Can a simple pill help liver cancer patients eat better?
NCT ID NCT07565415
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 2 trial tests whether a drug called nanocrystalline megestrol acetate can help people with advanced liver cancer who are losing weight and appetite. About 88 patients will receive either the drug or a placebo for 12 weeks while also getting standard cancer therapy. The goal is to see if the drug prevents weight loss and improves quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nanocrystalline megestrol acetate (a hormone-like drug to boost appetite)
- What this could lead to
- If it works, this could provide a way to help liver cancer patients maintain weight and appetite during treatment, improving quality of life.
- What could go wrong
- This is an early Phase 2 trial with only 88 participants, so results may not apply to everyone. The drug may cause side effects like fluid retention or blood clots.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 88 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with unresectable primary hepatocellular carcinoma (HCC) confirmed by imaging or histopathology * No previous receipt of immunotherapy and/or targeted drug therapy * Child-Pugh score ≤ 7 * At least one measurable lesion per RECIST 1.1 criteria; lesions without prior radiotherapy, cryotherapy or other local treatment * Single intrahepatic lesion \< 10 cm, or fewer than 10 intrahepatic lesions with tumor burden \< 50% * Meet precachexia criteria: non-volitional weight loss ≤ 5% in 6 months, plus systemic inflammation (CRP \> 5 mg/L) or decreased appetite (FAACT-A/CS-12 score ≤ 37 points) * Meet cachexia criteria: accompanied by decreased appetite or systemic inflammation, with either non-volitional weight loss \> 5% in 6 months or BMI \< 18.5 kg/m² plus weight loss \> 2% * Voluntarily participate and sign informed consent * Age ≥ 18 years, male or female * Able to swallow tablets normally * ECOG performance status 0 or 1 * Life expectancy ≥ 12 weeks * Adequate major organ function without blood products or colony-stimulating factors within 14 days * Hematology: ANC ≥ 1.5×10⁹/L, Hb ≥ 80 g/L, PLT ≥ 50×10⁹/L * Liver function: TBIL ≤ 1.5×ULN, AST/ALT ≤ 5.0×ULN, ALB ≥ 28 g/L * Coagulation function: INR, PT or aPTT ≤ 1.5×ULN * Renal function: SCr ≤ 1.5×ULN or creatinine clearance ≥ 60 mL/min * Urine protein ≤ 1+ or 24-hour urine protein \< 1.0 g * Cardiac function: LVEF ≥ 50% * Females of childbearing potential with negative pregnancy test within 3 days before first dosing * Fertile male and female patients agree to effective contraception from screening to 120 days after last study drug * HBV/HCV infected patients receive stable antiviral therapy without drug interaction Exclusion Criteria: * Active or untreated CNS metastases; inadequately controlled metastatic brain or leptomeningeal disease * Uncontrolled tumor-related pain * Thromboembolic disease, ascites or lower limb edema within 6 months * History of other malignancies within 5 years before randomization, except curable low-risk tumors * Unresolved adverse toxicities from prior antitumor therapy not recovered to ≤ Grade 1 (CTCAE v5.0), excluding alopecia * Pregnant, breastfeeding females or those planning pregnancy during the study * Any unstable medical, psychiatric or social condition that may interfere with study participation * Positive HIV infection * Major surgery within 28 days prior to randomization * Severe cardiovascular disease, myocardial infarction, unstable arrhythmia, angina or cerebrovascular events * Severe systemic infection within 4 weeks before dosing or active infection requiring systemic anti-infective treatment * Impaired gastrointestinal absorption, long-term tube feeding, parenteral nutrition or eating disorders * Concomitant use of other appetite-enhancing or weight-stimulating agents * Cushing's syndrome, adrenal or pituitary insufficiency, poorly controlled diabetes * Uncontrolled hypertension despite oral antihypertensive treatment * Esophagogastric varices, severe ulcers, gastrointestinal bleeding, obstruction, perforation or fistula within 6 months * Known hypersensitivity to any component of the investigational product * Any other condition considered inappropriate for enrollment by the investigator.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
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