Actively Recruiting
A Multicenter Real-World Study on Nano-Crystalline Megestrol Acetate for Cachexia in Patients With Advanced Digestive System Tumors Receiving TKI-Based Therapy
Led by Changchun GeneScience Pharmaceutical Co., Ltd. · Updated on 2025-04-23
120
Participants Needed
2
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness of Nano-crystalline Megestrol Acetate for treating cachexia in patients with advanced digestive system tumors who are receiving TKI-based therapy. The study focuses on patients with cancers such as gastric cancer, colorectal cancer, and hepatocellular carcinoma, particularly those with advanced or metastatic disease not suitable for curative treatment. The trial is observational and conducted in a real-world setting to observe the treatment's impact. Participants will either receive Nano-crystalline Megestrol Acetate oral suspension at a dose of 625 mg per day combined with TKI therapy, which may also include chemotherapy or immunotherapy, or they will receive TKI-based therapy alone. The treatment period lasts 12 weeks, during which the effects on appetite and weight will be closely monitored. This study does not involve randomization or blinding. During the study, participants will be assessed for improvements in appetite and weight from the start to the end of the 12-week treatment period. Researchers will also track progression-free survival for up to 24 months. Assessments will include clinical evaluations and monitoring of organ function to ensure safety. The total participation time includes the 12-week treatment and extended observation for disease progression, with regular follow-up visits throughout the study duration.
CONDITIONS
Brief Title
Real-World Study on Nano-Crystalline Megestrol Acetate for Cachexia in TKI-Treated Advanced Digestive Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign a written informed consent.
- Be 18 years of age or older.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Have a life expectancy of at least 3 months.
- Have histologically or cytologically confirmed locally advanced or metastatic digestive system tumors not suitable for curative treatment.
- Not be benefiting from local anticancer therapies such as surgery, local ablation, or chemoembolization.
- Be planned to receive TKI-based anticancer treatment, which may include chemotherapy or immunotherapy.
- Meet the diagnostic criteria for pre-cachexia or cachexia based on Fearon criteria.
- Have good organ function as determined by the study team.
You will not qualify if you...
- Have gastrointestinal obstruction.
- Have anorexia caused by neurosis, mental illness, or pain affecting eating.
- Have severe cerebrovascular, cardiac, renal, or liver diseases.
- Have had major surgery or trauma within the last month.
- Have allergy to any component of the investigational drug.
- Have other conditions considered unsuitable by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive Nano-crystalline Megestrol Acetate Oral Suspension along with TKI-Based Therapy for cachexia in advanced digestive tumors.
Periodic visits during the 12-week treatment period
Duration - Up to 24 months
Participants are monitored for progression-free survival and other outcomes after the treatment period.
Follow-up visits as determined by the study team
Trial Site Locations
Total: 2 locations
1
General Hospital of Northern Theater Command
Shenyang, Liaoning, China, 110016
Actively Recruiting
2
Liaoning Cancer Hospital
Shenyang, Liaoning, China, 110042
Actively Recruiting
Research Team
C
Cheng Du
Z
Zhenguang Du
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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