RecruitingNCT06940102

Real-World Study on Nano-Crystalline Megestrol Acetate for Cachexia in TKI-Treated Advanced Digestive Tumors

A Multicenter, Real-World Study on Nano-Crystalline Megestrol Acetate for Cachexia in Patients With Advanced Digestive System Tumors Receiving TKI-Based Therapy

Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Enrollment

120 participants

Start Date

Mar 12, 2025

Study Type

OBSERVATIONAL

Conditions

Gastric Cancer Digestive System Cancer Cachexia

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

Min Age: 18 Years

Inclusion Criteria8

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 Criteria6

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.