An Open ,Single Arm, Prospective and Basket Clinical Study of Nimotuzumab in the Treatment of EGFR-amplified Advanced Pan Solid Tumors (Lung/Esophageal/Gastric/Pancreatic /Colorectal / Head and Neck Cervical)
Nimotuzumab
Treatment Study
Summary
Study start date: December 1, 2022
Actual date on which the first participant was enrolled.This study aims to evaluate the effectiveness and safety of a drug called Nimotuzumab for treating advanced solid tumors that have a specific genetic characteristic known as EGFR amplification. These tumors can occur in various organs such as the lung, esophagus, stomach, pancreas, colon, and head and neck areas. The study focuses on patients who have these EGFR-amplified tumors confirmed through specialized genetic testing methods. It is important because understanding how Nimotuzumab works in real-world conditions might lead to better treatment options for patients facing these challenging cancers, potentially improving their outcomes. Participants in the study will receive Nimotuzumab as a treatment, and their response to the drug will be closely monitored. The drug's effects will be studied using various tests to see how well it works against the tumors. Additionally, the study will investigate molecular markers that might predict how effective the treatment will be for each participant. The study will also consider the patient's medical history, current health, and other factors to determine the best combination of treatments, if necessary. By analyzing these aspects, the study aims to find the most suitable treatment strategy for each individual, while assessing any potential benefits or risks related to Nimotuzumab.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.46 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: 1. Esophageal cancer, gastric cancer, pancreatic cancer, colorectal cancer (left colorectal cancer), head and neck cancer (including oral cancer, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer, nasopharyngeal cancer, oropharyngeal cancer must be p16 negative: p16 ≥ 70% is positive), cervical cancer, local recurrence or with distant metastasis. Patients with known EGFR amplification and standard treatment depletion or inability to tolerate standard treatment and disease progression. Allow patients 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 treatment such as radiotherapy (lesions located within the previous radiotherapy area, if confirmed to have progressed and meet the RECIST 1.1 criteria, can also be selected as target lesions). 4. It has been confirmed through NGS testing that EGFR amplification exists simultaneously (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 liver metastasis, ALT and AST ≤ 5ULN; c. TBIL ≤ 1.5ULN; d. Plasma Cr ≤ 1.5ULN or creatinine clearance rate (CCr) ≥ 60ml/min. 8\. Women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study period and within 6 months after the end of the study. Within 7 days prior to enrollment in the study, the serum or urine pregnancy test was negative and must be a non-lactating patient. Men should agree to patients who must use contraception during the study period and within 6 months after the end of the study period. 9\. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up. Exclusion criteria: 1. The patient has any active autoimmune disease or autoimmune disease (For example, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism. patients with vitiligo. asthma that has completely relieved in childhood and does not require any intervention in adulthood can be included. asthma that requires medical intervention with bronchodilators cannot be included). 2. The patient is currently using systemic hormone therapy to achieve immunosuppressive effects (dosage\>10mg/day of prednisone or other therapeutic hormones) and continues to use it within 2 weeks before enrollment. 3. Previously received treatment with EGFR monoclonal antibodies or EGFR tyrosine kinase inhibitors. 4. Patients with any severe and/or uncontrollable diseases, including: Patients with poor blood pressure control (systolic blood pressure ≥ 150mm Hg or diastolic blood pressure ≥ 100 mmHg). Suffering from grade I or above myocardial ischemia or infarction, arrhythmia (including QT interval ≥ 480ms), and grade I cardiac dysfunction. Active or uncontrollable serious infections. Liver diseases such as 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 higher than the detection limit of the analytical method). 5. Patients whose imaging shows that the tumor has invaded important blood vessels or who have been determined by the researchers to be highly likely to invade important blood vessels 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 cell carcinoma and cervical carcinoma in situ). 8. Patients who have a history of abuse of psychotropic substances and are unable to quit or 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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Tianjin Medical University Second Hospital
Tianjin, ChinaOpen Tianjin Medical University Second Hospital in Google Maps