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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

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

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