An interventional study of Nano-crystalline megestrol acetate and First-line Chemotherapy in Advanced Pancreatic Ductal Adenocarcinoma and Cancer Anorexia-Cachexia Syndrome, sponsored by Shandong Cancer Hospital and Institute. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Shandong Cancer Hospital and Institute · Not applicable, Interventional, and Treatment
Cancer anorexia-cachexia syndrome is a common and severe complication in patients with advanced cancer, with a particularly high prevalence in pancreatic cancer. It is associated with systemic inflammation, metabolic disturbances, and dysregulation of central appetite control, leading to reduced quality of life, poor tolerance to anticancer therapy, and shortened survival. Anticancer treatments, including chemotherapy and immunotherapy, may further exacerbate the development and progression of cachexia.
Megestrol acetate is recommended as a first-line treatment for cancer-related anorexia-cachexia syndrome by multiple international and national guidelines, based on its proven effects on appetite stimulation, weight gain, and quality of life improvement. The nanocrystalline formulation of megestrol acetate significantly enhances bioavailability and achieves effective plasma concentrations even in the fasting state, making it particularly suitable for patients with cancer cachexia.
This randomized, controlled, prospective study aims to evaluate the efficacy and safety of nanocrystalline megestrol acetate in patients with advanced pancreatic cancer complicated by cancer anorexia-cachexia syndrome. The study will assess improvements in appetite, body weight, nutritional status, and quality of life, and explore the clinical value of early anti-cachexia intervention in the era of immuno-chemotherapy, providing evidence to optimize comprehensive treatment strategies for advanced pancreatic cancer.
This is a multicenter, randomized, controlled, prospective interventional clinical study evaluating an approved formulation of nanocrystalline megestrol acetate oral suspension. The study aims to assess the efficacy and safety of nanocrystalline megestrol acetate in combination with standard first-line therapy versus standard first-line therapy alone in newly diagnosed patients with locally advanced or metastatic pancreatic ductal adenocarcinoma with cancer anorexia-cachexia syndrome, and to explore its impact on survival outcomes, quality of life, and selected biomarkers.
Patients with pancreatic cancer have a high prevalence of malnutrition and cachexia. Treatment-related adverse effects from chemotherapy and immunotherapy may further worsen anorexia, weight loss, and skeletal muscle wasting, creating a vicious cycle that compromises treatment tolerance, quality of life, and prognosis. Although megestrol acetate is widely recommended as a first-line pharmacologic option for cancer-related anorexia-cachexia syndrome by multiple guidelines, prospective evidence regarding the optimal timing and the overall clinical benefit of combining megestrol acetate with contemporary first-line regimens (including immuno-chemotherapy) remains limited. The nanocrystalline formulation improves bioavailability through particle-size reduction and can achieve effective plasma exposure even in the fasting state, which may be particularly advantageous for patients with reduced oral intake.
Eligible participants will be stratified by pre-cachexia versus cachexia, and randomized with stratification factors including ECOG performance status (0-1 vs 2) and planned chemotherapy regimen (AG vs mFOLFIRINOX/NALIRIFOX). Participants will be assigned to one of two arms:
The primary assessment focuses on the proportion of patients achieving >5% body-weight gain from baseline at Week 12 (as a key primary endpoint within the dual-endpoint framework), along with comprehensive evaluation of appetite (FAACT-A/CS 12), body composition (L3-level CT-based assessment of skeletal muscle and adipose tissue), physical function, health-related quality of life (EORTC QLQ-C30), chemotherapy adherence, and the incidence and severity of adverse events. Tumor response will be assessed at predefined intervals (approximately every 6 weeks), and survival outcomes including overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR) will be followed and analyzed up to one year after randomization. In addition, the study will explore changes in inflammatory markers (CRP, NLR), cytokines (IL-1, IL-6, TNF-α), and nutritional indices (albumin, prealbumin, hemoglobin) from baseline to Week 12 to support mechanistic understanding and identify potential predictive biomarkers.
