lung sarcomatoid carcinoma
Conditions
Interventions
experimental group:camrelizumab alone or in combination with Apatinib mesylate
Sponsors
The First Affiliated Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Sign a written informed consent; Be willing and able to provide written informed consent/assent for the trial; 2) Male or female aged 18-80 years; 3) Patients with histologically- or cytologically-confirmed diagnosis of local advanced or metastatic lung sarcomatoid carcinoma (Stage IIIB/IIIC/IV, according to IASLC/AJCC 8th Edition of TNM Classification for Lung Cancer)who are unresectable and unable to receive radical chemoradiotherapy or have progressed on/ are intolerant / refuse to receive chemotherapy to systemic chemotherapy; 4) Have confirmed PD-L1 positive tissue sample by PD-L1 antibody test; 5) Histologically- or cytologically-confirmed of no EGFR, ALK, ROS1, MET gene mutation; 6) At least one measurable disease based on Response Evaluation Criteria in Solid Tumors 1.1(Target focus located in the previous radiotherapy area or after local treatment can also be selected as target focus if it is confirmed has progressed and meets recist1.1 standard); 7) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 2 with life expectancy >=3 months; 8) The blood test (WBC, ANC, RBC, Hb, PLT), liver function (ALT, AST, ALP, LDH, TBil, DBil), renal function (Cr, BUN), electrolyte (K, Na, Cl, Ca, P, Mg), blood glucose, electrocardiogram, cardiac function and coagulation meet the treatment requirement; 9) Have no plan for pregnant within 3 years and be willing to use effective methods of contraception; 10) Voluntarily comply with the treatment protocol.
Exclusion criteria
Exclusion criteria: 1) Currently participating or has participated in a study of an investigational agent; 2) Previously therapy with anti-PD-1, anti-PD-L1, anti- PD-L2 or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways (such as OX40, CD137, etc.); 3) The target lesion has received palliative radiation therapy within 7 days before the first dose. For patients who have received non-target lesion palliative radiation therapy 7 days before the first dose, they must meet all the following conditions before they can be included in the group: there is currently no radiation-related toxic reaction, no need to take glucocorticoids, and exclude radioactivity Pneumonia; patients whose target lesions have progressed after radiation therapy can be enrolled; 4) Has received or will receive a live vaccine within 4 weeks prior to the first study therapy (seasonal flu vaccines that do not contain live vaccine are permitted) ; 5) Is receiving any other form of immunosuppressive medication prior to the first dose of study therapy with the exception of nasal spray, inhalator , other route administration of local glucocorticoid treatment or systemic glucocorticoid treatment = 1 week after treatment of brain metastatic lesions can be included as long as they meet all the following criteria: measurable lesions outside the central nervous system, no medulla oblongata or spinal cord metastases, no previous history of intracranial hemorrhage, glucocorticoid treatment was stopped 7 days before the first study therapy; 9) Any unstable systemic disease: including, but not limited to, active infections, congestive heart failure [New York Heart Association (NYHA) classification >= Class II], severe arrhythmia, liver, kidney, or metabolic diseases requiring medical treatment; Type I and Type II respiratory failure; compression of vital organs (such as the esophagus), superior vena cava, or invasion of mediastinal vessels, heart, etc .; 10) Has known history or active human immunodeficiency virus (HIV-1 and HIV-2 antibody positive ), syphilis; 11) Has known active tuberculosis or currently tuberculosis requires medical treatment, including but not limited to pulmonary tuberculosis; 12) Untreated active hepatitis B; Note: Patients with hepatitis B who meet the following criteria are eligible: Patients with hepatitis B virus (HBV) with a viral load <1000 copies / ml (200IU / ml) or less than the lower limit of detection before the first dose need to continue or start a full course of standardized antiviral therapy during the study; Patients with HBcAb-positive/HBsAg-negative/HBsAb-negative/HBV-DNA negative do not need to receive prophylactic anti-HBV therapy, but need to closely monitor virus reactivation; 13) Patients with hepatitis C virus (HCV-antibody positiv
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;DCR;TTR;DOR;Safety and tolerance; | — |
Countries
China
Contacts
Public ContactMingfang Zhao
The First Affiliated Hospital of China Medical University
Outcome results
None listed