Real-World Study on Nano-Crystalline Megestrol Acetate for Cachexia in TKI-Treated Advanced Digestive Tumors
NCT ID: NCT06940102
Last Updated: 2025-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2025-03-12
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Nano-crystalline Megestrol Acetate Oral Suspension +TKI-Based Therapy
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)，TKI Therapy ± chemotherapy / immunotherapy
Nano-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)
TKI-Based Therapy
TKI-Based Therapy
TKI-Based Therapy
TKI Therapy ± chemotherapy / immunotherapy
TKI-Based Therapy
TKI-Based Therapy
Interventions
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Nano-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)
TKI-Based Therapy
TKI-Based Therapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Cheng Du
Role: PRINCIPAL_INVESTIGATOR
The General Hospital of Northern Theater Command
Zhenguang Du
Role: PRINCIPAL_INVESTIGATOR
Organizational Affiliation: Liaoning Cancer Hospital
Locations
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General Hospital of Northern Theater Command
Shenyang, Liaoning, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
Countries
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Central Contacts
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Other Identifiers
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MGA-DSC-601
Identifier Type: -
Identifier Source: org_study_id
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