Primary Ovarian CancerNCT05792254
Huaier Granule in Patients With Stage I Primary Ovarian Fallopian Tube Cancer After Peritoneal Cancer
A study testing Huaier granule in people with Primary Ovarian Cancer and Fallopian Tube Cancer, run by Ruijin Hospital.
Trial summary
This study is an exploratory, single-center, prospective single-arm study to explore the efficacy of Huaier granules in the treatment of stage Ⅱ-Ⅳ primary ovarian cancer, fallopian tube cancer, and peritoneal cancer after satisfactory tumor reduction (R0/R1). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Primary Ovarian Cancer, Fallopian Tube Cancer, Peritoneal 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
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 2023to May 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18years old
- Histopathologically confirmed FIGO II-IV stage primary ovarian cancer peritoneal or fallopian tube cancer
- Patients who underwent primary tumor reduction or intermediate tumor reduction with satisfactory results (R0/R1) within 15 days after surgery
- After tumor reduction, the physician assessed that chemotherapy was not suitable or the patient was unwilling to receive chemotherapy
- Life expectancy is 3 months
- Liver and kidney function :
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- AST and ALT 3 times the upper limit of normal value or 5 times the upper limit of normal value in the presence of liver metastasis; T
- he upper limit of total bilirubin 3 times normal value;
- Serum creatinine is 3 times the upper limit of normal
- No other tumors, no history of other malignant tumors (except non-melanoma skin cancer in situ cervical cancer or other cancers that have received curative treatment and have no signs of disease for at least 5 years)
- Voluntarily participate in the study and sign the informed consent
Who cannot join
- Breastfeeding women during pregnancy
- Recurrent ovarian cancer
- Known allergy to the study drug;
- Central nervous system diseases or brain metastases;
- History of abdominal/pelvic radiotherapy;
- History of organ transplantation history of immune deficiency disease requiring systemic steroid therapy or other immunosuppressive therapy
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- Hiv-ag /AB test result is positive;
- Complicated with serious cardiovascular and cerebrovascular diseases or other serious diseases affecting follow-up treatment of subjects: such as myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months; Uncontrolled hypertension after antihypertensive therapy (systolic ≥140 or diastolic ≥90 mmHg); Uncontrolled diabetes mellitus (HbA1c>8.0%) etc
- Participate in other clinical study patients within 1 month
- Poor compliance is estimated to be difficult to complete the follow-up
- In addition to the above, the investigator determined that the patients were not suitable for the clinical trial
About this study
Official title: Efficacy and Safety of Huaier Granule in Patients With Stage I Primary Ovarian Fallopian Tube Cancer After Peritoneal Cancer: a Single-center Prospective Single-arm Study
This study is an exploratory, single-center, prospective single-arm study to explore the efficacy of Huaier granules in the treatment of stage Ⅱ-Ⅳ primary ovarian cancer, fallopian tube cancer, and peritoneal cancer after satisfactory tumor reduction (R0/R1). Twenty-five patients with FIGOⅡ-Ⅳ ovarian cancer, peritoneal cancer or tubal cancer confirmed by histopathology were enrolled and treated with Huaier granules. During the study period, the patients were followed up once at 3 months, and the medication was continued until progression or intolerability of toxicity. This is an exploratory, single-center, prospective single-arm study to explore the efficacy of Huaier granules in the treatment of stage Ⅱ-Ⅳ primary ovarian cancer, fallopian tube cancer, and peritoneal cancer after satisfactory tumor reduction (R0/R1). Twenty-five patients with FIGOⅡ-Ⅳ ovarian cancer, peritoneal cancer or tubal cancer confirmed by histopathology were enrolled and treated with Huaier granules. During the study period, the patients were followed up once at 3 months, and the medication was continued until progression or intolerability of toxicity.
Read the detailed description
Primary Objective:
To evaluate the efficacy of Huai er granule in the treatment of stage I primary ovarian cancer, fallopian tube cancer and peritoneal cancer
Secondary objectives:
- To analyze the safety of Huaier granule in the treatment of ovarian fallopian tube cancer and peritoneal cancer after operation;
- To analyze the influence of Huaier granule on the quality of life of postoperative patients with ovarian fallopian tube cancer and peritoneal cancer
Exploratory objective:
To evaluate the efficacy of Huaier granule in patients with BRCA mutation and BRCA wild-type ovarian cancer
- Being tested
- Huaier granule
- Medical subject headings
- Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huaier granuleDrug
Oral Huai Er granules, 20 g once, 3 times a day, continued to progress or intolerance toxicity.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Huaier granule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 from start of treatment
Secondary outcomes (5)
Progression Free survival
PFS according to the RECIST 1.1 criteria, based on the investigator's assessment.
