Adenocarcinoma of lung
Conditions
Interventions
Experimental group:Befortinib combined with Rivaroxaban
Sponsors
Affiliated Hospital of Guangdong Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily signs the informed consent form. 2. Age = 18 years old and = 80 years old. 3.ECOG score = 1.5×10^9/L, platelet count >= 75× 10^9/L, hemoglobin >= 80 g/L (no hematological components or cell growth factor corrective treatment drugs are allowed within 14 days before enrollment); Blood biochemistry: Total bilirubin <= 1.5 times the upper limit of the normal value, AST/ALT<= 2.5 times the upper limit of the normal value (5 times the upper limit of the normal value if liver metastasis is present), serum creatinine <= 1.5 times the upper limit of the normal value. Coagulation function: International Normalized ratio (INR)< 1.5 (anticoagulation therapy is not allowed within 14 days before enrollment). 13. Did not participate in other clinical trials that might affect the results of this study.
Exclusion criteria
Exclusion criteria: 1.Currently or previously suffering from other malignant tumors (except for skin basal cell carcinoma or squamous cell carcinoma that has been fully treated, and cervical carcinoma in situ), unless radical treatment has been undergone and there is evidence of no recurrence or metastasis within the past 5 years; 2.Currently or previously suffering from other malignant tumors (except for skin basal cell carcinoma or squamous cell carcinoma that has been fully treated, and cervical carcinoma in situ), unless radical treatment has been undergone and there is evidence of no recurrence or metastasis within the past 5 years; 3.Within 28 days before the start of the study drug treatment, having undergone surgical procedures, but minor surgeries that the researcher deems do not affect participation in the trial (such as tooth extraction, etc.) are excluded; or patients planning to undergo major surgeries during the study period, or those with severe non-healed wounds, ulcers or fractures at the screening stage. 4.Within the previous 2 weeks, having experienced significant deterioration in symptoms or signs (such as the appearance of a large amount of pleural effusion within the previous 2 weeks, and considering screening after controlling the pleural effusion), and the researcher determines that they are not suitable for participating in the trial. 5.The toxicity reactions after previous treatment have not recovered, and according to CTCAE V5.0 before the administration of the study drug, they are grade 2 or above, except for hair loss. 6.Having spinal cord compression, unstable brain metastases requiring steroid treatment within 4 weeks before enrollment. Patients with asymptomatic brain metastases or those whose brain metastases are stable for more than 4 weeks after treatment and do not require steroid treatment can be enrolled. Patients with meningeal metastases are not eligible for enrollment. 7.Any clinical evidence indicating severe or uncontrolled diseases, which the researcher considers unsuitable for participating in this clinical trial or may affect the patient's compliance with the study protocol, such as patients with uncontrolled hypertension after drug treatment (systolic blood pressure SBP > 160 mmHg or diastolic blood pressure DBP > 100 mmHg), patients with active bleeding-prone conditions, patients with active infections (such as hepatitis B, hepatitis C, HIV-1/2 antibody positive, syphilis spirochete antibody positive (with negative titration results excluded)), patients with active hepatitis B defined as positive hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg), and HBV DNA >=2000 IU/ml (equivalent to 104 copies/ml), patients with active hepatitis C defined as HCV RNA above the detection limit. Active hepatitis B is defined as positive hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg), and HBV DNA = 2000 IU/ml (equivalent to 104 copies/ml). Active hepatitis C is defined as HCV RNA above the detection limit. 8.In the resting state, if the corrected QT interval (QTcF) result of the electrocardiogram during the screening period is abnormal, and the results are measured twice at least 4 hours apart, the average QTcF of 3 electrocardiogram examinations: for males, >= 450 msec, for females, >= 470 msec. 9.Various clinically significant arrhythmias, conduction abnormalities, and resting ECG morphology abnormalities, such as complete left bundle branch block, third-degree conduction bloc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of thrombosis within 4 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response (DOR);Objective Response Rate (ORR);The incidence of thrombosis within 7 months;Progression-free survival (PFS); | — |
Countries
China
Contacts
Public ContactSu Wenmei
Affiliated Hospital of Guangdong Medical University
Outcome results
None listed