Lung Cancer
Conditions
Interventions
HMT+Camrelizumab:HMT+Camrelizumab
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) According to the 8th edition of the TNM staging of lung cancer by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification,diagnosed as advanced (Stage IV) non-small cell lung cancer by cytology or histology,with inoperable treatment and unable to receive radical concurrent radiotherapy and chemotherapy. 2) Aged 18 Years to 70 Years patients voluntarily participate in this study. 3) ECOG PS Scoring: 0~1 point. 4) The expected survival period is >= 3 months. 5) Previously received systemic PD-1 or PD-L1 monoclonal antibody treatment benefit, and according to the RECIST1.1 standard to evaluate the disease progression. Except for patients with hyperprogressive disease. 6) Participants must have normal organ and marrow function as defined below: Blood routine examination criteria (no blood transfusion and blood products within 14 days, no correction by G-CSF and other hematopoietic stimuli): hemoglobin (HB) >= 90g/L; neutrophil absolute (ANC) >= 1.5 x 10^9/L; platelet (PLT) >= 90 x 10^9/L;total bilirubin (TBIL) = 50mL/min (Cockcroft-Gault formula);INR = 50%; QTcF <= 450ms; alkaline phosphatase <= 2.5 ULN.
Exclusion criteria
Exclusion criteria: 1) Women during pregnancy or breastfeeding. 2) Have previously received any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody treatment, or any other antibody or drug treatment for T cell costimulation or checkpoint pathway, such as ICOS or agonists (such as CD40,CD137,GITR,OX40, etc.). 3) Enroll in another clinical study at the same time, unless it is an observational, non-interventional clinical study or in the follow-up period of an interventional study (defined as the time between the first use of PD-1 monoclonal antibody and the last clinical study is more than 28 days or more than 5 half-lives of the study drug). 4) Can not recover from the toxicity and/or complications of the previous interventions to NCI-CTC AE 10 mg/day prednisone equivalent dose) or other immunosuppressive drugs for systemic therapy within 14 days before the use of PD-1 monoclonal antibody. The following exceptions are: a) If there is no active autoimmune disease, inhaled, ophthalmic or topical steroids and adrenal corticosteroids with a dose not exceeding 10 mg/day of prednisone are allowed. b) The physiological dose of systemic glucocorticoids does not exceed 10 mg/day prednisone or equivalent doses of other glucocorticoids. c) Glucocorticoids are used as preventive medications for hypersensitivity reactions (such as medication before CT examination and pretreatment before chemotherapy). 8) A known history of primary immunodeficiency virus infection. 9) Re-challenge to have received abdominal radiotherapy and taken radioactive substances within 28 days before using PD-1 monoclonal antibody. 10) Active or previously recorded inflammatory bowel disease (such as Crohns disease, ulcerative colitis, chronic diarrhea). Patients with chronic diarrhea who had no recurrence within 2 years before enrollment were excluded. 11) Re-challenge to have a history of gastrointestinal perforation and/or fistula within 6 months before using PD-1 monoclonal antibody. 12) Active gastrointestinal bleeding within 1 week before the first HMT. Only patients with fecal occult blood, no melena, or bloody stools are excluded, except for hemorrhoids bleeding. 13) Suffered from other active malignant tumors within 5 years before enrollment. Except for locally curable cancers (shown as cured), such as basal or skin squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ. 14) Re-challenge to have received major surgery within 28 days before using PD-1 monoclonal antibody (defined by the investigator, such as open biopsy, severe trauma, etc.). Those who
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS;PFS; | — |
Countries
China
Contacts
Public ContactMeijuan Huang
West China Hospital, Sichuan University
Outcome results
None listed