A Phase 3 interventional study of Nanocrystalline Megestrol Acetate Oral Suspension and Placebo in Nasopharyngeal Cancinoma (NPC), sponsored by Sun Yat-sen University. Recruiting at 3 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Sun Yat-sen University · Phase 3, Interventional, and Treatment
Among 186 studies in Nasopharyngeal Carcinoma by Sun Yat-sen University — 80 open to participants now, 107 under way, 43 of them phase 3. Nasopharyngeal Carcinoma · Sun Yat-sen University.
Among the 186 studies in Nasopharyngeal Carcinoma by Sun Yat-sen University, this one is the 73rd largest by planned enrollment of the 161 interventional ones, is one of 14 that started in 2026, is one of 58 in phase 3, reaches primary completion later than 80 of the 106 other live ones, and was the 178th registered.
683 studies on the registry are indexed under Nasopharyngeal Carcinoma; 270 are open to participants now.
This study's planned enrollment of 204 is above the median of 100 across 557 interventional studies indexed under Nasopharyngeal Carcinoma.
Browse Nasopharyngeal Carcinoma studies →80 of the 186 studies in Nasopharyngeal Carcinoma by Sun Yat-sen University are open now, in 2 countries. Each count lists the studies.
Of the 186 Nasopharyngeal Carcinoma studies recruiting now, 42 (23%) set no upper age limit and 135 (73%) stop at 75 or younger; 9 take children under 18; 8 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →186 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 14 started in 2026.
Median enrollment 162 across the 161 interventional studies, 470 across the 25 observational. Of the 28 that completed or were terminated, 1 (4%) have results posted.
Sun Yat-sen University is the lead sponsor of 1,690 studies on the registry; 619 are open to participants now.
21 of the studies in Nasopharyngeal Carcinoma by Sun Yat-sen University that are under way reach primary completion within a year, 10 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04436965Phase 3Sun Yat-sen UniversityEffect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition | 2026-12 |
| NCT05340491Phase 3Sun Yat-sen UniversityChemoradiotherapy Plus Anti-PD1 in Recurrent NPC: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial | 2026-12 |
| NCT03907826Phase 3Sun Yat-sen UniversityPD-1 Antibody Combined With Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients | 2026-12 |
| NCT06241612Phase 3Sun Yat-sen UniversityIndividualized Elective Neck Irradiation in NPC Patients | 2026-12-31 |
| NCT06239727Phase 3Sun Yat-sen UniversityReduced-dose Radiotherapy for Stage III Nasopharyngeal Carcinoma Based on the Treatment Response | 2027-02-20 |
Among the 186 studies in Nasopharyngeal Carcinoma by Sun Yat-sen University, from their registry updates:
This phase III randomized, double-blind, placebo-controlled trial evaluates whether nanocrystalline megestrol acetate can reduce anorexia in patients with locally advanced nasopharyngeal carcinoma (NPC) undergoing concurrent chemoradiotherapy (CCRT). The study aims to confirm the clinical benefits of adding this agent to standard CCRT for improving appetite, quality of life, nutritional status, and survival outcomes.
This phase III randomized, double-blind, placebo-controlled, multicenter trial compares the efficacy and safety of nanocrystalline megestrol acetate versus placebo in prevention and management of anorexia and weight loss associated with concurrent chemoradiotherapy (CCRT) in patients with locally advanced nasopharyngeal carcinoma (NPC). Eligible patients with newly diagnosed stage II-III NPC will be randomly assigned in a 1:1 ratio to receive either nanocrystalline megestrol acetate (5ml/day) or matching placebo for 11 weeks, in combination with standard CCRT. The study aims to evaluate whether nanocrystalline megestrol acetate can significantly reduce the proportion of patients experiencing clinically significant weight loss (>5% from baseline) at day 28 post-radiotherapy, and to assess its impact on appetite, quality of life, nutritional status, and survival outcomes.
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.
Adequate organ function, defined as follows:
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.
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.
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.
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.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
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.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Nanocrystalline megestrol acetate + Concurrent chemoradiotherapy
Drug: Nanocrystalline Megestrol Acetate Oral Suspension
Placebo + Concurrent chemoradiotherapy
Drug: Placebo
Nanocrystalline megestrol acetate + Concurrent chemoradiotherapy: Nanocrystalline megestrol acetate oral suspension 625 mg (5ml) once daily orally (Week1-11) + Cisplatin 100mg/m\^2 (Day 1, 22, 43 during radiotherapy).
Placebo + Concurrent chemoradiotherapy: Placebo 5ml once daily orally (Week1-11) + Cisplatin 100mg/m\^2 (Day 1, 22, 43 during radiotherapy).
Proportion of Patients With >5% Weight Loss From Baseline at Day 28 After Completion of Radiotherapy
The proportion of patients who experience more than 5% body weight loss compared with baseline body weight, assessed at Day 28 after completion of radiotherapy.
Time frame: Day 28 after completion of radiotherapy
Change From Baseline in FAACT-A/CS12 Score
Change from baseline in anorexia/cachexia-related symptoms will be assessed using the Functional Assessment of Anorexia/Cachexia Therapy Anorexia/Cachexia Subscale (FAACT-A/CS12) to week 4, end of radiotherapy, and Day 28 after completion of radiotherapy
Time frame: 11 weeks
Proportion of Patients With >5% Weight Loss From Baseline at the End of Radiotherapy
The proportion of patients with a decrease in body weight of more than 5% from baseline body weight at the end of radiotherapy.
Time frame: 7 weeks
Percent Change in Body Weight From Baseline
Percentage change in body weight from baseline to the end of radiotherapy and day 28 after completion of radiotherapy will be calculated as \[(body weight at the prespecified assessment - baseline body weight) / baseline body weight\] × 100%.
Time frame: 11 weeks
Quality of life (QoL)
assessed using the EORTC Quality of Life Questionnaire Head and Neck Cancer Module (EORTC QLQ-H\&N35), version 1.0. Prespecified symptom scale and item scores will be calculated according to the EORTC scoring manual at baseline, week 4 of radiotherapy, end of radiotherapy, and day 28 after completion of radiotherapy.
Time frame: 11 weeks
Quality of Life (QoL)
Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), version 3.0. Prespecified functional and symptom scale scores will be calculated according to the EORTC scoring manual at baseline, week 4 of radiotherapy, end of radiotherapy, and day 28 after completion of radiotherapy.
Time frame: 11 weeks
Skeletal Muscle Index at the Third Lumbar Vertebra (L3-SMI)
Change from baseline to the end of radiotherapy in skeletal muscle index at the third lumbar vertebra (L3-SMI) will be assessed using cross-sectional imaging. L3-SMI will be calculated as the skeletal muscle cross-sectional area at the L3 level normalized to height squared (cm²/m²) .
Time frame: 7 weeks
Proportion of Patients Receiving a Prespecified Cumulative Dose of Concurrent Cisplatin
The proportion of patients receiving a cumulative concurrent cisplatin dose of at least 200 mg/m² during radiotherapy and 3 cycles of concurrent cisplatin
Time frame: 7 weeks
Incidence of Acute Toxicity
The incidence and severity of acute adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. The incidence of each adverse event will be reported separately.
Time frame: From the start of treatment to 90 days after completion of radiotherapy
Incidence of Late Radiation Toxicity
The incidence and severity of late radiation toxicities will be assessed according to the Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (RTOG/EORTC) late radiation morbidity scoring scheme.
Time frame: 90 days after completion of radiotherapy to 2 years after completion of radiotherapy
Progression-free survival
The time from randomization to any documented local or regional relapse, distant metastasis, or death from any cause, whichever occur first.
Time frame: 2 years
Overall Survival
Overall survival is defined as the time from randomization to death from any cause.
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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