Advanced non-small cell lung cancer
Conditions
Interventions
Case series:Camrelizumab combined with Famitinib Malate Capsules
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Subjects are diagnosed with histologically or cytologically confirmed NSCLC; 2. EGFR and ALD genes were negative or could not be detected; 3. The patient has previously received standard first-line therapy and the treatment has failed or returned; 4. Male or female aged 18-70 years; 5. Life expectancy >=3 months; 6. ECOG performance status of 0 to 2; 7. There is at least one measurable lesion according to the RECIST 1.1 standard; 8. The functions of important organs meet the following requirements (no blood component or cell growth factor correction treatment was used within 14 days before the first application): Neutrophil absolute count >=1.5x10^9/L; Platelet >=90x10^9/L; Hemoglobin >=90 g/L; Serum albumin >=30g/L; TSH <=1 ULN (if abnormal, FT3 and FT4 levels should be examined at the same time, if FT3 and FT4 levels are normal, they can be included in the group); bilirubin <=1 ULN (within 7 days before the first application); ALT and AST <=3 ULN (within 7 days before the first application); AKP <=2.5 ULN, if accompanied by bone metastasis < 5 ULN; Serum creatinine <=1.5 ULN; 9. Two medically recognized contraceptive measures (such as IUD, contraceptive pill or condom) should be used during the study treatment period and within 3 months after the end of the study treatment period for women of non-surgical sterilization or childbearing age; The serum or urine HCG test of women of non-surgical sterilization in childbearing age must be negative within 7 days before the enter the study; It must be non lactation period; For male subjects whose partners are women of childbearing age, effective contraceptive methods should be used during the trial and within 3 months after the last administration of SHR-1210; 10. Subjects should be voluntarily participate in clinical trials and informed consent form should be signed.
Exclusion criteria
Exclusion criteria: 1. The subject has been treated with anti-PD-1, anti-PD-L1 antibody or with famitinib before. 2. Severe allergy to famitinib, SHR-1210 or any component of monoclonal antibody; 3. CT or MRI shows that the tumor invades or blurs the border with the blood vessels, and other cases that the tumor is highly likely to invade the important blood vessels during the treatment period and cause fatal bleeding. 4. HIV infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA >=500 IU/ml), hepatitis C (HCV antibody positive, and HCV-RNA higher than the detection limit of the analysis method) or co infection with hepatitis B and C; 5. Immunosuppressive drugs have been used in the past 14 days before the first use of SHR-1210, excluding nasal spray and inhaled corticosteroids or systemic steroids with physiological dose (i.e. not more than 10 mg/day of prednisolone or other corticosteroids with physiological dose of equivalent drugs), or live attenuated vaccines are to be inoculated within 4 weeks before the first use of shr-1210 or during the study period; 6. Subjects with known interstitial lung disease or history or evidence of noninfectious pneumonia treated with corticosteroids, or who may interfere with the detection or management of suspected drug-related pulmonary toxicity; 7. Subjects with symptomatic central nervous system metastasis; 8. Subjects with hypertension who cannot be reduced to the normal range (systolic blood pressure = 140 mmHg / diastolic blood pressure = 90 mmHg) after treatment with antihypertensive drugs 9. There are clinical symptoms or diseases of the heart that can not be well controlled, such as: (1) NYHA grade 2 or above heart failure; (2) unstable angina; (3) myocardial infarction within one year; (4) clinically significant supraventricular or ventricular arrhythmias that need treatment or intervention; (5) QTc > 450ms (male); QTc > 470ms (female); 10. There are many factors affecting the absorption of oral drugs, such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction. 11. Routine urine test indicated that urine protein >=(+ +), or 24-hour urine protein >=1.0g; 12. The blood coagulation function was abnormal (INR > 2.0, Pt > 16S), with bleeding tendency or undergoing thrombolysis or anticoagulation treatment, and low-dose aspirin and low-molecular-weight heparin were allowed for prophylactic use; 13. Subjects at risk of gastrointestinal bleeding include the following: (1) Active peptic ulcer and occult blood in stool (++ - +++); (2) Subjects with history of black stool and hematemesis within 3 months; (3) For occult blood in stool (+) or (+/-), stool routine examination shall be carried out within 1 week, and gastroscopy shall be carried out for those who are still (+) or (+/-). If there is ulcer or bleeding disease, and the treating doctor thinks there is potential bleeding risk; 14. Severe infection (such as intravenous drip of antibiotics, antifungal drugs or antiviral drugs) occurred within 4 weeks before the first administration, or fever(> 38.5 degree C) of unknown cause occurred during screening / before the first administration; 15.Over operation, open biopsy or significant trauma were performed 28 days before admission. 16. Subjects with the history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation is known; 17. Pregnant or lactating women; Those with fertility who are unwillin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;???; | — |
Countries
China
Contacts
Public ContactJunxun Ma
Chinese PLA General Hospital
Outcome results
None listed