Clinical trial NCT06940102: Real-World Study on Nano-Crystalline Megestrol Acetate for Cachexia in TKI-Treated 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cachexia
Digestive System Cancer
Gastric Cancer
Colorectal Cancer
Hepatocellular Carcinoma
Keywords: Megestrol Acetate
Nano-crystalline Megestrol Acetate
Targeted Therapy
Tyrosine Kinase Inhibitors
Prospective Studies
Observational Studies
Antineoplastic Agents
Digestive System Cancer
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with locally advanced or metastatic digestive system tumors

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.


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.

Primary outcomes:
measure: Appetite improvement level
timeFrame: From baseline to Week 12 (end of treatment period)
measure: Weight improvement level
timeFrame: From baseline to Week 12 (end of treatment period)
Secondary outcomes:
measure: progression-free survival (PFS)
timeFrame: From the date of randomization until the first documented disease progression or death from any cause, whichever occurs first，assessed up to 24 months
Other outcomes:
Locations:
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
state: Liaoning
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
state: Liaoning
Study officials:
affiliation: The General Hospital of Northern Theater Command
name: Cheng Du
role: PRINCIPAL_INVESTIGATOR
affiliation: Organizational Affiliation: Liaoning Cancer Hospital
name: Zhenguang Du
role: PRINCIPAL_INVESTIGATOR
References: