Huaier Granule in Combination With Nilaparil in Therapy Patients With Stage III/IV BRCA Wild-type Ovarian Cancer

NCT05749211 | Unknown

• 1 other identifier: 2023(02)
• Study Type: interventional
• Target: 59
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-center, prospective, single-arm clinical trial to evaluate the efficacy and safety of Huaier granules in combination with immunotargeted agents in postoperative patients with ovarian cancer.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free survival (PFS)

  PFS according to the RECIST 1.1 criteria, based on the investigator's assessment.

  up to 2 years from start of treatment

Secondary Outcomes (10)

• Median Progression Free survival

  Every 3 month until 2 years from start of treatment

• 1-year progression-free survival rate

  up to 1 years

• Median overall survival

  Every 3 month until 2 years from start of treatment

• 1 year overall survival rate

  1 year

• overall survival

  From study entry to death or last contact, up to 2 years of follow-up

Study Arms (1)

Huaier granule

EXPERIMENTAL

Huaier granule is supplied as 20-g granule. Huaier granule will be administered as 20 g orally tid x 28 days (continuous). One cycle = 28 days. There is no planned treatment interruption between cycles. In the absence of intolerable toxicity, a patient may continue to receive treatment with Huaier granule until disease progression, or until 24 months have elapsed.

Drug: Huaier granule

Interventions

Huaier granule DRUG

Oral administration, 20 g once, 3 times a day, continued until progression or intolerance of toxicity

Also known as: Niraparib

Huaier granule

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• According to FIGO criteria, participants must have a histological diagnosis of high-grade serous or endometrioid carcinoma, or high-grade serous or endometrioid predominantly ovarian, fallopian tube cancer, or stage III or IV primary peritoneal carcinoma
• Inoperable stage III and IV patients; All stage III and IV patients who can accept initial or intermittent tumor reduction surgery, regardless of the residual lesion status after surgery
• Patients who had undergone abdominal chemotherapy; All participants must undergo 6 and 9 cycles of platinum-based therapy; Participants were required to receive 2 cycles of postoperative platinum therapy following interphase tumor reduction surgery; Participants had to be assessed by a physician for complete response (CR) or partial response (PR) after 3 cycles of treatment; Participants had to have cancer antigen 125 (CA-125) within the normal range or ca-125 decreased by more than 90%(%) to be stable during their first-line therapy
• All participants must agree to be tested for central tumor BRCA
• Fertile participants must have a negative serum or urine pregnancy test (human chorionic gonadotropin \[hCG\]) within 7 days of receiving the first dose of study treatment.

You may not qualify if:

• Participants had epithelial ovarian carcinosarcoma or mucinous or clear cell subtypes of undifferentiated ovarian cancer
• The participants had already undergone more than two tumor-reduction surgeries for the study disease
• Participants became pregnant or lactated or expected to become pregnant during study treatment and 180 days after the last dose of study treatment
• Participants were known to be allergic to the ingredients or excipients of the study drug
• Participants had previously been treated with a known PARP inhibitor or had participated in any treatment group that included the use of a known PARP inhibitor
• Participants received bevacizumab maintenance therapy
• Subjects received investigational therapy within 4 weeks or at intervals not exceeding 5 investigational drug half-lives, whichever is longer, prior to the study's first scheduled dosing date
• Participants had known grade 3 anemia, neutropenia or thrombocytopenia that persisted due to prior chemotherapy. 4 weeks；
• Throughout the study treatment period, participants were treated with conditions (such as transfusion-dependent anemia or thrombocytopenia) or laboratory abnormalities that could confound study results or interfere with their participation, including:
• Participants received blood transfusions (platelets or red blood cells) within 2 weeks of the first dose of study treatment
• Participants received colony stimulating factor (e.g., granulocyte-colony-stimulating factor \[G-CSF\] or recombinant erythropoietin) within 2 weeks prior to the first dose of study treatment;
• Participants had been diagnosed and/or treated for invasive cancer less than 5 years prior to enrollment

Sponsors & Collaborators

• Ruijin Hospital: lead

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

niraparib

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: March 1, 2023
• Study Start: May 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2025
• Last Updated: May 16, 2023

Record last verified: 2023-01