Real-World Study on Nano-Crystalline Megestrol Acetate for Cachexia in TKI-Treated Advanced Digestive Tumors
Recruiting now
Conditions studied: Cachexia, Digestive System Cancer, Gastric Cancer, Colorectal Cancer, Hepatocellular Carcinoma
In brief
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.
Key facts
- Study ID
- NCT06940102
- Run by
- Changchun GeneScience Pharmaceutical Co., Ltd.
- People needed
- 120
- Starts
- 2025-03-12
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-04-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- General Hospital of Northern Theater Command — Shenyang, Liaoning, China (enrolling)
- Liaoning Cancer Hospital — Shenyang, Liaoning, China (enrolling)
Full record on ClinicalTrials.gov
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