Real-World Study on Nano-Crystalline Megestrol Acetate for Cachexia in TKI-Treated Advance
This study is a prospective, observational clinical study aimed at evaluating the efficacy of Megestrol Acetate for cachexia in patients with advanced digestive system tumors receiving TKI-based therapy.
| Condition(s) | Cachexia, Digestive System Cancer, Gastric Cancer, Colorectal Cancer, Hepatocellular Carcinoma |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | This study is a prospective, observational clinical study aimed at evaluating the efficacy of Megestrol Acetate for cachexia in patients with advanced digestive system tumors receiving TKI-based therapy. |
| Who can participate | Inclusion Criteria: * Voluntarily sign a written informed consent (ICF). * Age ≥ 18 years at enrollment. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. * Life expectancy ≥ 3 months. * Histologically or cytologically confirmed locally advanced or metastatic digestive system tumors that are not amenable to curative treatment, according to the 8th edition TNM staging classification. * Not benefiting from local anticancer therapies such as surgery, local ablation, or chemoembolization, and planned to receive TKI-based anticancer treatment, which may be combined with chemotherapy or immunotherapy). * Meet the diagnostic criteria for pre-cachexia or cachexia (based on Fearon diagnostic criteria). * Good organ function determined Exclusion Criteria: * Gastrointestinal obst |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Changchun GeneScience Pharmaceutical Co., Ltd. |
| Locations | Shenyang, Liaoning, China; Shenyang, Liaoning, China |
| Start date | 2025-03-12 |
| NCT ID | NCT06940102 |
| Official listing | https://clinicaltrials.gov/study/NCT06940102 |