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

April 15, 2025 updated by: Changchun GeneScience Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110016
        • Recruiting
        • General Hospital of Northern Theater Command
      • Shenyang, Liaoning, China, 110042
        • Recruiting
        • Liaoning Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with locally advanced or metastatic digestive system tumors

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Nano-crystalline Megestrol Acetate Oral Suspension +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
Drug: 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)
Drug: TKI-Based Therapy
TKI-Based Therapy
TKI-Based Therapy
TKI Therapy ± chemotherapy / immunotherapy
Drug: TKI-Based Therapy
TKI-Based Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From baseline to Week 12 (end of treatment period)
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
From baseline to Week 12 (end of treatment period)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From the date of randomization until the first documented disease progression or death from any cause, whichever occurs first，assessed up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Cheng Du, The General Hospital of Northern Theater Command
  • Principal Investigator: Zhenguang Du, Organizational Affiliation: Liaoning Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 26, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 23, 2025

Study Record Updates

Last Update Posted (Actual)

April 23, 2025

Last Update Submitted That Met QC Criteria

April 15, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MGA-DSC-601

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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