Real-World Study on Nano-Crystalline Megestrol Acetate for Cachexia in TKI-Treated Advanced Digestive Tumors

Launched by CHANGCHUN GENESCIENCE PHARMACEUTICAL CO., LTD. · Apr 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Megestrol Acetate on patients who are experiencing cachexia, which is a condition characterized by severe weight loss and muscle wasting, often seen in people with advanced digestive system cancers. The trial focuses on patients who are receiving a specific type of cancer treatment called TKI (tyrosine kinase inhibitors) and aims to see if Megestrol Acetate can help improve their symptoms and overall well-being.

To participate in the trial, potential volunteers must be at least 18 years old, have a confirmed diagnosis of advanced digestive tumors like gastric or colorectal cancer, and have a life expectancy of at least three months. They should also be in relatively good health, meaning they can perform daily activities with some assistance if needed. Participants will be monitored throughout the study to assess how well they respond to the medication. It's important to note that those with certain health conditions or recent surgeries may not be eligible. If you or someone you know is interested, please reach out for more details.

Gender

ALL

Eligibility criteria

• 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 obstruction.
• • Anorexia due to difficulty in eating caused by neurosis, mental illness, or pain.
• • Comorbidities such as severe cerebrovascular, cardiac, renal, or liver diseases.
• • Major surgery or trauma within the last month.
• • Allergy to any component of the investigational drug.
• • Other conditions deemed unsuitable by the investigator.