Nano-crystalline Megestrol Acetate Oral Suspension: Nano-crystalline Megestrol Acetate Oral Suspension, with a specification of 125 mg/mL, the study group takes 5 mL orally per day (625 mg/day)
TKI-Based Therapy: TKI-Based Therapy
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Appetite improvement level — From baseline to Week 12 (end of treatment period) Proportion of subjects with an improvement in appetite based on A/CS-12 after 12 weeks of treatment
Weight improvement level — From baseline to Week 12 (end of treatment period) Proportion of subjects who did not lose weight relative to baseline after 12 weeks of treatment
Trial sites (2)
Facility
City
Region
Status
General Hospital of Northern Theater Command
Shenyang
Liaoning
Recruiting
Liaoning Cancer Hospital
Shenyang
Liaoning
Recruiting
More Changchun GeneScience Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.