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New treatment option for Locally Advanced Cervical Cancer
Official title A Clinical Study of Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer
ClinicalTrials.gov ID: NCT07338487
What this study is testing
What is Nanocrystalline Megestrol Acetate Oral Suspension?
Nanocrystalline Megestrol Acetate Oral Suspension is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for locally advanced cervical cancer.
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
- Cervical cancer, ranking as the fourth most prevalent malignancy in women globally, presents significant challenges in nutritional management. Approximately 31% of patients develop cancer-related malnutrition/cachexia, with 10-20% of deaths directly attributable to nutritional depletion.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Eligibility Criteria:
- Voluntarily sign the written ICF.
- Age ≥ 18 years at the time of enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Expected survival period ≥ 6 months.
You likely can't join if
- Patients meeting any of the following criteria will be ineligible for this study:
- Conditions affecting gastrointestinal absorption such as dysphagia, malabsorption, or uncontrolled vomiting; ongoing tube feeding or parenteral...
- Current or planned use of medications that increase appetite or weight, including but not limited to: adrenal corticosteroids (except short-term...
- Diagnosis of Cushing's syndrome, adrenal or pituitary insufficiency; poorly controlled diabetes mellitus.
- Current radiographic or clinical evidence of gastrointestinal obstruction.
- Active autoimmune disease requiring systemic treatment within the past two years (e.g., disease-modifying agents, corticosteroids...
See the full eligibility criteria
- Eligibility Criteria:
- Voluntarily sign the written ICF.
- Age ≥ 18 years at the time of enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Expected survival period ≥ 6 months.
- Histologically or cytologically confirmed locally advanced cervical cancer (Stage IB3/IIA2/IIB-IVA) that is not amenable to complete surgical resection, classified according to the International Federation of Gynecology...
- Scheduled to undergo radical concurrent chemoradiotherapy.
- At least one measurable tumor lesion according to RECIST v1.1.
- Adequate organ function defined as follows: a) Hematology (without any blood component or growth factor support within 7 days prior to initiation of study treatment): i. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L...
- CrCl will be calculated using the Cockcroft-Gault formula: CrCl (mL/min) = (140 - age) × weight (kg) × F / (serum creatinine [mg/dL] × 72) F = 1 for males; F = 0.85 for females ii. Urine protein ≤ 1+ or 24-hour urinary...
- Female patients of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to the first dose (if urine pregnancy test result is not confirmed negative, a serum pregnancy test will...
- The patient is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study requirements.
- Patients meeting any of the following criteria will be ineligible for this study:
- Conditions affecting gastrointestinal absorption such as dysphagia, malabsorption, or uncontrolled vomiting; ongoing tube feeding or parenteral nutrition; presence of anorexia nervosa, psychogenic anorexia, or...
- Current or planned use of medications that increase appetite or weight, including but not limited to: adrenal corticosteroids (except short-term dexamethasone during chemotherapy), androgens, progestins, thalidomide...
- Diagnosis of Cushing's syndrome, adrenal or pituitary insufficiency; poorly controlled diabetes mellitus.
- Current radiographic or clinical evidence of gastrointestinal obstruction.
- Active autoimmune disease requiring systemic treatment within the past two years (e.g., disease-modifying agents, corticosteroids, immunosuppressants). History of non-infectious pneumonitis/interstitial lung disease...
- Uncontrolled concurrent illnesses including but not limited to decompensated cirrhosis, renal failure, uncontrolled metabolic disorders, severe active peptic ulcer disease/gastritis, or psychiatric/social conditions...
- Within 12 months prior to the first dose: unstable angina requiring hospitalization, myocardial infarction, congestive heart failure (NYHA Class II or higher), vascular disease (e.g., aortic aneurysm at risk of...
- Within 6 months prior to the first dose: any arterial thromboembolic events, Grade 3 or higher venous thromboembolism per NCI CTCAE v5.0 requiring urgent intervention (e.g., pulmonary embolism or intracardiac...
- History of severe bleeding tendency or coagulopathy; clinically significant bleeding symptoms within 1 month prior to the first dose, including but not limited to gastrointestinal bleeding, hemoptysis (defined as...
- Within 4 weeks prior to the first dose: severe infections including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; within 2 weeks prior to the first dose: active infection...
- Any condition, treatment, or laboratory abnormality that may confound study results, impede complete study participation, or make participation not in the patient's best interest.
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Hunan, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changsha, Hunan, 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.