Chemotherapy Combined With Propranolol Hydrochloride as Neoadjuvant Therapy for Advanced High-grade Serous Ovarian Cancer

Launched by BAI-RONG XIA · Aug 9, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for women with advanced high-grade serous ovarian cancer, which is a serious form of ovarian cancer. Researchers want to see if combining standard chemotherapy with a medicine called propranolol—a drug usually used for heart conditions—can help improve treatment results and be safe to use. This study is important because ovarian cancer is often diagnosed at a late stage, and better treatment options are needed to help women live longer and feel better.

Women aged 18 to 75 with stage III or IV high-grade serous ovarian cancer who have measurable tumors may be eligible to join. Participants need to be generally healthy enough for treatment, with good organ function and no serious heart, lung, or immune problems. During the trial, women will receive chemotherapy combined with propranolol before surgery or as part of their treatment plan. The study will closely monitor their health and response to treatment. Women who are pregnant, have certain infections, other serious illnesses, or already take similar heart medications will not be able to join. This trial aims to find out if adding propranolol to chemotherapy can offer a better way to fight ovarian cancer safely.

Gender

FEMALE

Eligibility criteria

• Inclusion 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 women with documented tubal ligation)
• • Potential fertility women are willing to take in the experiment of the medical contraception
• Exclusion Criteria:
• • 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 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; Note: allows the use of physiological doses of corticosteroids (10 mg/day or less prednisone or equivalent drugs)
• • 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 subjects (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 block, ventricular arrhythmia or atrial fibrillation
• • 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 potential risk that might be considered by the investigator to be inappropriate for enrollment.