Cachexia, Colorectal Cancer, Digestive System Cancer, Gastric Cancer, Hepatocellular Carcinoma
Conditions
Keywords
Megestrol Acetate, Nano-crystalline Megestrol Acetate, Targeted Therapy, Tyrosine Kinase Inhibitors, Prospective Studies, Observational Studies, Antineoplastic Agents, Digestive System Cancer
Brief 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.
Interventions
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
Sponsors
Changchun GeneScience Pharmaceutical Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Appetite improvement level | From baseline to Week 12 (end of treatment period) | Proportion of subjects with an improvement in appetite based on A/CS-12 after 12 weeks of treatment |
| Weight improvement level | From baseline to Week 12 (end of treatment period) | Proportion of subjects who did not lose weight relative to baseline after 12 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival (PFS) | From the date of randomization until the first documented disease progression or death from any cause, whichever occurs first，assessed up to 24 months | defined as the duration from the start treatment to progression, or patient death |
Countries
China
Contacts
Primary ContactCheng Du
Backup ContactZhenguang Du
Outcome results
None listed