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Ovarian CancerNCT05749211

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

A study testing Huaier granule in people with Ovarian Cancer, run by Ruijin Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Huaier granule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
No sites listed yet
Study dates
May 2023to Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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

About this study

Official title: 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.

Read the 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.

Conditions
Ovarian Cancer
Being tested
Huaier granule
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Huaier granuleDrug

    Also called Niraparib

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

Study groups in NCT05749211
Study groupRoleWhat they receive
Huaier granuleExperimentalHuaier 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.
Receives: Drug: Huaier granule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free survival (PFS)

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

    Measured: up to 2 years from start of treatment

Secondary outcomes (10)

  1. 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

    Measured: Every 3 month until 2 years from start of treatment

  2. 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

    Measured: up to 1 years

  3. 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

    Measured: Every 3 month until 2 years from start of treatment

  4. 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.

    Measured: 1 year

  5. overall survival

    OS is defined as the time from start of treatment to date of death due to any cause, or last patient contact

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

  6. Quality of life score（ EQ-5D）

    questionnaires to be completed by patients and collected frequently during the trial

    Measured: Every 3 month until 2 years from start of treatment

  7. Quality of life score（EORTC-QLQ-OV28）

    Assessment of quality of life according to the QLQ-OV28/EORTC scales

    Measured: Every 3 month until 2 years from start of treatment

  8. Quality of life score（EORTC-QLQ-C30）

    Assessment of quality of life according to the QLQ-C30/EORTC scales

    Measured: Every 3 month until 2 years from start of treatment

  9. 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

    Measured: Every 3 month until 2 years from start of treatment

  10. the rates of AEs and SAEs

    frequency of adverse events according to MedDRA terms

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2023
  2. Study startMay 2023 (estimated)
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
59 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05749211
Sponsor's protocol ID
2023(02)
Status last verified
Jan 2023
First submitted
19 Jan 2023
Last updated
16 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Huaier granule in people with Ovarian Cancer, run by Ruijin Hospital.

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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free survival (PFS) (time frame: up to 2 years from start of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05749211.

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 16 May 2023.

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