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

GeneScience Pharmaceuticals (GenSci)

Status: Enrolling

Conditions: Gastric Cancer; Digestive System Cancer; Hepatocellular Carcinoma; Cachexia; Colorectal Cancer

Treatments: Drug: TKI-Based Therapy; Drug: Nano-crystalline Megestrol Acetate Oral Suspension

Study type: Observational

Funder types: Industry

Identifiers

NCT06940102

MGA-DSC-601

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

120 participants in 2 patient groups

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

Description:

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

Treatment:

Drug: Nano-crystalline Megestrol Acetate Oral Suspension

Drug: TKI-Based Therapy

TKI-Based Therapy

Description:

TKI Therapy ± chemotherapy / immunotherapy

Treatment:

Drug: TKI-Based Therapy