lung cancer
Conditions
Interventions
Experimental group:First-line immunotherapy combined with chemotherapy was combined with megestrol acetate oral suspension
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (stage III-IV) that cannot be treated with radical surgery or radiotherapy; 2) have not received systematic treatment before; 3) Negative for known driver gene mutations; 4) Have at least one measurable lesion that meets the RECIST v1.1 definition; (5) Meet the criteria for the pre-diagnosis of cachexia (refer to the 2016 ESPEN terminology consensus), and meet the following conditions: (1) the maximum weight loss from baseline 6 months ago <5%; ? Anorexia (there are complaints of anorexia or anorexia/cachexia sub-table FAACT-A/CS score =37 points); ? Serum C-reactive protein CRP=5mg/L); 6) Age =65 years old, male or female; 7)ECOG score 0 or 1 (patients with ECOG score 2 were allowed to enroll, as judged by the investigator); 8) The main organ function is normal, and the laboratory examination indicators during the screening period must meet the following standards: Absolute neutrophil count =1.5×109/L; Platelet =100×109/L; Hemoglobin =90g/L; Serum bilirubin =1.5× upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT)=2.5×ULN, no liver metastasis; If there is liver metastasis, AST and ALT=5×ULN; Serum creatinine <1.5 ULN; International standardized ratio =1.5; 9) Life expectancy =3 months;
Exclusion criteria
Exclusion criteria: 1) Other previous malignancies within 5 years, excluding non-melanoma skin cancers; 2) Patients who relapse after radical resection during adjuvant therapy or within 6 months after completion of adjuvant therapy; 3) Uncontrolled or untreated active brain metastases, mental abnormalities, or loss of cognitive ability; 4) The subject has cachexia caused by causes not limited to cancer, such as chronic respiratory failure, chronic obstructive pulmonary disease, chronic and persistent congestive heart failure, acquired immune deficiency syndrome, etc.; 5) Intentional weight loss through any measure; 6) Patients with a history of allergy to early supportive treatment modalities (megestrol acetate or other components of the formulation); 7) Concurrent or planned adrenal steroid, androgen or progesterone therapy; 8) Serious oral or dental disease that prevents proper oral intake of food. 9) Any lung disease that requires daily oxygen support; 10) Known to have a functional or mechanical gastrointestinal disease that interferes with proper nutrient absorption, such as mechanical obstruction of the digestive tract, malabsorption, or refractory vomiting (vomiting more than 5 times a week), chronic diarrhea, etc.; 11) thromboembolic disease, ascites or lower limb edema within the past 6 months; 12) Active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever > 38?, active infection and other serious complications; 13) Any heart failure with a New York Heart Association functional rating of III-IV, high blood pressure that cannot be effectively controlled, etc. 14) The subject is currently participating in any other cancer cachexia study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in body composition;Progression Free Survival, PFS ;Objective response rate, ORR;Overall survival, OS; | — |
Countries
China
Contacts
Public Contactzhe zhao
Beijing Hospital
Outcome results
None listed