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

NCT07125391 | Recruiting Phase 2

• 1 other identifier: 2025-LLYJ-0015
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer

Keywords

NACT

Outcome Measures

Primary Outcomes (1)

• CRS

  Chemotherapy Response Scoring：Pathological assessment was conducted on the retinal tissue removed during the surgery

  3-month

Secondary Outcomes (5)

• R0 resection rate

  3-month

• Overall Response Rate (ORR) After Neoadjuvant treatment

  3-month

• Pathological complete remission rate

  3-month

• 12-month disease-free survival rate

  12 months

• 12-month survival rate

  12 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

Adhere to neoadjuvant therapy with paclitaxel liposomes (135-175 mg/m², day 1, every 3 weeks) and carboplatin (AUC = 4-5, day 1, every 3 weeks) for a total of 3 cycles, followed by intermittent debulking surgery (IDS).

Drug: Paclitaxel liposome; Drug: Carboplatin

experimental group

EXPERIMENTAL

The patients received propranolol hydrochloride (20 mg, twice daily), paclitaxel liposomes (135-175 mg/m² on day 1, every 3 weeks), and carboplatin (AUC = 4-5 on day 1, every 3 weeks) as neoadjuvant therapy for a total of 3 cycles, followed by intermittent debulking surgery (IDS). Propranolol hydrochloride was administered starting after definitive pathology confirmation and continued until day 14 of the third cycle, with subsequent dose reductions: first by 50% for at least 3 days, then by another 25% for at least 3 days, before complete discontinuation.

Drug: Propranolol Hydrochloride; Drug: Paclitaxel liposome; Drug: Carboplatin

Interventions

Propranolol Hydrochloride DRUG

propranolol hydrochloride (20mg, BID, QD)

experimental group

Paclitaxel liposome DRUG

(135-175mg/m2, d1, Q3W)

Control group; experimental group

Carboplatin DRUG

AUC=4-5, d1, Q3W

Control group; experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bai-Rong Xia: lead

Study Sites (1)

Anhui Cancer Hospitail

Hefei, Anhui, 230001, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Propranolol; Carboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Coordination Complexes

Study Officials

• Bai-Rong Xia, Doctor

  Anhui Provincial Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Yao Xia, Doctor

CONTACT

+8118604516165; xiabairong9999@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chairman of Department of Gynaecology Surgery

Model Details: Subjects who met the inclusion and exclusion criteria were divided into 2 groups: Cohort A received propranolol hydrochloride (20mg, BID, QD), paclitaxel liposome (135-175mg/m2, d1, Q3W), carboplatin (AUC=4-5, d1, Q3W) for 3 cycles of neoadjuvant therapy. Subsequently, interval debulking surgery (IDS) was performed. Propranolol hydrochloride should be administered starting after a definitive pathological diagnosis and continued until day 14 of the third treatment course, at which point discontinuation is indicated (initial dose reduction by 50% for at least 3 days, followed by a further reduction of 25% for at least 3 days, after which propranolol should be completely discontinued). Cohort B received neoadjuvant paclitaxel liposome (135-175mg/m2, d1, Q3W) and carboplatin (AUC=4-5, d1, Q3W) for 3 cycles, followed by interval debulking surgery (IDS).

Study Record Dates

• First Submitted: August 9, 2025
• First Posted: August 15, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

CN (1)