NCT07125391

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

Chemotherapy Combined With Propranolol Hydrochloride as Neoadjuvant Therapy for Advanced High-grade Serous Ovarian Cancer: A Prospective, Multicenter, Phase II Clinical Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Bai-Rong Xia · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study included patients with inoperable stage III or IV ovarian cancer who were initially treated in FIGO stage III or IV. "A phase II trial to explore the efficacy and safety of neoadjuvant chemotherapy plus propranolol in patients with histologically confirmed high-grade serous ovarian cancer." Na row standard subjects were divided into 2 groups: Queue A accept propranolol hydrochloride (20 mg, BID, QD), paclitaxel/paclitaxel liposome (135-175 mg/m2, d1, Q3W) and carboplatin (AUC = 4-5, d1, Q3W), neoadjuvant therapy cycle, A total of 3-4 Subsequently, interval debulking surgery (IDS) was performed. Propranolol hydrochloride was taken one week before neoadjuvant therapy. Queue B receive paclitaxel/paclitaxel liposome (135-175 mg/m2, d1, Q3W) and carboplatin (AUC = 4-5, d1, Q3W), neoadjuvant therapy cycle, a total of 3-4 line then intermittent tumor cells to destroy the loss (interval debulking surgery, IDS); Patients will accept the tumor assessment before the surgery, postoperative by researchers according to aid in the treatment of ovarian cancer guidelines take corresponding.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Cohort A	received propranolol hydrochloride (20mg, BID, QD), paclitaxel/paclitaxel liposome (135-175mg/m2, d1, Q3W), carboplatin (AUC=4-5, d1, Q3W) for 3-4 cycles of neoadjuvant therapy. Subsequently, interval debulking surgery (IDS) was performed. Propranolol hydrochloride was taken one week before neoadjuvant therapy

Timeline

• Start date: 2025-06-20
• Primary completion: 2026-08-30
• Completion: 2027-06-30
• First posted: 2025-08-15
• Last updated: 2025-08-15

Locations

1 site across 1 country: China