Locally Advanced Nasopharyngeal Carcinoma
Conditions
Interventions
Experimental group:Megestrol acetate oral suspension + radiotherapy + Nimotuzumab
Control group :Radiotherapy + Nimotuzumab
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the written ICF. 2. Age >= 18 years at the time of enrollment. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0–2. 4.Anticipated life expectancy >= 3 months. 5. Histologically or cytologically confirmed locally advanced (Stage III–IVa) nasopharyngeal carcinoma according to the International Association for Cancer Research and the American Joint Committee on Cancer TNM staging classification, 8th edition. 6. Have received induction chemotherapy and are planned for radiotherapy. 7. Meet the diagnostic criteria for pre-cachexia or cachexia (based on the Fearon diagnostic criteria). Diagnostic criteria for pre-cachexia require all of the following: (1) Loss of appetite (based on patient report); (2) Unintentional weight loss >0 and 5 mg/L). Diagnostic criteria for cachexia: Any one of the following, combined with loss of appetite or systemic inflammation: (1) Unintentional weight loss >5% within the past 6 months; (2) BMI 2% within the past 6 months; (3) Appendicular skeletal muscle index meeting the diagnostic criteria for sarcopenia (male 2% within the past 6 months. 8. Adequate organ function confirmed by the following requirements: (1) Hematology (no blood component or growth factor support within 7 days prior to the start of study treatment): Absolute neutrophil count (ANC) >= 1.5 × 10?/L (1,500/mm³); Platelet count >= 100 × 10?/L (100,000/mm³); Hemoglobin >= 90 g/L. (2) Renal: Calculated creatinine clearance* (CrCl) >= 50 mL/min. CrCl will be calculated using the Cockcroft-Gault formula: CrCl (mL/min) = (140 – age) × weight (kg) × F / (SCr (mg/dL) × 72) , F = 1 for males; F = 0.85 for females; SCr = serum creatinine. Urine protein = 28 g/L. (4) Coagulation: International normalized ratio (INR) and activated partial thromboplastin time (APTT) = 50%. 9.Female patients of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to the first dose (if urine pregnancy test result is not definitively negative, a serum pregnancy test is required, and the serum result shall prevail). If a female patient of childbearing potential engages in sexual activity with a non-sterilized male partner, she must use acceptable contraception from screening and agree to continue its use for 120 days after the last dose of study drug; discussion with the investigator is required regarding discontinuation of contraception after this period. If a non-sterilized male patient engages in sexual activity with a female partner of childbearing potential, he must use effective contraception from screening until 120 days after the last dose; discussion with the investigator is required regarding discontinuation of contraception after this period. 10.The patient is will
Exclusion criteria
Exclusion criteria: 1.Having tumors other than nasopharyngeal carcinoma, such as other head and neck cancers of unknown primary origin. 2.Presence of any condition affecting gastrointestinal absorption, such as dysphagia, malabsorption, or uncontrolled vomiting; currently receiving tube feeding or parenteral nutrition. 3.Presence of anorexia nervosa, anorexia due to psychiatric disorders, or pain that makes eating difficult. 4.Having acquired immunodeficiency syndrome (AIDS). 5.Currently using or planning to use other medications that increase appetite or body weight, such as: adrenal corticosteroids (except short-term use of dexamethasone during chemotherapy), androgens, progestins, thalidomide, olanzapine, anamorelin, or other appetite stimulants. 6.Patients with Cushing's syndrome, adrenal or pituitary insufficiency; poorly controlled diabetes mellitus. 7.Postmenopausal women with a history of abnormal vaginal bleeding within the past year; premenopausal women with a history of endometrial thickening (>15 mm) within the past year. 8.Current imaging or clinical manifestations of gastrointestinal obstruction. 9.Presence of uncontrolled concurrent illnesses, including but not limited to decompensated liver cirrhosis, renal failure, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis, or psychiatric/social conditions that would limit the patient's compliance with study requirements or impair the patient's ability to provide written informed consent. 10. Within 12 months prior to the first dose, history of unstable angina, myocardial infarction, congestive heart failure (Class II or higher as defined by the New York Heart Association functional classification), or vascular disease (e.g., aortic aneurysm at risk of rupture), or other cardiac impairment that may affect the safety evaluation of the study drug (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 bowel obstruction requiring parenteral nutrition), intra-abdominal abscess, or acute gastrointestinal bleeding. 11. Within 6 months prior to the first dose, any arterial thromboembolic event, Grade 3 or higher venous thromboembolic event per NCI CTCAE v5.0 (requiring urgent 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, or current hypertension with systolic blood pressure >=160 mmHg or diastolic blood pressure =100 mmHg despite oral antihypertensive therapy. 12. Known allergy to any component of the study drug. 13. Within 4 weeks prior to the first dose, occurrence of severe infection, including but not limited to conditions requiring hospitalization. 14. Pregnant or breastfeeding women. 15. Any disease, treatment, or laboratory abnormality, either past or present, that may confound the study results, interfere with the patient's full participation in the study, or for whom participation may not be in the patient's best interest.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of persons with a weight loss of 5% or more from baseline; | — |
Countries
China
Contacts
Public ContactSufang Qiu
Fujian Cancer Hospital
Outcome results
None listed