Safety will be monitored continuously throughout the study, with standardized collection and follow-up of adverse events (AEs) and serious adverse events (SAEs) as specified in the protocol, complemented by vital signs, physical examinations, laboratory testing, electrocardiography, and echocardiography. Overall, this study aims to validate an integrated strategy combining anticancer therapy with early anti-cachexia intervention in the immuno-chemotherapy era, and to generate high-quality evidence on the clinical value of nanocrystalline megestrol acetate in improving weight/body composition, symptom burden, quality of life, and potentially survival outcomes in advanced pancreatic cancer.
657 studies on the registry are indexed under Body Weight; 76 are open to participants now.
This study's planned enrollment of 56 is below the median of 71 across 500 interventional studies indexed under Body Weight.
Browse Body Weight studies →Shandong Cancer Hospital and Institute is the lead sponsor of 105 studies on the registry; 38 are open to participants now.
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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.
Patients must meet all of the following criteria to be eligible for enrollment:
1. Pancreatic cancer-specific inclusion criteria:
2. Fulfillment of Fearon criteria for cachexia or pre-cachexia:
(1) Cachexia stage according to Fearon criteria: fulfillment of any of the following criteria in combination with decreased appetite (FAACT-A/CS 12 score ≤ 37) or systemic inflammation (CRP > 5 mg/L):
① Unintentional weight loss > 5% within the past 6 months;
Body weight loss > 2% in patients with a \< 18.5 kg/m². (2) Pre-cachexia stage according to Fearon criteria: all of the following three conditions must be met:
① Unintentional weight loss ≤ 5% within the past 6 months;
Systemic inflammation (CRP > 5 mg/L);
③ Decreased appetite (FAACT-A/CS 12 score ≤ 37). 3. General inclusion criteria:
Adequate organ function, defined as follows:
Exclusion Criteria:
Patients meeting any of the following criteria will be excluded from this study:
1. Cancer-specific exclusion criteria:
(1) History of thromboembolic disease, ascites, or lower extremity edema within the past 6 months; (3) History of other than pancreatic cancer within 5 years prior to randomization, except for malignancies with negligible risk of or death (e.g., expected 5-year overall survival > 90%) and considered curable after appropriate treatment, such as adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer treated with curative surgery, and ductal carcinoma in situ treated with curative surgery; (4) Unresolved toxicity from prior anticancer therapy, defined as failure to recover to version 5.0 grade 0 or 1 (except alopecia) or failure to recover to levels specified in the inclusion/exclusion criteria; (5) Patients with peritoneal metastases will be excluded. 2. General medical exclusion criteria:
Patients with or :
① Patients with a history of hepatitis B virus (HBV) infection must undergo HBV deoxyribonucleic acid (DNA) testing; only patients with negative HBV DNA (HBV DNA \< 1000 copies/mL or \< 200 IU/mL or below the ) are eligible for participation in this study;
② Among patients who are positive for hepatitis C virus (HCV) antibodies, only those with negative HCV ribonucleic acid (RNA) by polymerase chain reaction (PCR) testing are eligible to participate in this study;
3. Drug-related 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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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 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.
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.
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.
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.
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.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
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.
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.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
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.
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.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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.
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.
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.
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.
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.
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.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
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.
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.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
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.
Participants assigned to the experimental arm will receive nano-crystalline megestrol acetate oral suspension in combination with first-line chemotherapy. Nano-crystalline megestrol acetate will be administered orally at a dose of 625 mg once daily (5 mL, 125 mg/mL), starting on the first day of chemotherapy and continued for up to 12 weeks. First-line chemotherapy will be selected by the investigator according to clinical guidelines and practice, including AG, FOLFIRINOX, or NALIRIFOX regimens. If the primary antitumor treatment is modified, delayed, or discontinued during the study, nano-crystalline megestrol acetate may be continued until completion of the 12-week treatment period. Patients will be followed for efficacy and safety assessments according to the study protocol.
