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Can a simple pill help liver cancer patients eat better?

NCT ID NCT07565415

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 88 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.