Real-World Study on Nano-Crystalline Megestrol Acetate for Cachexia in TKI-Treated Advanced Digestive Tumors

Recruiting

• Conditions: Cachexia; Digestive System Cancer; Gastric Cancer; Colorectal Cancer; Hepatocellular Carcinoma
• Interventions: Drug: Nano-crystalline Megestrol Acetate Oral Suspension; Drug: TKI-Based Therapy

• Registration Number: NCT06940102
• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-12
• Study First Submitted: 2025-03-26
• Study First Submitted QC: 2025-04-15
• Last Update Submitted: 2025-04-15
• Study First Posted: 2025-04-23
• Last Update Posted: 2025-04-23
• Primary Completion: 2026-03
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nano-crystalline Megestrol Acetate Oral Suspension +TKI-Based Therapy	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 Therapy ± chemotherapy / immunotherapy
Nano-crystalline Megestrol Acetate Oral Suspension +TKI-Based Therapy	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
TKI-Based Therapy	TKI-Based Therapy	TKI Therapy ± chemotherapy / immunotherapy

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

General Hospital of Northern Theater Command; 🇨🇳 Shenyang, Liaoning, China

Liaoning Cancer Hospital; 🇨🇳 Shenyang, Liaoning, China