Drug: Nano-crystalline megestrol acetate · Drug: First-line Chemotherapy
Participants assigned to the control group will receive first-line chemotherapy alone, without nano-crystalline megestrol acetate. First-line chemotherapy will be selected by the investigator according to clinical guidelines and standard clinical practice, including AG, FOLFIRINOX, or NALIRIFOX regimens. Chemotherapy dosing, schedule, and modifications will be managed according to routine clinical practice and institutional standards. Participants will be followed for efficacy and safety assessments according to the study protocol.
Drug: First-line Chemotherapy
Nano-crystalline megestrol acetate is administered as an oral suspension at a dose of 625 mg once daily (5 mL, 125 mg/mL) starting concurrently with first-line chemotherapy and continued for up to 12 weeks. Unlike conventional megestrol acetate formulations, the nano-crystalline formulation utilizes reduced particle size to enhance oral bioavailability and improve weight gain outcomes. In this study, nano-crystalline megestrol acetate is used as an early supportive intervention in treatment-naïve patients with advanced pancreatic cancer-related anorexia-cachexia syndrome, rather than as salvage therapy. The intervention is delivered in combination with standard first-line chemotherapy regimens (AG, FOLFIRINOX, or NALIRIFOX). Administration of nano-crystalline megestrol acetate may be continued even if modifications, delays, or discontinuation of chemotherapy occur, in accordance with the study protocol. Safety and efficacy are prospectively monitored throughout treatment and follow-up.
Participants in the control group will receive first-line chemotherapy alone, without nano-crystalline megestrol acetate. Chemotherapy regimens, including AG, FOLFIRINOX, or NALIRIFOX, will be selected and managed according to standard clinical practice.
Proportion of Patients Achieving >5% Weight Gain From Baseline(weight in kilograms,Kg)
The proportion of patients with advanced pancreatic cancer-related anorexia-cachexia syndrome who achieve a body weight increase of more than 5% compared with baseline(Kg) during first-line treatment combined with or without nano-crystalline megestrol acetate.
Time frame: 12 weeks
Change in Appetite Assessed by Functional Assessment of Anorexia/Cachexia Therapy-Anorexia/Cachexia Subscale (FAACT-A/CS 12)
Change from baseline in appetite as assessed by the Functional Assessment of Anorexia/Cachexia Therapy-Anorexia/Cachexia Subscale (FAACT-A/CS 12) in patients with advanced pancreatic cancer.The A/CS-12 Scale maintains the reliability, validity, and assessment accuracy of the FAACT questionnaire while reducing the number of items from 18 to 12. Each item is scored from 0 to 4, with a total score ranging from 0 to 48. Lower scores indicate poorer appetite in patients. When using the A/CS-12 Scale, it is recommended to use a total score ≤ 37 as the criterion for determining appetite loss in patients.
Time frame: 12 weeks
Change in Body Composition Assessed by L3-CT
Change from baseline in body composition parameters, including skeletal muscle and adipose tissue area, assessed by computed tomography at the third lumbar vertebra (L3) level.A single cross-sectional image of the third lumbar vertebra (L3) is obtained via CT/MRI scanning. The skeletal muscles (psoas major, erector spinae, quadratus lumborum, transversus abdominis, external oblique, internal oblique) and adipose tissue in the L3 image are identified and quantified. Image analysis software such as Slice-O-Matic or Image J is used to calculate the total skeletal muscle area(skeletal muscle area in square centimeters,cm²) at this level. This area is then divided by the square of the patient's height(height in meters,m) to obtain the L3 Skeletal Muscle Index (L3-SMI,L3-SMI =skeletal muscle area (cm²) / (height(m))².Compare the changes in Skeletal Muscle Index (SMI) from baseline to the end of the study between the two groups (Megestrol Acetate group vs. control group).
Time frame: 12 weeks
Change in Physical Function Scale
Change from baseline in physical function assessed using standardized functional assessment methods in patients with advanced pancreatic cancer.Physical Functioning Scale is assessed using a 4-point scale（from 1 to 4）, where a higher score on the functional scale indicates better function.
