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

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

Plain Language Summary

Simplified for easier understanding

This study is evaluating a nano-crystalline form of megestrol acetate — a medication used to stimulate appetite and prevent weight loss — in cancer patients who are experiencing cachexia (severe unintentional weight loss and muscle wasting). The patients in this study have advanced digestive cancers and are being treated with targeted therapy drugs called TKIs (tyrosine kinase inhibitors). **You may be eligible if...** - You are 18 or older - You have confirmed advanced or metastatic digestive cancer that cannot be cured - You are planned to receive TKI-based cancer treatment - You have been diagnosed with cancer-related pre-cachexia or cachexia (significant loss of appetite and weight) - Your general health is adequate (ECOG performance status 0–2) **You may NOT be eligible if...** - You have a bowel obstruction - Your loss of appetite is due to a mental health condition, pain-related eating difficulty, or neurological issues - You have severe heart, kidney, liver, or brain disease - You had major surgery or a trauma in the past month - You are allergic to any ingredient in the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNano-crystalline Megestrol Acetate Oral Suspension

Nano-crystalline Megestrol Acetate Oral Suspension, with a specification of 125 mg/mL, the study group takes 5 mL orally per day (625 mg/day)

DRUGTKI-Based Therapy

TKI-Based Therapy


Locations(2)

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

Liaoning Cancer Hospital

Shenyang, Liaoning, China

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NCT06940102


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