Real-World Study on Nano-Crystalline Megestrol Acetate for Cachexia in TKI-Treated Advanced Digestive Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nano-crystalline Megestrol Acetate Oral Suspension, TKI-Based Therapy.
- Who it may be relevant to
- Registry conditions: Cachexia, Digestive System Cancer, Gastric Cancer, Colorectal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug 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) - Drug TKI-Based Therapy
TKI-Based Therapy
Primary outcome measures
- Appetite improvement level [Time frame: From baseline to Week 12 (end of treatment period)]
- Weight improvement level [Time frame: From baseline to Week 12 (end of treatment period)]
Secondary outcome measures (1)
- progression-free survival (PFS) [Time frame: From the date of randomization until the first documented disease progression or death from any cause, whichever occurs first，assessed up to 24 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 2 centers
- General Hospital of Northern Theater Command — Shenyang
- Liaoning Cancer Hospital — Shenyang
Identifiers
NCT: NCT06940102 · MGA-DSC-601