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New treatment option for Advanced Pancreatic Ductal Adenocarcinoma
Official title Nano-Megestrol Acetate for Cancer Cachexia in Advanced Pancreatic Cancer
ClinicalTrials.gov ID: NCT07408505
What this study is testing
What is Nano-crystalline megestrol acetate?
Nano-crystalline megestrol acetate is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for advanced pancreatic ductal adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Time commitment: about 12 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients must meet all of the following criteria to be eligible for enrollment: 1\. Pancreatic cancer-specific
- Histologically or cytologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma according to the TNM staging system of the...
- No prior systemic antitumor therapy for recurrent or metastatic disease;
- Prior adjuvant or neoadjuvant chemotherapy, radiotherapy, chemoradiotherapy, or immunotherapy for non-metastatic disease is allowed, provided that at...
- At least one measurable lesion according to RECIST version 1.1 (previously irradiated lesions may be considered measurable only if there is clear...
You likely can't join if
- Patients meeting any of the following criteria will be excluded from this study: 1\. Cancer-specific exclusion criteria:
- Active or untreated CNS metastases (e.g., brain or leptomeningeal metastases) as determined by CT or magnetic resonance imaging (MRI) during...
- Uncontrolled tumor-related pain; (1) History of thromboembolic disease, ascites, or lower extremity edema within the past 6 months; (3) History of...
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;
- Patients with hepatitis B or hepatitis C: ① Patients with a history of hepatitis B virus (HBV) infection must undergo HBV deoxyribonucleic acid (DNA)...
- Patients with a positive test result for human immunodeficiency virus (HIV);
See the full eligibility criteria
Who can join
- Patients must meet all of the following criteria to be eligible for enrollment: 1\. Pancreatic cancer-specific
- Histologically or cytologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma according to the TNM staging system of the International Association of Pancreatology and the 8th edition of the...
- No prior systemic antitumor therapy for recurrent or metastatic disease;
- Prior adjuvant or neoadjuvant chemotherapy, radiotherapy, chemoradiotherapy, or immunotherapy for non-metastatic disease is allowed, provided that at least 6 months have elapsed since completion of the last treatment...
- At least one measurable lesion according to RECIST version 1.1 (previously irradiated lesions may be considered measurable only if there is clear evidence of disease progression after radiotherapy). 2\. Fulfillment of...
- Body weight loss \> 2% in patients with a BMI \< 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...
- Systemic inflammation (CRP \> 5 mg/L); ③ Decreased appetite (FAACT-A/CS 12 score ≤ 37). 3. General
- Good compliance and provision of written informed consent;
- Age 18-75 years, regardless of sex;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- Expected survival greater than 4 months;
- Adequate organ function, defined as follows:
- Hematologic function: absolute neutrophil count ≥ 1.5 × 10⁹/L, hemoglobin ≥ 9 g/dL, platelet count ≥ 100 × 10⁹/L;
- Hepatic function: total bilirubin ≤ 1.5 × upper limit of normal (ULN) (patients with known Gilbert's syndrome may be enrolled if serum bilirubin ≤ 3 × ULN), AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN in the presence of liver...
- Coagulation function: international normalized ratio (INR), prothrombin time (PT), or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN;
- Renal function: creatinine clearance ≥ 60 mL/min as calculated by the Cockcroft-Gault formula;
- Urinary protein: urine protein ≤ 1+ on dipstick or 24-hour urine protein \< 1.0 g;
- Cardiac function: left ventricular ejection fraction (LVEF) ≥ 50%.
- Women of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to first dosing (if a urine pregnancy test cannot be confirmed as negative, a serum pregnancy test is required and...
What rules you out
- Patients meeting any of the following criteria will be excluded from this study: 1\. Cancer-specific exclusion criteria:
- Active or untreated CNS metastases (e.g., brain or leptomeningeal metastases) as determined by CT or magnetic resonance imaging (MRI) during screening or based on prior imaging assessments. Patients with previously...
- Uncontrolled tumor-related pain; (1) History of thromboembolic disease, ascites, or lower extremity edema within the past 6 months; (3) History of malignancy other than pancreatic cancer within 5 years prior to...
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;
- Patients with hepatitis B or hepatitis C: 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...
- Patients with a positive test result for human immunodeficiency virus (HIV);
- Major surgery (excluding diagnostic procedures) within 28 days prior to randomization, or anticipated major surgery during the study period;
- Significant cardiovascular disease, such as heart disease defined as New York Heart Association class II or higher, myocardial infarction within 3 months prior to randomization, unstable arrhythmia, unstable angina...
- Severe infection occurring within 4 weeks prior to first dosing, including but not limited to infections with complications requiring hospitalization, sepsis, or severe pneumonia; or active infection requiring systemic...
- Conditions affecting gastrointestinal absorption, including dysphagia, malabsorption, or uncontrolled vomiting; difficulty in food intake or requirement for tube feeding or parenteral nutrition; anorexia nervosa...
- Current or planned use of other medications that increase appetite or body weight, such as corticosteroids (except short-term dexamethasone use during chemotherapy), androgens, progestins, thalidomide, olanzapine...
- Cushing's syndrome, adrenal or pituitary insufficiency; poorly controlled diabetes mellitus; or current hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg despite treatment with...
- History within 6 months prior to first dosing of esophageal or gastric varices, severe ulcer disease, gastrointestinal perforation and/or fistula, gastrointestinal obstruction (including incomplete obstruction requiring...
- Known hypersensitivity to any component of the study drug;
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.