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NCT Number: NCT06940102

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

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.

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Key information

Conditions

Cachexia Adenocarcinoma Body Weight Body Weight Changes Carcinoma Carcinoma, Hepatocellular Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Cancer Digestive System Diseases Digestive System Neoplasms Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Hepatocellular Carcinoma Intestinal Diseases Intestinal Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Stomach Diseases Stomach Neoplasms Thinness Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital of Northern Theater Command, Shenyang, Liaoning, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nano-crystalline Megestrol Acetate Oral Suspension

Drug

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

Drug

TKI-Based Therapy

Primary outcomes

  1. Appetite improvement level

    Time frame: 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

  2. Weight improvement level

    Time frame: 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 outcomes

  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

    defined as the duration from the start treatment to progression, or patient death

Study contacts

Contact information is provided by the study sponsor or research team.

Cheng Du

CONTACT

[email protected]

024-28851942

Zhenguang Du

CONTACT

[email protected]

17702485727

Sponsors and collaborators

Lead sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Real-World Study on Nano-Crystalline Megestrol Acetate for Cachexia in Patients With Advanced Digestive System Tumors Receiving TKI-Based Therapy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 23, 2025
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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