Advanced gastric esophageal cancer anorexia cachexia
Conditions
Interventions
First-line standard immune chemotherapy group:first-line standard immune chemotherapy
Nanocrystalline megestrol combined group:Nanocrystalline megestrol acetate combined with first-line standard immune chemotherapy
Sponsors
Beijing Cancer Hospital (Peking University Cancer Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Inclusion criteria for gastric and esophageal cancer: (1) Locally advanced/recurrent or metastatic esophageal squamous cell carcinoma, or adenocarcinoma of the stomach or gastroesophageal junction confirmed by histology or cytology, and gastric adenocarcinoma is HER2 negative; (2) No previous systemic anti-tumor treatment for recurrent or metastatic tumors; (3) Previous adjuvant, neoadjuvant chemotherapy/radiotherapy chemoradiotherapy/immunotherapy for non-metastatic diseases, and there is no disease recurrence for at least 6 months since the end of the last treatment; (4) According to the RECIST 1.1 criteria, there is at least one measurable lesion (only when there is clear disease progression in the previously irradiated lesion after radiotherapy, this lesion can be used as a measurable lesion). 2.Meeting the diagnostic criteria for pre-cachexia or the diagnostic criteria for the cachexia stage: (1) Diagnostic criteria for pre-cachexia, all of the following three items need to be met: 1) Unintentional weight loss within the last 6 months 5 mg/l); 3) Decreased appetite (FAACT-A/CS 12 score 5 mg/l): 1)Unintentional weight loss within the last 6 months > 5%; 2) When BMI 2%; 3.General inclusion requirements: (1) Good compliance and signed informed consent; (2) Age between 18 and 75 years old, regardless of gender; (3) ECOG score of 0-2; (4) Expected survival of more than 3 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 the Cockcroft-Gault formula); 5)Urine protein = 50% (6) Female patients of childbearing potential must undergo a urine or serum pregnancy test within 3 days before the first administration (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 is negative. If a female patient of childbearing potential has sexual intercourse with an unsterilized male partner, the patient must adopt an acceptable contraceptive method from the start of screening and must agree to continue using the contraceptive method for 120 days after the last administration of the study drug; Whether to stop contraception after this time point should be discussed with the investigator. If an unsterilized male patient has sexual intercourse with a female partner of childbearing potential, the patient must adopt an effective contraceptive method from the start of screening until 120 days after the last administ
Exclusion criteria
Exclusion criteria: 1. Cancer-Specific Exclusion Criteria: (1) Active or untreated CNS metastases identified by CT or magnetic resonance (MRI) evaluation during screening and prior imaging assessments (e.g., brain or leptomeningeal metastases). Patients who have received treatment for brain or leptomeningeal metastases and have been stable for =2 months, with systemic hormonal therapy (>10 mg/day prednisone or equivalent) discontinued >4 weeks before randomization, may be eligible. (2) Uncontrolled tumor-related pain; (3) Thromboembolic disease, ascites, or lower limb edema within the past 6 months; (4) History of malignancy other than gastroesophageal 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 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) Unresolved toxicity from prior antitumor therapy, defined as failure to recover to NCI CTCAE v5.0 grade 0 or 1 (excluding alopecia) or failure to meet the levels specified in the inclusion/exclusion criteria. 2. General Medical Exclusion Criteria: (1) Women who are pregnant, lactating, or planning to become pregnant during the study period; (2) Patients with hepatitis B (known positive HBV surface antigen [HBsAg] and HBV DNA >=1000 cps/ml or 200 IU/ml or>=upper limit of normal at each study center) or hepatitis C: 1)For patients with a history of HBV infection, HBV DNA testing must be performed, and eligibility is restricted to those with negative HBV DNA (HBV DNA <1000 cps/ml or 200 IU/ml or below the upper limit of normal); 2)Among patients with positive HCV antibody, only those with negative polymerase chain reaction (PCR) HCV ribonucleic acid (RNA) may participate in this study. (3) Patients with positive human immunodeficiency virus (HIV) test results; (4) Receipt of major surgery (excluding diagnostic surgery) within 28 days prior to randomization, or expected need for major surgery during the study period; (5) Significant cardiovascular diseases, such as heart disease defined by the New York Heart Association (class II or higher), myocardial infarction within 3 months prior to randomization, unstable arrhythmia, 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 (LVEF) <50% must receive optimal stable treatment as determined by their attending physician, with cardiology consultation if necessary. (6) Severe infection within 4 weeks prior to first dosing, including but not limited to infections with comorbidities requiring hospitalization, sepsis, or severe pneumonia; Active infection requiring systemic anti-infective therapy (excluding antiviral therapy for hepatitis B or C) within 2 weeks prior to first dosing. 3. Medication-Related Exclusion Criteria: (1) Any condition affecting gastrointestinal absorption, such as dysphagia, malabsorption, uncontrolled vomiting; Patients with difficulty ingesting food or requiring enteral or parenteral nutrition support; Anorexia nervosa, anorexia due to mental illness, or difficulty eating due to pain. (2) Current or planned use of other appetite or weight-increasing medications, such as: Adr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EORTC QLQ-C30;Weight; | — |
Secondary
| Measure | Time frame |
|---|---|
| L3-CT (Skeletal muscle);Functional Assessment of Anorexia and Cachexia (A/CS-12);Disease progression;Adverse event;Tumor Imaging; | — |
Countries
China
Contacts
Public ContactLin Shen
Beijing Cancer Hospital (Peking University Cancer Hospital)
Outcome results
None listed