Status:
RECRUITING
Real-World Study on Nano-Crystalline Megestrol Acetate for Cachexia in TKI-Treated Advanced Digestive Tumors
Lead Sponsor:
Changchun GeneScience Pharmaceutical Co., Ltd.
Conditions:
Cachexia
Digestive System Cancer
Eligibility:
All Genders
18+ years
Brief 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 thera...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 12 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06940102
Start Date
March 12 2025
End Date
December 1 2026
Last Update
April 23 2025
Active Locations (2)
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1
General Hospital of Northern Theater Command
Shenyang, Liaoning, China, 110016
2
Liaoning Cancer Hospital
Shenyang, Liaoning, China, 110042