a non-lactating patient. Men shouldagree to patients who must use contraception during the study period and within 6 monthsafter the end of the study period. 9. The subjects voluntarily joined this study, signed an informed consent form, had goodcompliance, and cooperated with follow-up.

Exclusion criteria:

1. The patient has any active autoimmune disease or autoimmune disease (For example, butnot limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis,hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism. patientswith vitiligo. asthma that has completely relieved in childhood and does not requireany intervention in adulthood can be included. asthma that requires medicalintervention with bronchodilators cannot be included).
2. The patient is currently using systemic hormone therapy to achieve immunosuppressiveeffects (dosage>10mg/day of prednisone or other therapeutic hormones) and continues touse it within 2 weeks before enrollment.
3. Previously received treatment with EGFR monoclonal antibodies or EGFR tyrosine kinaseinhibitors.
4. Patients with any severe and/or uncontrollable diseases, including: Patients with poor blood pressure control (systolic blood pressure ≥ 150mm Hg ordiastolic blood pressure ≥ 100 mmHg). Suffering from grade I or above myocardialischemia or infarction, arrhythmia (including QT interval ≥ 480ms), and grade Icardiac dysfunction. Active or uncontrollable serious infections. Liver diseases suchas decompensated liver disease, active hepatitis B (HBV-DNA ≥ 10^4 copies/ml or 2000IU/ml) or hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higherthan the detection limit of the analytical method).
5. Patients whose imaging shows that the tumor has invaded important blood vessels or whohave been determined by the researchers to be highly likely to invade important bloodvessels and cause fatal massive bleeding during subsequent studies.
6. Pregnant or lactating women.
7. Patients with other malignant tumors within 5 years (excluding cured skin basal cellcarcinoma and cervical carcinoma in situ).
8. Patients who have a history of abuse of psychotropic substances and are unable to quitor have mental disorders.
9. Patients who have participated in clinical trials of other drugs within four weeks.
10. Researchers believe that it is not suitable for inclusion.