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New treatment option for Ovarian Cancer
Official title Chemotherapy Combined With Propranolol Hydrochloride as Neoadjuvant Therapy for Advanced High-grade Serous Ovarian Cancer
ClinicalTrials.gov ID: NCT07125391
What this study is testing
What is Propranolol Hydrochloride?
Propranolol Hydrochloride is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for ovarian 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
- Ovarian Cancer (OC) is one of the most common gynecological malignant tumors. In recent years, the incidence of ovarian cancer in China has been on the rise, but its mortality ranks the first among gynecological tumors.
- Phase 2: a mid-size study of how well it works
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, women only
You may be able to join if
- Written informed consent was obtained before any trial-related procedures were performed.
- Women, 18 to 75 years old;
- FIGO stage for stage III or IV, including not surgery in patients with stage III or IV beginning for ovarian cancer; Histopathology confirmed...
- According to the response evaluation criteria in 1.1 (RECIST1.1) definition, patients must have a measurable lesions
- Agreed to provide the participants formalin fixed and tumor tissue specimens or fresh biopsy tissue tumor lesions markers detection
You likely can't join if
- Malignant diseases other than ovarian cancer (excluding radical skin basal cell carcinoma, skin squamous cell carcinoma, and/or radical resection in...
- Current are participating in clinical research and treatment of intrusive, or within 4 weeks before the first dose received study used drugs or other...
- Always received pelvic radiotherapy and systemic chemotherapy for ovarian cancer, tumor targeting therapy, immune therapy
- Need treatment of symptomatic or non-control brain metastasis at the same time, including but not limited to, surgery, radiation and/or...
- Current use of oral or intravenous beta blockers (atenolol, peso parlour, carvedilol and labetalol, metoprolol, than the parlour, his law such as...
- Patients who have previously used propranolol, particularly those who were still on continuous use or had discontinued the medication for less than...
See the full eligibility criteria
- Written informed consent was obtained before any trial-related procedures were performed.
- Women, 18 to 75 years old;
- FIGO stage for stage III or IV, including not surgery in patients with stage III or IV beginning for ovarian cancer; Histopathology confirmed high-grade serous ovarian cancer.
- According to the response evaluation criteria in 1.1 (RECIST1.1) definition, patients must have a measurable lesions
- Agreed to provide the participants formalin fixed and tumor tissue specimens or fresh biopsy tissue tumor lesions markers detection
- ECOG score 0-1 points
- Expected survival time 6 months or more
- Enough organ function, without severe hematopoietic dysfunction and heart, lung, liver, kidney dysfunction, and immune deficiency, participants need to satisfy the following laboratory indicators
- hemoglobin (HGB) 90 g/L or higher
- Neutrophils (NEUT) acuity 1.5 x 109 / L or white blood cell count (WBC) or 3 x 109 / L
- Platelet (PLT) or 90 x 109 / L
- Nmda aminotransferase (AST) 2.5 x ULN or less
- Alanine aminotransferase (ALT) 2.5 x ULN or less
- Total bilirubin (TBIL) 1.5 x ULN or less
- Serum creatinine (SCr) 1.0 x ULN or less
- Potential fertility women in the group of 7 days before the serum or urine HCG were negative (postmenopausal women considered must be at least 12 months of amenorrhea fertility; Pregnancy tests are not required for...
- Potential fertility women are willing to take in the experiment of the medical contraception
- Malignant diseases other than ovarian cancer (excluding radical skin basal cell carcinoma, skin squamous cell carcinoma, and/or radical resection in situ carcinoma) diagnosed within 5 years before the first dose
- Current are participating in clinical research and treatment of intrusive, or within 4 weeks before the first dose received study used drugs or other treatments
- Always received pelvic radiotherapy and systemic chemotherapy for ovarian cancer, tumor targeting therapy, immune therapy
- Need treatment of symptomatic or non-control brain metastasis at the same time, including but not limited to, surgery, radiation and/or corticosteroids, or with the clinical manifestations of spinal cord compression
- Current use of oral or intravenous beta blockers (atenolol, peso parlour, carvedilol and labetalol, metoprolol, than the parlour, his law such as beta blockers) cannot safely use of propranolol
- Patients who have previously used propranolol, particularly those who were still on continuous use or had discontinued the medication for less than 14 days within 14 days prior to enrollment, are ineligible for...
- Patients with contraindications to β-blockers were excluded according to the contraindications in the propranolol package insert.
- Patients were receiving systemic glucocorticoids (excluding topical glucocorticoids by nasal spray, inhalation, or other route) or any other form of immunosuppressive therapy within 7 days before the first study dose...
- Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation
- Patients who were allergic to the active ingredient or excipients of propranolol hydrochloride in this study
- Have not fully recovered from any intervention-related toxicity and/or complications before starting treatment (i.e., ≤ grade 1 or baseline, excluding fatigue or alopecia)
- Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive)
- Hepatitis b patients with known
- Activity of HCV infection people (HCV antibody positive and HCV - RNA levels higher than the detection limit)
- For the first time to give medicine before (1 cycle, day 1) vaccinated live vaccine within 30 days
- Pregnant or lactating women
- Any serious or uncontrolled systemic disease, such as
- resting electrocardiogram (ecg) in rhythm, conduction, or have a significant and severe symptoms to appear on the form is hard to control the exceptions, such as complete left bundle branch block, Ⅱ degrees above heart...
- Unstable angina and congestive heart failure, New York heart association (NYHA) classification of grade 2 or more chronic heart failure
- Within 6 months before the selected treatment had any arterial thrombosis, embolism, or ischemia, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, etc.
- First dose exist within 1 year before need to glucocorticoid treatment of infectious pneumonia history, or the current clinical activity interstitial lung disease; Active tuberculosis
- There need systemic treatment of active or failure to control the infection
- Clinical activity diverticulitis, abdominal abscess, gastrointestinal obstruction
- Liver disease such as cirrhosis of the liver, decompensated liver disease, acute or chronic active hepatitis
- Mental disorders and unable to cooperate with treatment
- Any medical history or evidence of illness, abnormal treatment or laboratory values, or other conditions that might interfere with the results of the trial or prevent full participation in the study, or any other...
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, 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.