Measured: 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.
Measured: one year
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
pain score
In the Visual Analog Score to be used as the pain measurement criterion, '0' indicates no pain, while '10' defines the most severe pain.
Measured: Every 3 month until 2 years from start of treatment
the Rates of AE and SAE
frequency of adverse events according to MedDRA terms
Measured: Every 3 month until 2 years from start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study startMay 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792254
- Sponsor's protocol ID
- 2023(01)
- Status last verified
- Jan 2023
- First submitted
- 19 Jan 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Huaier Granule in Patients With Stage I Primary Ovarian Fallopian Tube Cancer After Peritoneal Cancer: a Single-center Prospective Single-arm Study
- ClinicalTrials.gov ID
- NCT05792254
- Acronym / sponsor ID
- 2023(01)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 31 Mar 2023 (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.
This study is an exploratory, single-center, prospective single-arm study to explore the efficacy of Huaier granules in the treatment of stage Ⅱ-Ⅳ primary ovarian cancer, fallopian tube cancer, and peritoneal cancer after satisfactory tumor reduction (R0/R1). Twenty-five patients with FIGOⅡ-Ⅳ ovarian cancer, peritoneal cancer or tubal cancer confirmed by histopathology were enrolled and treated with Huaier granules. During the study period, the patients were followed up once at 3 months, and the medication was continued until progression or intolerability of toxicity. This is an exploratory, single-center, prospective single-arm study to explore the efficacy of Huaier granules in the treatment of stage Ⅱ-Ⅳ primary ovarian cancer, fallopian tube cancer, and peritoneal cancer after satisfactory tumor reduction (R0/R1). Twenty-five patients with FIGOⅡ-Ⅳ ovarian cancer, peritoneal cancer or tubal cancer confirmed by histopathology were enrolled and treated with Huaier granules. During the study period, the patients were followed up once at 3 months, and the medication was continued until progression or intolerability of toxicity.
Detailed description
Primary Objective:
To evaluate the efficacy of Huai er granule in the treatment of stage I primary ovarian cancer, fallopian tube cancer and peritoneal cancer
Secondary objectives:
- To analyze the safety of Huaier granule in the treatment of ovarian fallopian tube cancer and peritoneal cancer after operation;
- To analyze the influence of Huaier granule on the quality of life of postoperative patients with ovarian fallopian tube cancer and peritoneal cancer
Exploratory objective:
To evaluate the efficacy of Huaier granule in patients with BRCA mutation and BRCA wild-type ovarian cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Huaier granule | Experimental | Drug: Huaier granuleHuaier 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ≥18years old
- Histopathologically confirmed FIGO II-IV stage primary ovarian cancer peritoneal or fallopian tube cancer
- Patients who underwent primary tumor reduction or intermediate tumor reduction with satisfactory results (R0/R1) within 15 days after surgery
- After tumor reduction, the physician assessed that chemotherapy was not suitable or the patient was unwilling to receive chemotherapy
- Life expectancy is 3 months
Key exclusion criteria (11 listed)
- Breastfeeding women during pregnancy
- Recurrent ovarian cancer
- Known allergy to the study drug;
- Central nervous system diseases or brain metastases;
- History of abdominal/pelvic radiotherapy;
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 |
|---|---|---|
| Huaier granuleOral Huai Er granules, 20 g once, 3 times a day, continued to progress or intolerance toxicity. | Drug | Huaier granule |
Primary outcome
1-year progression-free survival rate
Time frame: up to 1 years from start of treatment
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
5 secondary outcomes
Progression Free survival
Time frame: Every 3 month until 2 years from start of treatment
1 year overall survival rate
Time frame: one year
Quality of life score（FACT-O）
Time frame: Every 3 month until 2 years from start of treatment
pain score
Time frame: Every 3 month until 2 years from start of treatment
the Rates of AE and SAE
Time frame: Every 3 month until 2 years from start of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Huaier granule in people with Primary Ovarian Cancer and Fallopian Tube 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 11 inclusion and 11 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 31 Mar 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?
1-year progression-free survival rate (time frame: up to 1 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?
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 31 Mar 2023.