Fluzopari Combined With Apatinib for the Neoadjuvant Treatment of Unresectable Ovarian Cancer

NCT05597527 | Unknown Phase 2

• 1 other identifier: HPing
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single arm, multi center, exploratory clinical study to evaluate the efficacy and safety of fluzoparide combined with alpatinib as neoadjuvant therapy in patients with BRCA1/2 gene mutation or HRD gene mutation, advanced ovarian cancer, primary peritoneal cancer, fallopian tube cancer ((FIGO stage III or IV), who can not achieve R0 tumor reduction surgery after imaging evaluation or laparoscopic evaluation .

Conditions

Ovarian Cancer

Keywords

Fluzopari; Apatinini

Outcome Measures

Primary Outcomes (2)

• R0 resection rate

  The percentage of patients received R0 resection after Fluzopari and Apatinib neoadjuvant treatment.

  3-month

• Overall Response Rate (ORR)

  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.

  3-month

Secondary Outcomes (5)

• Disease Control Rate (DCR)

  3-month

• Complete pathologic response rate(CPR)

  3-month

• Progression Free Survival (PFS)

  3-year

• Overall survival (OS)

  5 years

• Incidence rate of adverse events

  5 years

Study Arms (1)

Fluzopari and Apatinib group

EXPERIMENTAL

Fluzopari and Apatinib were used in patients with newly diagnosed ovarian cancer before any treatment. The daily dose should be strictly controlled according to the experimental design.

Drug: Fluzopari and apatinib

Interventions

Fluzopari and apatinib DRUG

Fluzopari was used as 100mg capsules orally twice a day (one time in the morning and one time in the evening), every four weeks as a cycle, a total of 3-4 cycles. Apatinib was used as 250 mg orally once a day, every 4 weeks as a cycle, 2-3 cycles in total, and stop 4 weeks before operation.

Fluzopari and Apatinib group

Eligibility Criteria

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

You may qualify if:

• Female patients aged between 18 and 75 years old;
• Patients received open surgery, laparoscopic surgery, or coarse needle aspiration biopsy and confirmed as high-grade serous or endometrioid ovarian cancer, peritoneal cancer, or fallopian tube cancer (hereinafter referred to as ovarian cancer). FIGO stage III-IV;
• BRCA1/2 gene mutation or HRD gene mutation is confirmed by testing tissue or blood samples;
• According to RECIST 1.1 standard, the patient has at least one target lesion with measurable diameter (the long diameter of CT scan for tumor lesions is ≥ 10mm, the short diameter of CT scan for lymph node lesions is ≥ 15mm, and the scanning thickness is 5mm);
• Judge the patients who cannot achieve R0 tumor reduction or cannot tolerate surgery. The criteria for failing to achieve R0 tumor reduction include but are not limited to:
• (1) Fagotti score ≥ 8; (2) When the laparoscopic evaluation method is difficult to implement, the upper abdomen CT score is ≥ 3 (SUDANCT score);
• The criteria for surgical intolerance are as follows:
• (3) Body mass index: BMI ≥ 40.0; (4) Various chronic diseases; (5) Malnutrition or hypoproteinemia; (6) Moderate to massive ascites; 6. ECOG PS 0-1 point; 7. The main organs function normally and meet the following standards:
• The blood routine examination standard shall meet: (no blood transfusion within 14 days)
• HB≥100g/L，
• WBC≥3 × 109/L
• ANC≥1.5 × 109/L，
• PLT≥100 × 109/L；
• Biochemical examination shall meet the following standards:
• BIL ≤ 1.5 times the upper limit of normal value (ULN);

You may not qualify if:

• Other clinical drug experiments in which other experimental research drugs are used together with the study;
• In addition to this study, use other cancer neoadjuvant therapies, including but not limited to chemotherapy, radiotherapy, targeted therapy, immunotherapy, microbial therapy, traditional Chinese medicine therapy and other experimental treatments;
• Patients known to be allergic to fluzoparide or allergic to active or non active components of fluzoparide with similar chemical structure;
• Patients known to be allergic to appatinib or allergic to active or inactive components of drugs with similar chemical structure to appatinib;
• It is impossible to swallow the oral drug and any gastrointestinal disease that may interfere with the absorption and metabolism of the study drug, such as uncontrollable nausea and vomiting, gastrointestinal obstruction or malabsorption;
• Have used known or possible PARP inhibitors and anti vascular production inhibitors in the past;
• Symptomatic or uncontrolled brain metastasis requiring simultaneous treatment, including but not limited to surgery, radiotherapy and/or corticosteroids, or clinical manifestations of spinal cord compression;
• Subjects suffered from other malignant diseases in the past 3 years, except skin squamous cell carcinoma, basal like carcinoma, breast intraductal carcinoma in situ or cervical carcinoma in situ;
• The patient was previously or currently diagnosed as myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
• Recently (within 3 months), there has been intestinal obstruction and gastrointestinal perforation;
• There are clinical cardiac symptoms or diseases that are not well controlled, such as: (1) NYHA level 2 or above cardiac insufficiency (2) unstable angina pectoris (3) acute myocardial infarction within one year (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention (5) QTc\>470ms;
• Any bleeding event with a severe grade of 2 or above in CTCAE 5.0 occurred within 4 weeks before the first trial medication;
• People with hypertension who can not be well controlled after antihypertensive drug treatment (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg);
• Idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, organized pneumonia, drug pneumonia, or active pneumonia shown on CT during screening period have been or are currently present;
• Those with abnormal coagulation function (INR \> 1.5 or prothrombin time (PT) \> ULN+4s), who have bleeding tendency or are receiving thrombolytic or anticoagulant treatment (including but not limited to patients requiring long-term anticoagulant treatment), are allowed to receive low dose low molecular weight heparin or oral aspirin preventive anticoagulant treatment during the trial;

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

apatinib

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

Study Officials

• Lin An

  Fujian Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin An

CONTACT

13805015679; Linan640906@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: October 28, 2022
• Study Start: November 1, 2022
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)