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Real-World Study on Nano-Crystalline Megestrol Acetate for Cachexia in TKI-Treated Advanced Digestive Tumors
RECRUITINGSponsored by Changchun GeneScience Pharmaceutical Co., Ltd.
Actively Recruiting
SponsorChangchun GeneScience Pharmaceutical Co., Ltd.
Started2025-03-12
Est. completion2026-03
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06940102
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
Age: 18 Years+Healthy volunteers accepted
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.
Conditions9
CachexiaCancerColorectal CancerDigestive System CancerGastric CancerHepatocellular CarcinomaLiver CancerLiver DiseaseWeight Loss
Interventions2
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Actively Recruiting
SponsorChangchun GeneScience Pharmaceutical Co., Ltd.
Started2025-03-12
Est. completion2026-03
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06940102