Evaluating Nano-Crystalline Megestrol Acetate for Cachexia in Advanced Digestive Tumors
Official title: A Multicenter, Real-World Study on Nano-Crystalline Megestrol Acetate for Cachexia in Patients With Advanced Digestive System Tumors Receiving TKI-Based Therapy
Run by Changchun GeneScience Pharmaceutical Co., Ltd. · NCT06940102 · Data updated 2026-11-12
This study is testing if a new form of Megestrol Acetate can help adults with advanced digestive tumors gain weight and feel better while they are on cancer treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Changchun GeneScience Pharmaceutical Co., Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 2 sites (Shenyang, Liaoning and 1 other locations) |
| Status | Recruiting |
| Started | March 12, 2025 |
| Main results expected | March 2026 |
| Study ends | December 2026 |
| Registry record updated | April 23, 2025 |
| Trial ID | NCT06940102 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with advanced digestive system tumors experiencing cachexia and receiving TKI-based therapy.
✕Probably not a fit
Patients with gastrointestinal obstruction or those whose anorexia is caused by mental illness or severe comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the effectiveness of Nano-Crystalline Megestrol Acetate in treating cachexia among patients with advanced digestive system tumors who are undergoing TKI-based therapy. Participants will be monitored for their response to the treatment, focusing on improvements in weight and overall health. The study will include adults aged 18 and older with specific cancer diagnoses and performance status. It seeks to gather real-world data on the impact of this treatment approach.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life and nutritional status of patients suffering from cachexia due to advanced digestive tumors.
How similar studies have gone: While there is limited data on this specific approach, similar studies using Megestrol Acetate for cachexia have shown promise, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
General Hospital of Northern Theater Command
Shenyang, Liaoning, China Recruiting -
Liaoning Cancer Hospital
Shenyang, Liaoning, China Recruiting
Study contacts
- Principal investigator: Cheng Du — The General Hospital of Northern Theater Command
- Study coordinator: Cheng Du
- Email: dc1115010@sina.com
- Phone: 024-28851942
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.