Cancer Cachexia
Conditions
Interventions
Observation Group:None
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Voluntarily signed the written ICF and has provided informed consent for the experimental treatment. 2.Patients with histologically and/or cytologically confirmed malignant tumors. 3.Age>=18 years at the time of enrollment. 4.With an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 and a life expectancy of =3 months. 5.Meeting the diagnostic criteria for cachexia (based on the Fearon criteria). 6.Patient's BMI = 1.5 ×10^9/L (1500 /mm3); 2) platelet count >= 100 × 10^9/L (100,000/mm3); 3) hemoglobin>=80 g/L; (2) Kidney: 1) Creatinine clearance rate * (CrCl) calculated value >=50 mL/min * will be calculated by Cockcroft-Gault formula; CrCl (mL/min) = (140-age)× body weight (kg)×F/ (SCr (mg/dL) × 72) F=1 for males; F = 0.85 for female; SCr = serum creatinine. 2) proteinuria =28 g/L (4) Coagulation function: 1) International normalized ratio and activated partial thromboplastin time =50%. 8.Female patients of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to the first dose of study drug. (If the urine pregnancy test result is not conclusively negative, a serum pregnancy test will be required for confirmation, and the serum result will be considered definitive.) Furthermore: If a female patient of childbearing potential engages in sexual activity with a non-sterilized male partner, she must utilize a highly effective method of contraception starting from screening and must agree to continue its use for 120 days after the last dose of the study drug. Whether contraception can be discontinued after this period should be discussed with the investigator. If a non-sterilized male patient engages in sexual activity with a female partner of childbearing potential, he must utilize a highly effective method of contraception starting from screening until 120 days after the last dose of the study drug. Whether contraception can be discontinued after this period should be discussed with the investigator. 9.The patient is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Exclusion criteria
Exclusion criteria: 1.Presence of any gastrointestinal condition that could impair absorption, such as dysphagia, malabsorption, or uncontrolled vomiting; or currently requiring tube feeding or parenteral nutrition. 2.Presence of anorexia due to anorexia nervosa, psychiatric disorders, or pain that interferes with adequate food intake. 3.History of acquired immunodeficiency syndrome (AIDS). 4.Concurrent or planned use of medications that may increase appetite or body weight, such as: corticosteroids (with the exception of short-term dexamethasone use during chemotherapy), androgens, progestational agents, thalidomide, olanzapine, anamorelin, or other appetite stimulants. 5.Patients with Cushing's syndrome, adrenal insufficiency, or pituitary insufficiency; or poorly controlled diabetes mellitus. 6.Postmenopausal women with a history of abnormal vaginal bleeding within the past year; or premenopausal women with a history of abnormally thickened endometrium (>15 mm) within the past year. 7.Presence of clinical or radiographic evidence of current gastrointestinal obstruction. 8.Presence of any uncontrolled concurrent illness, including but not limited to decompensated cirrhosis, renal failure, uncontrolled metabolic disorders, severe active peptic ulcer disease/gastritis, or psychiatric/social conditions that would limit compliance with study requirements or impair the ability to provide written informed consent. 9.Within 12 months prior to the first dose: Unstable angina requiring hospitalization, myocardial infarction, congestive heart failure (New York Heart Association Class II or higher), vascular disease (e.g., aortic aneurysm at risk of rupture), or other cardiac conditions that may interfere with the safety assessment of the investigational product (e.g., poorly controlled arrhythmia, myocardial ischemia).Within 6 months prior to the first dose: History of esophageal/gastric varices, severe ulcer, gastrointestinal perforation and/or fistula, gastrointestinal obstruction (including incomplete obstruction requiring parenteral nutrition), intra-abdominal abscess, or acute gastrointestinal bleeding. 10.Within 6 months prior to the first dose: Any arterial thromboembolic events; venous thromboembolic events of Grade 3 or higher per NCI CTCAE v5.0 (requiring emergency medical intervention, e.g., pulmonary embolism or intracardiac embolism); or hypertensive crisis. Within 1 month prior to the first dose: Acute exacerbation of chronic obstructive pulmonary disease. Current status (at screening): Hypertension with systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg after oral antihypertensive therapy. 11.Known allergy/hypersensitivity to any component of the investigational product. 12.Occurrence of severe infections within 4 weeks prior to the first dose, including but not limited to any condition requiring hospitalization. 13.Pregnancy or lactation. 14.Presence of any condition—including medical history, current illnesses, treatments, or laboratory abnormalities—that may confound study results, compromise patient participation throughout the study, or render participation not in the patient's best interest.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with improved appetite based on the A/CS-12 scale at Week 4.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with > 5% weight gain from baseline;Incidence and severity of adverse events;Clinically significant abnormal laboratory test results; | — |
Countries
China
Contacts
Public ContactSuxia Luo
Henan Cancer Hospital
Outcome results
None listed