Primary liver cancer
Conditions
Interventions
Placebo group:Use a placebo
Megestrol Acetate group:Megestrol Acetate
Sponsors
Southern Medical University Southern Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.HCC:(1). Patients with unresectable primary hepatocellular carcinoma (HCC) confirmed by imaging or histopathology; (2). Have not previously received immunotherapy and/or targeted drug therapy; (3). Child-Pugh score =10 mm, or CT/MRI scan with short axis >=15 mm for lymph node lesions), and the lesion has not undergone radiotherapy, cryotherapy, or other local treatments; e. Single lesion 5 mg/L) or decreased appetite (FAACT-A/CS 12 score 5 mg/L): (1). Non-volitional weight loss >5% in the past 6 months; (2). BMI 2%. 4.General Inclusion Criteria: (1). Patients voluntarily participate in this study and sign the informed consent form;(2). Age >=18 years, male or female;(3). Able to swallow tablets normally;(4). ECOG performance status score of 0 or 1;(5). Life expectancy >= 12 weeks;(6). Major organ functions meet the following requirements (without the use of any blood components or colony-stimulating factors within 14 days): * Hematology: Absolute neutrophil count (ANC) >=1.5×10^9/L, hemoglobin (Hb) >=80 g/L, platelet count (PLT) >=50×10^9/L. * Liver Function: Total bilirubin (TBIL) =28 g/L. * Coagulation Function: International normalized ratio (INR), or prothrombin time (PT), or activated partial thromboplastin time (aPTT) =60 mL/min (calculated using the Cockcroft-Gault formula). * Urine protein =50%. g. Female patients of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to the first dose (if the urine pregnancy test result cannot be confirmed as 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, the patient must use an acceptable method of contraception starting from screening and must agree to continue its use for 120 days after the last dose of study drug; the decision to discontinue contraception after this time point should be discussed with the investigator. If a non-sterilized male patient engages in sexual activity with a female partner of childbearing potential, the patient must use effective contraception from screening until 120 days after the last dose; the decision to discontinue contraception after this time point should be discussed with the investigator. h. Subjects infected with HBV or HCV should be on antiviral therapy, and the treatments must not interfere with each other.
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 imaging (MRI) assessment during screening and prior imaging evaluations. Patients who have previously received treatment for brain or leptomeningeal metastases and have been stable for >=2 months, and who have discontinued systemic hormonal therapy (>10 mg/day prednisone or equivalent) >4 weeks prior to randomization, may participate in the study;(2) Uncontrolled tumor-related pain; (3) Thromboembolic disease, ascites, or lower limb edema within the past 6 months; (4) History of malignancy other than esophageal cancer within 5 years prior to randomization, except for malignancies with negligible risk of metastasis or death (e.g., expected 5-year overall survival >90%) and those expected to be cured after treatment, such as appropriately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative surgery, and ductal carcinoma in situ treated with non-surgical curative therapy; (5) Presence of unresolved toxicities from prior antitumor therapy, defined as not having recovered to <= Grade 1 per NCI CTCAE version 5.0 (except alopecia) or to the level specified in the inclusion/exclusion criteria. 2.General Medical Exclusion Criteria (1) Women who are pregnant, breastfeeding, or planning to become pregnant during the study; (2) In the judgment of the investigator, the patient has factors that may affect the study results or lead to premature study discontinuation, such as brain tumors, substance abuse, other serious illnesses (including psychiatric disorders) requiring concurrent treatment, significant laboratory abnormalities, or accompanying familial or social factors that may compromise patient safety;(3) Patients with a positive test result for human immunodeficiency virus (HIV); (4) Major surgery (excluding diagnostic procedures) within 28 days prior to randomization; (5) Significant cardiovascular disease, such as heart disease defined by the organizing cardiology society (Class II or higher), myocardial infarction within 3 months prior to randomization, unstable arrhythmias, unstable angina, cerebrovascular accident, or transient ischemic attack; patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction <50% must be treated with a regimen considered optimal by the treating physician, in consultation with a cardiologist if necessary; (6) Severe infection within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic anti-infective therapy within 2 weeks prior to the first dose (excluding antiviral therapy for hepatitis B or hepatitis C). 3.Medication-Related Exclusion Criteria (1) Any condition affecting gastrointestinal absorption, such as dysphagia, malabsorption, or uncontrolled vomiting; ongoing tube feeding or parenteral nutrition; presence of anorexia nervosa, anorexia due to psychiatric disorders, or pain making eating difficult.;(2) Currently using or planning to use other appetite- or weight-stimulating medications, such as: adrenal corticosteroids (except short-term use of dexamethasone during chemotherapy), androgens, progestogens, thalidomide, olanzapine, anamorelin, or other appetite stimulants;(3) Patients wit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with >5% weight loss from baseline.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment compliance;L3-SMI;Incidence and severity of adverse events (AEs);Objective Response Rate;Life quality;Overall survival;Inflammatory markers, nutritional indicators;Anxiety and depression;Progression free survival; | — |
Countries
China
Contacts
Public ContactJinzhang Chen
Southern Medical University Southern Hospital
Outcome results
None listed