Lung cancer
Conditions
Interventions
Phase I research stage:Dose A: Bevatinib should be taken starting from a dosage of 75 mg for 21 consecutive days
If there are no serious side effects or grade = 2 thrombocytopenia and/or grade = 2 headache, the dose will be adjusted to 100 mg (once daily) and 100 mg of Frucoxib (once daily) after 21 days
Dose B
If there are no serious side effects or grade = 2 thrombocytopenia and/or grade = 2 headache, the dose will be adjusted to 100 mg (once daily) and 200mg of Frucoxib (once daily) after 21 days
Phase I
Sponsors
Zhejiang cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age: 18-75 years old (including 18 and 75 years old); (2) Clinically diagnosed with non-small cell lung cancer through histopathology, and confirmed by tissue or blood genetic testing to carry EGFR gene exon 19 and/or 21 sensitive mutations; Patients with mixed non-small cell lung cancer histological characteristics (squamous and non squamous) or unspecified non-small cell lung cancer can be included in the study; (3) According to the AJCC 8th edition staging system, the clinical staging is II-IIIB stage, and all lesions have been evaluated as surgically resectable; (4) ECOG behavioral status score of 0-1, expected survival time>1 year; (5) The functional levels of important organs such as the heart, lungs, liver, and kidneys meet the requirements for drug research and anesthesia surgery. (6) Women of childbearing age must undergo a pregnancy test with a negative result within 7 days before starting treatment, and take contraceptive measures during and within 3 months after treatment; Male of childbearing age: Take contraceptive measures during surgical sterilization or treatment and within 3 months after completion; (7) The researchers evaluated according to RECIST version 1.1 that there is at least one measurable lesion. (8) Understand and voluntarily sign a written informed consent form;
Exclusion criteria
Exclusion criteria: (1) The pathological type is small cell lung cancer, or mixed type lung cancer containing small cell lung cancer, or large cell neuroendocrine carcinoma or sarcomatoid carcinoma. (2) Expected to be surgical unresectable or only potentially resectable. (3) The patient is assessed to have a high risk of bleeding, such as the presence of active gastric ulcers, lesions of cavitary lung cancer, recent signs of bleeding in the tumor mass, pulmonary bleeding, hemoptysis (>3 ml of bright red blood) within 3 months, or tumor proximity to large blood vessels. (4) Participants in this study have received any systemic anti-tumor treatment, including chemotherapy, radiation therapy, immunotherapy (including but not limited to anti-PD-1, anti-PD-L1, anti-PD-L2 drugs or drugs acting on another co inhibitory T cell receptor), or targeted therapy (including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitors, etc.); (5) The patient has been previously diagnosed with other malignant tumors; (6) Previous interstitial lung disease, drug-induced interstitial disease, or any clinically proven active interstitial lung disease; At baseline, CT scan revealed the presence of idiopathic pulmonary fibrosis; (7) Evidence of serious or uncontrollable systemic diseases, such as unstable or uncompensated respiratory, cardiac, liver, or kidney diseases, as determined by researchers; (8) Any unstable systemic disease (including active infections, grade III hypertension, unstable angina, congestive heart failure, liver, kidney, or metabolic disorders); (9) Having a clear history of neurological or mental disorders, including epilepsy or dementia; (10) Severe chronic or active infections that require systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis infection; (11) Known to have active hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection, or other infectious diseases deemed unsuitable for inclusion; (12) Individuals who are known to have severe allergies to the investigational drug and/or any of its excipients; (13) Pregnant or lactating women; (14) Other researchers believe that it is not possible to join the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main pathological remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| pathologic complete response;objective response rate;Surgical R0 resection rate;disease control rate;Disease-free survival;Overall survival; | — |
Countries
PR China
Contacts
Public ContactJian Zeng
Zhejiang cancer hospital
Outcome results
None listed