Lung cancer
Conditions
Interventions
Case group:None
Sponsors
The First Affiliated Hospital of Henan University of CM
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Queue 1: 1. Stage IIIB to IV patients who are histologically diagnosed as non-small cell lung cancer and non-small cell lung cancer and defined by the TNM staging system of the 8th edition of IASLC; 2. Failure after only first-line standard treatment is defined as follows: Positive EGFR gene sensitive mutation: failed to be treated with at least one EGFR-TKI inhibitor; If there is EGFR-T790M mutation in patients, they can only be enrolled after receiving three generations of EGFR inhibitor treatment failure; Positive ALK gene rearrangement: failure after ALK inhibitor treatment; If the patient has only been treated with clotzotinib, he needs to receive another ALK inhibitor, which fails; ROS1 gene rearrangement positive: failure after treatment with ROS1 inhibitor; Other gene mutations are positive or driving genes are negative: failure to receive at least one treatment scheme in the past. Queue 2: 1. Extensive small cell lung cancer confirmed by histology; 2. Failure after only first-line standard treatment is defined as follows: The disease progression or side effects are intolerable during or after the first-line treatment. Queue 3: 1. BCLC stage B or C of patients with inoperable advanced hepatocellular carcinoma confirmed by histopathology or cytology; 2. Failure after only first-line standard treatment is defined as follows: The disease progression or side effects are intolerable during or after the first-line treatment. Queue 4: 1. Patients with unresectable advanced cholangiocarcinoma confirmed by histopathology or cytology 2. Failure after only first-line standard treatment is defined as follows: The disease progression or side effects are intolerable during or after the first-line treatment. 3. Age: 18-75 years; 4. The expected life is at least 3 months, and the ECOG score is 0-1; 5. There is a measurable focus defined in the RECIST 1.1 standard. The focus of previous irradiation can only be considered as a measurable focus if there is clear progress after radiotherapy and the focus of previous irradiation is not the only one; 6. The function of main organs is normal, that is, they meet the following standards: a) The blood routine examination standard should meet the following requirements (no blood transfusion and blood products within the first 14 days, no G-CSF and other hematopoietic stimulating factors were used for correction): b) Hemoglobin (HB) = 85 g/L; c) Absolute value of neutrophils (ANC) = 1.5 × 109/L(1500/m3) d) Platelet count (PLT) = 80 × 109/L e) Biochemical examination shall meet the following standards: Total bilirubin (TBiL) = 1.5? ULN For subjects with liver cancer or with evidence proving/suspected of suffering from Gilbert disease, TbiL = 3? ULN ALT and AST = 2.5? ULN, ALT and AST = 5? ULN Serum creatinine (Cr) = 1.5? ULN or endogenous creatinine clearance rate (CrCl) = 50 ml/min (Cockcroft-Gault formula: CrCL (mL/min)=[(140-age) * body weight (kg) * F]/(SCR (mg/dL) * 72. F=1 for male, F=0.85 for female, and SCr=serum creatinine); Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) = lower limit of normal value (50%); 7. Women of childbearing age must have taken reliable contraceptive measures or conducted pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and are willing to use appropriate methods of contraception during the test and 8 weeks after the last administration of the test drug. For males, it is necessa
Exclusion criteria
Exclusion criteria: 1. Patients who have previously used arotinib hydrochloride capsules or other anti-angiogenic drugs, or who are judged by the researcher to be unsuitable for anti-angiogenic drugs. 2. Imaging (CT or MRI) shows that the distance between the tumor focus and the large blood vessel is = 5mm, or there is a central tumor that invades the local large blood vessel; Or there is obvious pulmonary cavity tumor. 3. Medical history and complications 1) Patients with symptomatic brain metastasis, carcinomatous meningitis, spinal cord compression, or brain or leptomeningeal disease found by imaging CT or MRI during screening (patients with brain metastasis who have completed treatment 4 weeks before enrollment and whose symptoms have been stable for at least 2 weeks without progression can be enrolled, but they need to be evaluated and confirmed as having no symptoms of cerebral hemorrhage by brain MRI, CT or intravenous angiography); 2) The patient is participating in other clinical studies (excluding non-interventional studies), or less than 4 weeks from the end of treatment of the previous clinical study, or has previously participated in other PD-1/PD-L1 inhibitor studies due to PD-L1 expression status screening failure; 3) There have been or are currently suffering from other malignant tumors within 5 years, except cured cervical carcinoma in situ, skin cancer without melanoma and superficial bladder tumor [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)]; 4) Active, known or suspected autoimmune disease, including history of allogeneic organ transplantation, history of allogeneic hematopoietic stem cell transplantation, HIV positive history or history of acquired immune deficiency syndrome (AIDS). Except for the following: vitiligo, alopecia, Grave's disease, psoriasis or eczema that do not need systematic treatment in the past 2 years, asymptomatic or only need a stable dose of hormone replacement therapy to achieve stable hypothyroidism (caused by autoimmune thyroiditis), and type I diabetes that only need a stable dose of insulin replacement therapy, or childhood asthma has been completely alleviated, without any intervention after adulthood, Or the disease will not recur without external triggers; 5) Subjects who need systemic treatment with corticosteroids (>10mg/day prednisone equivalent dose) or other immunosuppressive drugs within 14 days before the administration of the study drug. However, you can join the group if: If there is no active autoimmune disease, it is allowed to use inhaled or local steroid and adrenocortical hormone with dose>10mg/day of prednisone; The dosage of systemic glucocorticoids in physiological dose does not exceed 10 mg/day of prednisone or other glucocorticoids in equivalent dose; Glucocorticoids are used as prophylactic drugs for hypersensitivity (such as drugs before CT examination); Systemic hormone therapy has been stopped for more than 2 weeks. 6) Patients whose adverse reactions (excluding alopecia) related to anti-tumor treatment after previous systemic anti-tumor treatment have not recovered to NCI-CTCAE = 1; 7) Abnormal coagulation function (INR>1.5 or prothrombin time (PT)>ULN+4 seconds or APTT>1.5 ULN), with bleeding tendency or undergoing thrombolytic or anticoagulant treatment; Note: On the premise that the international standardized ratio (INR) of the history time of thrombin disease is = 1.5, it is allowed to use small doses of heparin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;ORR;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS; | — |
Countries
China
Contacts
Public ContactTao Wang
The First Affiliated Hospital of Henan University of CM
Outcome results
None listed