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Clinical Trials in China / NCT06940102
Recruiting Observational

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

NCT06940102 · tracked via the Priya Life Science China tracker
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd
Phase
Observational
Started
2025-03-12
Last updated
2025-04-23

Condition(s) studied

CachexiaDigestive System CancerGastric CancerColorectal CancerHepatocellular Carcinoma

Investigational drug(s) / intervention(s)

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-Based Therapy: TKI-Based Therapy

Study 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

Sex
ALL
Min age
18 Years
Max age
—
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.

Primary outcome measure(s)

  • 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

Trial sites (2)

FacilityCityRegionStatus
General Hospital of Northern Theater Command Shenyang Liaoning Recruiting
Liaoning Cancer Hospital Shenyang Liaoning Recruiting

More Changchun GeneScience Pharmaceutical Co., Ltd. trials in China

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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of GenSci161 in Healthy Adult Participants Recruiting
A Clinical Study of GenSci134 in Healthy Adults and Adult Growth Hormone Deficiency(AGHD) Recruiting
A Study (Phase 1b/2) of GS3-007a Oral Treatment in Children With Growth Hormone Deficiency (PGHD) Recruiting
Nano-crystalline Megestrol Acetate for Adjuvant Treatment in High-risk Head and Neck Squamous Cell Carcinoma After Surgery. Starting soon

Other trials for the same condition

The Application Value of Spectral CT in the Accurate Staging of Colorectal Cancer Starting soon
Lenvatinib Plus Tislelizumab and CapeOX as First-Line Treatment for Advanced GC/GEJC With Positive PD-L1 and Low TMEscore Recruiting
Fruquintinib With or Without HAI-FOLFOX for Refractory Colorectal Cancer Recruiting
A Study to Evaluate C-CAR031 in Glypican-3 (GPC3)+ Advanced/Recurrent Hepatocellular Carcinoma (HCC) Active, not recruiting
Study for AZD4360 in Participants With Advanced Solid Tumours Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06940102 on ClinicalTrials.gov ↗ ← All trials in China