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

NCT06940102 | Recruiting

• 1 other identifier: MGA-DSC-601
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (2)

• Appetite improvement level

  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

  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 Outcomes (1)

• 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

Study Arms (2)

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; Drug: TKI-Based Therapy

TKI-Based Therapy

TKI Therapy ± chemotherapy / immunotherapy

Drug: TKI-Based Therapy

Interventions

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)

Nano-crystalline Megestrol Acetate Oral Suspension +TKI-Based Therapy

TKI-Based Therapy DRUG

TKI-Based Therapy

Nano-crystalline Megestrol Acetate Oral Suspension +TKI-Based Therapy; TKI-Based Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with locally advanced or metastatic digestive system tumors

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (2)

General Hospital of Northern Theater Command

Shenyang, Liaoning, 110016, China

RECRUITING

Liaoning Cancer Hospital

Shenyang, Liaoning, 110042, China

RECRUITING

MeSH Terms

Conditions

Cachexia; Digestive System Neoplasms; Stomach Neoplasms; Colorectal Neoplasms; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

• Cheng Du

  The General Hospital of Northern Theater Command

  PRINCIPAL INVESTIGATOR

• Zhenguang Du

  Organizational Affiliation: Liaoning Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheng Du

CONTACT

024-28851942; dc1115010@sina.com

Zhenguang Du

CONTACT

17702485727; d1398@lnph.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 23, 2025
• Study Start: March 12, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 23, 2025

Record last verified: 2025-03

Locations

CN (2)