Chemotherapy Combined With Propranolol Hydrochloride as Neoadjuvant Therapy for Advanced High-grade Serous Ovarian Cancer: A Prospective, Multicenter, Phase II Clinical Study
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. Cytoreductive Surgery (CRS) combined with chemotherapy is the standard treatment for patients with advanced ovarian cancer. However, most of the ovarian cancer is stage Ⅲ and above, and there may be a certain degree of organ metastasis. Preclinical studies have found that the stress of melanoma block beta adrenergic signals in mice, which USES beta blockers, checkpoint will enhance resistance to PD - 1 the activity of the inhibitor, to improve the treatment of mice on the immune response. Non-selective β-blockers can also improve the efficacy of melanoma immunotherapy. Retrospective studies have shown that incidental use of β-blockers in combination with antiangiogenic agents, chemotherapy, and immune therapy can prolong DFS, PFS, and OS in cancer patients. A large, multicenter retrospective study found that ovarian cancer patients who took nonselective β-blockers for hypertension had better survival than those who did not. In conclusion, this study aims to explore new auxiliary chemotherapy combined propranolol treatment of high efficacy and safety of ovarian cancer, provide more evidence-based basis for clinic.
• 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