CachexiaNCT06940102
Real-World Study on Nano-Crystalline Megestrol Acetate for Cachexia in TKI-Treated Advanced Digestive Tumors
An observational study of Cachexia and Digestive System Cancer, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cachexia, Digestive System Cancer, Gastric Cancer
- What is being tested?
- Nano-crystalline Megestrol Acetate Oral Suspension and TKI-Based Therapy
- Type of treatment
- Pill or oral medicine
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- 12 Mar 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with locally advanced or metastatic digestive system tumors
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
General Hospital of Northern Theater Command
Shenyang, Liaoning, 110016
- Recruiting
Liaoning Cancer Hospital
Shenyang, Liaoning, 110042
About this study
Official title: 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.
- Conditions
- Cachexia, Digestive System Cancer, Gastric Cancer, Colorectal Cancer, Hepatocellular Carcinoma
- Being tested
- Nano-crystalline Megestrol Acetate Oral Suspension, TKI-Based Therapy
- Keywords
- Megestrol Acetate, Nano-crystalline Megestrol Acetate, Targeted Therapy, Tyrosine Kinase Inhibitors, Prospective Studies, Observational Studies, Antineoplastic Agents, Digestive System Cancer
- Medical subject headings
- Cachexia, Digestive System Neoplasms, Stomach Neoplasms, Colorectal Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nano-crystalline Megestrol Acetate Oral SuspensionDrug
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 TherapyDrug
TKI-Based Therapy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Nano-crystalline Megestrol Acetate Oral Suspension; Drug: TKI-Based Therapy | |
| TKI-Based Therapy | TKI Therapy ± chemotherapy / immunotherapy Receives: Drug: TKI-Based Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appetite improvement level
Proportion of subjects with an improvement in appetite based on A/CS-12 after 12 weeks of treatment
Measured: 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
Measured: From baseline to Week 12 (end of treatment period)
Secondary outcomes (1)
progression-free survival (PFS)
defined as the duration from the start treatment to progression, or patient death
Measured: From the date of randomization until the first documented disease progression or death from any cause, whichever occurs first，assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start12 Mar 2025
- Primary completionMar 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CachexiaStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cheng Du, Principal investigator, The General Hospital of Northern Theater CommandZhenguang Du, Principal investigator, Organizational Affiliation: Liaoning Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940102
- Sponsor's protocol ID
- MGA-DSC-601
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Real-World Study on Nano-Crystalline Megestrol Acetate for Cachexia in Patients With Advanced Digestive System Tumors Receiving TKI-Based Therapy
- ClinicalTrials.gov ID
- NCT06940102
- Acronym / sponsor ID
- MGA-DSC-601
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nano-crystalline Megestrol Acetate Oral Suspension +TKI-Based Therapy | – | Drug: Nano-crystalline Megestrol Acetate Oral Suspension, Drug: TKI-Based TherapyNano-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 |
| TKI-Based Therapy | – | Drug: TKI-Based TherapyTKI Therapy ± chemotherapy / immunotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally advanced or metastatic digestive system tumors
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nano-crystalline Megestrol Acetate Oral SuspensionNano-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 | Nano-crystalline Megestrol Acetate Oral Suspension +TKI-Based Therapy |
| TKI-Based TherapyTKI-Based Therapy | Drug | Nano-crystalline Megestrol Acetate Oral Suspension +TKI-Based Therapy, TKI-Based Therapy |
Primary outcome
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
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cheng Du principal investigator
The General Hospital of Northern Theater Command
Zhenguang Du principal investigator
Organizational Affiliation: Liaoning Cancer Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cachexia and Digestive System Cancer, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cheng Du (024-28851942, dc1115010@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appetite improvement level (time frame: From baseline to Week 12 (end of treatment period)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025; AzTrials last refreshed its copy on 31 Oct 2026.