An observational study in Cachexia, Digestive System Cancer and Gastric Cancer, sponsored by Changchun GeneScience Pharmaceutical Co., Ltd.. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-23.
Sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. · Observational
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.
331 studies on the registry are indexed under Cachexia; 75 are open to participants now.
This study's planned enrollment of 120 is below the median of 150 across 88 observational studies indexed under Cachexia.
Browse Cachexia studies →Changchun GeneScience Pharmaceutical Co., Ltd. is the lead sponsor of 111 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with locally advanced or metastatic digestive system tumors
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 Therapy ± chemotherapy / immunotherapy
Drug: 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-Based Therapy
Appetite improvement level
Proportion of subjects with an improvement in appetite based on A/CS-12 after 12 weeks of treatment
Time frame: 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
Time frame: From baseline to Week 12 (end of treatment period)
progression-free survival (PFS)
defined as the duration from the start treatment to progression, or patient death
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
Started Mar 2025 (actual). Primary completion is estimated for Mar 2026, 12 months after the start.
Of 38 observational studies under Cachexia, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 48. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
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Changchun GeneScience Pharmaceutical Co., Ltd. →