cancer anorexia-cachexia syndrome
Conditions
Interventions
Treatment group :Nanocrystalline Megestrol Acetate Oral Suspension (5ml, QD, up to 12 weeks starting from immunotherapy)+PD - (L) 1 inhibitor (Q3W, up to PD)+chemotherapy regimen
Control group :PD - (L) 1 inhibitor (Q3W, up to PD)+chemotherapy regimen
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria for advanced non-small cell lung cancer: (1) According to the TNM staging classification of lung cancer (8th Edition) of the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification, patients with locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-small cell lung cancer (NSCLC) who cannot undergo complete surgical resection and radical chemoradiotherapy, confirmed by histology or cytology; (2) The subject had not received systemic chemotherapy for metastatic disease or only completed the first cycle of immunochemotherapy. For subjects with previous adjuvant/neoadjuvant chemotherapy or radical concurrent or sequential chemoradiotherapy for non-metastatic disease, if disease progression occurred >6 months after the end of the last treatment, they were eligible to participate in this study; (3) At least one measurable tumor lesion according to RECIST v1.1; 2. Meet the diagnostic criteria of pre-cachexia or cachexia: (1) The following three pre-cachexia diagnostic criteria should be met: 1) Involuntary weight loss 5 mg/L); 3) Decreased appetite (FAACT-A/CS 12 score 5 mg/L): 1) Involuntary weight loss >5% in recent 6 months; 2) Weight loss >2% when BMI =6 months; (5) Good organ function: 1) Hematology: neutrophils >=1.5×10^9/L, hemoglobin >=9 g/dL, platelets >=100×10^9/L; 2) Liver function: bilirubin =3 g/dL; 3) Coagulation function: international normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (APTT) =60 mL/min (calculated by Cockcroft-Gault formula); 5) Urinary protein =50%; (6) Female patients of childbearing potential must have a urine or serum pregnancy test within 3 days before the first dose (if the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test is required, and the serum pregnancy result shall prevail), and the result must be negative. If a female patient of childbearing potential has sexual intercourse with a non-sterilized male partner, the patient must use an acceptable method of contraception from screening and must agree to continue using contraception for 120 days after the last dose of the study drug; whether to stop contraception after this time point should be discussed with the investigator. If a non-sterilized male patient has sexual intercourse with a female partner of childbearing potential, the patient must use ef
Exclusion criteria
Exclusion criteria: 1. Cancer specific exclusion criteria: (1) Active or untreated CNS metastases (e.g., brain or leptomeningeal metastases) identified by CT or magnetic resonance (MRI) evaluation during screening and previous imaging evaluation. Patients who had received previous treatment for brain or leptomeningeal metastasis, and had been stable for >=2 months, and had stopped systemic hormone therapy (>10 mg/d prednisone or equivalent) for >4 weeks before randomization could participate in the study; (2) Uncontrolled tumor related pain; (3) Thromboembolic disease, ascites or lower extremity edema in the past 6 months; (4) Patients with a history of malignancies other than lung cancer within 5 years before randomization, but with negligible risk of metastasis or death (e.g., the expected 5-year overall survival rate >90%), and with the exception of malignancies that are expected to be cured after treatment, such as cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer treated with radical surgery, and ductal carcinoma in situ treated with radical surgery; (5) There was toxicity from previous antitumor therapy without remission, which was defined as failure to return to NCI CTCAE version 5.0 grade 0 or 1 (except for hair loss) or to the level specified in the enrollment/exclusion criteria. 2. General medical exclusion criteria: (1) Women who are pregnant, breastfeeding or planning to become pregnant during the study; (2) Patients with hepatitis B (HBsAg known to be positive and HBV DNA detected by each research center is >=1000 cps/mL or 200 IU/mL or >= the upper limit of its normal value) or hepatitis C: 1) Patients with previous hepatitis B virus (HBV) infection must be tested for HBV DNA, and only those with negative HBV DNA (HBV DNA <1000 cps/mL or 200 IU/mL or lower than the upper limit of its normal value) are eligible to participate in this study; 2) Among patients with positive hepatitis C virus (HCV) antibody, only patients with negative polymerase chain reaction (PCR) HCV ribonucleic acid (RNA) can participate in this study; (3) Patients with positive human immunodeficiency virus (HIV) test results; (4) Had undergone major surgery (other than diagnostic surgery) within 28 days before randomization, or was expected to undergo major surgery during the study; (5) Important cardiovascular diseases, such as heart disease (grade II or higher) defined by the New York Heart Association, myocardial infarction, unstable arrhythmia, unstable angina, cerebrovascular accident or transient ischemic attack within 3 months before randomization; Patients with known coronary artery disease, congestive heart failure that does not meet the above criteria, or left ventricular ejection fraction <50% must be treated with the best stable treatment plan considered by the attending doctor, and cardiologists can be consulted when necessary; (6) Serious infection occurred within 4 weeks before the first administration, including but not limited to comorbidities, sepsis or severe pneumonia requiring hospitalization; Active infection (excluding antiviral therapy for hepatitis B or C) who had received systemic anti-infective therapy within 2 weeks before the first dose. 3. Exclusion criteria related to medication: (1) There are any conditions affecting gastrointestinal absorption, such as dysphagia, malabsorption, uncontrollable vomiting, etc.; Patients with food intake difficulties or w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with >5% weight gain from baseline (Week 12); | — |
Secondary
| Measure | Time frame |
|---|---|
| Appetite (FAACT-A/CS 12);Life quality(EORTC QLQ-C30);Anxiety and depression (HADS);PFS rate of 6m;PFS rate of 1y;Treatment compliance ;L3-SMI;CRP, IL-1, IL-6, TNF-a et al;Prealbumin, albumin, hemoglobin;Analysis of lymphocyte subpopulations; | — |
Countries
China
Contacts
Public ContactSong Qi
Chinese PLA General Hospital
Outcome results
None listed