lung squamous carcinoma
Conditions
Interventions
Case series:Apatinib qd+SHR1210 q2w
Sponsors
The General Hospital of the People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. aged from 18 to 75 years old, both male and female; 2. histologically or cytologically diagnosed IIIb and IV lung squamous carcinoma; 3. patient didt accepted systemic treatment previously; 4. ECOG PS score is 0-2; 5. patient has measurable lesions which conform to the RECIST standard version 1.1; 6. the estimated survival period is no less than 3 months; 7. The main organs function normally without severe abnormalities of blood, heart, lung, liver, kidney and immunodeficiency diseases. Laboratory tests should meet the following requirements: (1)routine blood test should be in line with (no blood transfusion within 14 days): HGB no less than 110g/L; WBC no less than 4 x 10^9/L; NEUT is no less than 2 x 10^9/L; PLT no less than 100 x 10^9/L; (2) biochemical tests should meet the following criteria: BIL no more than 1.5 times of the normal upper limit (ULN)(normal patient), 2.5 times of ULN ( liver metastases patients); ALT and AST are no more than 2.5 times of ULN, 5 times of ULN ( liver metastases patients); serum creatinine is no more than 1.5 times of ULN or endogenous creatinine clearance rate is no less than 50ml/min ( Cockcroft-Gault formula); Thyrotropin (TSH) < ULN or T3 and T4 levels are normal; Occult blood (-); Urine routine is normal or urine protein < (+ +) or 24 hours urine protein <1.0g; 8. coagulation function is normal, no active bleeding and thrombosis diseases: INR no more than 1.5 times of ULN; APTT less than 1.5 times of ULN; PT no more than 1.5 times of ULN. 9. childbearing age women patient: negative pregnancy tests (serum or urine) within 14 days of admission and appropriate contraceptive methods should be used voluntarily during the observation period and 8 weeks after the last administration of Apatinib Mesylate; men patient: accept the surgical sterilization or consent to contraception during the observation period and 8 weeks after the last administration of Apatinib Mesylate; 10. patient join the study voluntarily and sign informed consent form (ICF); 11. patient should have good compliance and can be followed the efficacy and adverse events by staffs according to the protocol.
Exclusion criteria
Exclusion criteria: 1. Have previously received targeted therapy, or immunotherapy, or those who received chemotherapy within 6 months before the first administration; 2. Known hypersensitivity reactions to apatinib, SHR-1210, or any component contained in the preparation; 3.Imaging (CT or MRI) showed that the tumor invading the large vessels, or the boundary with the blood vessel is unclear; 4. Imaging (CT or MRI) shows the presence of any pulmonary cavity or necrotic lesions; 5. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). Positive test for hepatitis B virus (HBV DNA = 500 IU/ml) or hepatitis C virus ribonucleic acid (HCV antibody positive, and HCV RNA) indicating acute or chronic infection, or co-infection with hepatitis B and C; 6. Subjects used immunosuppressive drugs excluding nasal spray and inhaled corticosteroids or systemic steroids at physiological doses (prednisolone=10 mg/day or other corticosteroids of the same pharmacophysiological dose) within 14 days before the first dos; 7. Within 4 weeks before the first dose or plan to receive live attenuated vaccine during the study period; 8. Suffering from high blood pressure and not being well controlled by antihypertensive medication (systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg); 9. Subjects with grade II coronary heart disease, poorly controlled arrhythmias (QTc interval > 450 ms for males and QTc interval > 470 ms for females), and cardiac insufficiency; 10. There are many factors that affect the absorption of oral drugs, such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction; 11. Urinary routine indicates urinary protein= ++ and confirmed 24-hour urine protein> 1.0 g; 12. Coughing blood within 3 months before enrollment; 13. Thrombotic disease that requires long-term anticoagulation with warfarin or heparin, or long-term antiplatelet therapy (aspirin =300 mg/day or clopidogrel =75 mg/day); 14. The patient has severe infection within 4 weeks before first administration(such as the need for intravenous antibiotics, antifungals or antivirals), or unexplained fever before administration and screening, =38.5 °C; 15. Have undergone major surgery, open biopsy, or significant trauma within 28 days before enrollment; 16. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 17. Female subjects who are pregnant or lactation, or childbearing patients unwilling or unable to take effective contraception; 18. Other factors lead to patients can not participate in this clinical study judgment by investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;ORR;OS;QoL;adverse event;Biomarker explore; | — |
Countries
China
Contacts
Public ContactJinliang Wang
The General Hospital of the People's Liberation Army
Outcome results
None listed