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

Efficacy and Safety of Huaier Granule in Combination With Nilaparil in First-line Maintenance Therapy in Postoperative Patients With Stage III/IV BRCA Wild-type Ovarian Cancer: a Single-center Prospective, Single-arm Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ovarian Cancer
• Intervention / Treatment: Drug: Huaier granule

Detailed Description

Primary objective :

1) To evaluate the efficacy of Huaier granule combined with immunotargeted drugs in the treatment of postoperative ovarian cancer patients

Secondary objectives:

1)To analyze the safety of Huaier granule in the treatment of postoperative ovarian cancer patients; 2)2) To analyze the influence of Huaier granule on postoperative quality of life of patients with ovarian cancer.

• Study Type: Interventional
• Enrollment (Anticipated): 59
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Huaier granule; 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; Oral administration, 20 g once, 3 times a day, continued until progression or intolerance of toxicity; Other Names: Niraparib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Progression Free survival	mPFS is defined as the median time from study entry to date of first documented objective tumor recurrence according to RECIST 1.1	Every 3 month until 2 years from start of treatment
1-year progression-free survival rate	The time from study entry to the time of disease progression as determined by the investigator (by clinical, radiological or pathological means) or death from any cause	up to 1 years
Median overall survival	Median observed length of life from entry into the study to death; or for living patients, the date of last contact regardless of whether or not this contact is on a subsequent protocol	Every 3 month until 2 years from start of treatment
1 year overall survival rate	Observed length of life from entry into the study to death; or for living patients, the date of last contact regardless of whether or not this contact is on a subsequent protocol.	1 year
overall survival	OS is defined as the time from start of treatment to date of death due to any cause, or last patient contact	From study entry to death or last contact, up to 2 years of follow-up
Quality of life score（ EQ-5D）	questionnaires to be completed by patients and collected frequently during the trial	Every 3 month until 2 years from start of treatment
Quality of life score（EORTC-QLQ-OV28）	Assessment of quality of life according to the QLQ-OV28/EORTC scales	Every 3 month until 2 years from start of treatment
Quality of life score（EORTC-QLQ-C30）	Assessment of quality of life according to the QLQ-C30/EORTC scales	Every 3 month until 2 years from start of treatment
Quality of life score（FACT-O）	The FACT-O questionnaire consists of a Physical Well-Being Section, Social/Family Well-Being Section, Emotional Well-Being Section, Functional Well-Being Section, and Additional Concerns Section	Every 3 month until 2 years from start of treatment
the rates of AEs and SAEs	frequency of adverse events according to MedDRA terms	up to 2 years

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 1, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Poly(ADP-ribose) Polymerase Inhibitors; Niraparib
• Other Study ID Numbers: 2023(02)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No