Ovarian CancerPhase 2NCT07125391
Chemotherapy Combined With Propranolol Hydrochloride as Neoadjuvant Therapy for Advanced High-grade Serous Ovarian Cancer
A Phase 2 study testing Propranolol Hydrochloride, Paclitaxel liposome and Carboplatin in people with Ovarian Cancer, run by Bai-Rong Xia at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Propranolol Hydrochloride, Paclitaxel liposome and Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2025to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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 inclusion. Those who have discontinued the medication for ≥14 days and meet the safety criteria as determined by the investigator may be selected for enrollment.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Anhui Cancer Hospitail
Hefei, Anhui, 230001
Bai-Rong Xia, Doctor, +8118604516165, xiabairong9999@126.com
xiabairong9999@126.com
About this study
Official title: 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.
Read the 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, 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) were administered as neoadjuvant therapy for a total of 3 cycles, followed by intermittent debulking surgery (IDS). Propranolol hydrochloride was initiated upon definitive pathology 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. Queue B receive paclitaxel liposome (135-175 mg/m2, d1, Q3W) and carboplatin (AUC = 4-5, d1, Q3W), neoadjuvant therapy cycle, a total of 3 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
- Being tested
- Propranolol Hydrochloride, Paclitaxel liposome, Carboplatin
- Keywords
- NACT
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propranolol HydrochlorideDrug
propranolol hydrochloride (20mg, BID, QD)
Paclitaxel liposomeDrug
(135-175mg/m2, d1, Q3W)
CarboplatinDrug
AUC=4-5, d1, Q3W
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Drug: Propranolol Hydrochloride; Drug: Paclitaxel liposome; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRS
Chemotherapy Response Scoring：Pathological assessment was conducted on the retinal tissue removed during the surgery
Measured: 3-month
Secondary outcomes (5)
R0 resection rate
the percentage of patients received R0 resection after neoadjuvant therapy
Measured: 3-month
Overall Response Rate (ORR) After Neoadjuvant treatment
Overall Response Rate according to RECIST1.1 after Neoadjuvant treatment. ORR is defined as the proportion of participants achieving Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST (v.1.1). Per RECIST 1.1, CR is defined as the disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of diameters (SoD) of target lesions
Measured: 3-month
Pathological complete remission rate
No residual invasive carcinoma was found under the microscope, but ductal carcinoma in situ could be found; In addition, compare the amount of cancer cells in the specimen before and after the new adjuvant therapy, and use of the Miller Payne grading system to evaluate the effect of the new adjuvant therapy
Measured: 3-month
12-month disease-free survival rate
The rate of patients who did not have any event from the beginning of enrollment to 12 months, including disease progression, inoperable, local or remote recurrence, and death from any cause
Measured: 12 months
12-month survival rate
Rate of patients who did not have a death event from enrollment to 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start20 Jun 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bai-Rong Xia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bai-Rong Xia, Anhui Provincial Cancer Hospital
- Investigators
- Bai-Rong Xia, Doctor, Study chair, Anhui Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125391
- Sponsor's protocol ID
- 2025-LLYJ-0015
- Status last verified
- Jun 2026
- First submitted
- 9 Aug 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy Combined With Propranolol Hydrochloride as Neoadjuvant Therapy for Advanced High-grade Serous Ovarian Cancer: A Prospective, Multicenter, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT07125391
- Acronym / sponsor ID
- 2025-LLYJ-0015
- Conditions
- Ovarian Cancer
- Keywords
- NACT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Bai-Rong XiaUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, 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) were administered as neoadjuvant therapy for a total of 3 cycles, followed by intermittent debulking surgery (IDS). Propranolol hydrochloride was initiated upon definitive pathology 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. Queue B receive paclitaxel liposome (135-175 mg/m2, d1, Q3W) and carboplatin (AUC = 4-5, d1, Q3W), neoadjuvant therapy cycle, a total of 3 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Paclitaxel liposome, Drug: CarboplatinAdhere 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). |
| experimental group | Experimental | Drug: Propranolol Hydrochloride, Drug: Paclitaxel liposome, Drug: CarboplatinThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propranolol Hydrochloridepropranolol hydrochloride (20mg, BID, QD) | Drug | experimental group |
| Paclitaxel liposome(135-175mg/m2, d1, Q3W) | Drug | Control group, experimental group |
| CarboplatinAUC=4-5, d1, Q3W | Drug | Control group, experimental group |
Primary outcome
CRS
Time frame: 3-month
Chemotherapy Response Scoring：Pathological assessment was conducted on the retinal tissue removed during the surgery
5 secondary outcomes
R0 resection rate
Time frame: 3-month
Overall Response Rate (ORR) After Neoadjuvant treatment
Time frame: 3-month
Pathological complete remission rate
Time frame: 3-month
12-month disease-free survival rate
Time frame: 12 months
12-month survival rate
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bai-Rong Xia, Doctor study chair
Anhui Provincial Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Propranolol Hydrochloride, Paclitaxel liposome and Carboplatin in people with Ovarian Cancer, run by Bai-Rong Xia at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yao Xia, Doctor (+8118604516165, xiabairong9999@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRS (time frame: 3-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.