Time frame: 12 weeks
Change in Quality of Life Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Change from baseline in health-related quality of life assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).The Overall Quality of Life Scale is divided into 7 levels, with scores ranging from 1 to 7. Higher scores indicate better overall quality of life.
Time frame: 12 weeks
Incidence and Severity of Adverse Events
Incidence, nature, and severity of adverse events and serious adverse events assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. NCI CTCAE version 5.0 classifies the severity of adverse events into Grades 1 through 5, with a higher grade indicating greater severity. Adverse events (AEs) for each subject will be followed up until 30 days after the last dose of nanocrystalline megestrol acetate or until the initiation of new antitumor therapy, whichever occurs first. Serious adverse events (SAEs) will be followed up until 90 days after the last dose or until the initiation of new antitumor therapy, whichever occurs first. Safety assessments of the drug will be conducted according to the schedule outlined in the study protocol, including a series of examinations such as vital signs, physical examinations, clinical laboratory evaluations, electrocardiograms (ECG), and echocardiograms.
Time frame: 12 weeks
Chemotherapy Compliance
Compliance with planned first-line chemotherapy regimens, assessed by dose intensity, treatment delays, and discontinuations during the study period.
Time frame: 12 weeks
Overall Survival (OS)
The time interval from enrollment to death from any cause for patients in the intent-to-treat population. For patients who were still alive at the time of analysis or lost to follow-up, the date of the last known survival status was used as the endpoint date.
Time frame: 1 year
Progression-Free Survival (PFS)
The time interval from enrollment to disease progression or death from any cause, whichever occurs first. For patients without documented progression at the time of study discontinuation, the date of the last tumor assessment will be used as the endpoint date.
Time frame: 1 year
Overall Response Rate (ORR)
The percentage of subjects in the intent-to-treat population who achieve a complete response (CR) or partial response (PR) as their best overall response according to RECIST 1.1 criteria during the study period.
Time frame: 1 year
Disease Control Rate (DCR)
The percentage of subjects in the intent-to-treat population who achieve a best overall response of complete response (CR), partial response (PR), or stable disease (SD) lasting for at least 6 weeks, as assessed per RECIST 1.1 criteria.
Time frame: 1 year
Changes in C-reactive protein(mg/L)
Exploratory analysis of changes from baseline in inflammatory marker C-reactive protein(mg/L) between the experimental arm (first-line therapy combined with nanocrystalline megestrol acetate) and the control arm (first-line therapy alone) in the blood of patients with advanced pancreatic cancer.
Time frame: 12 weeks
Changes in neutrophil-to-lymphocyte ratio
Exploratory analysis of changes from baseline in inflammatory marker neutrophil-to-lymphocyte ratio between the experimental arm (first-line therapy combined with nanocrystalline megestrol acetate) and the control arm (first-line therapy alone) in the blood of patients with advanced pancreatic cancer.
Time frame: 12 weeks
Changes in cytokines (IL-1(pg/ml), IL-6(pg/ml), TNF-α(pg/ml))
Exploratory analysis of changes from baseline in cytokines (IL-1(pg/ml), IL-6(pg/ml) and TNF-α(pg/ml)) between the experimental arm (first-line therapy combined with nanocrystalline megestrol acetate) and the control arm (first-line therapy alone) in the blood of patients with advanced pancreatic cancer.
Time frame: 12 weeks
Changes in nutritional biomarkers (albumin(g/L), prealbumin(g/L), hemoglobin(g/L))
Exploratory analysis of changes from baseline in nutritional biomarkers (albumin(g/L), prealbumin(g/L), hemoglobin(g/L)) between the experimental arm (first-line therapy combined with nanocrystalline megestrol acetate) and the control arm (first-line therapy alone) in the blood of patients with advanced pancreatic cancer.
Time frame: 12 weeks
Plan to share: No
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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Shandong Cancer Hospital and Institute →