Real-World Study on Nano-Crystalline Megestrol Acetate for Cachexia in TKI-Treated Advanced Digestive Tumors
Recruiting · NCT06940102 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Nano-crystalline Megestrol Acetate Oral SuspensionTKI-Based Therapy
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
2 locations listed.
- General Hospital of Northern Theater Command - Shenyang, Liaoning, China
- Liaoning Cancer Hospital - Shenyang, Liaoning, China