Ovarian CancerPhase 2NCT06437353
Surufatinib Combined With Carboplatin/Paclitaxel and Surufatinib Combined With Olaparib as First-line and Maintenance Therapy for Newly Diagnosed High-risk Ovarian Cancer
A Phase 2 study testing Paclitaxel in people with Ovarian Cancer, run by Anhui Provincial Cancer Hospital at 1 site in China.
Trial summary
The goal of this type of clinical trial study is to evaluate the safety and efficacy of Surufatinib combined with Carboplatin/Paclitaxel and Surufatinib combined with Olaparib as first-line and maintenance therapy for newly diagnosed high-risk ovarian cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2024to 30 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-75 years old (≥18, ≤75)
- Patients with newly diagnosed FIGO stage III or IV high-grade serous ovarian cancer, high-grade endometrioid carcinoma, primary peritoneal cancer, and/or fallopian tube cancer with high-risk factors for recurrence. High-risk recurrence is defined as follows:
- FIGO stage III with non-R0 resection;
- FIGO stage IV;
- Presence of ascites at initial diagnosis.
- Patients who have undergone primary debulking surgery (PDS) for ovarian cancer.
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- ECOG performance status score: 0-2.
- Postoperative administration time ≤12 weeks.
- Expected survival of at least 3 months.
- Major organ function within 7 days prior to treatment meets the following criteria:
- Hemoglobin (HB) ≥90 g/L;
- Absolute neutrophil count (ANC) ≥1.5×10⁹/L;
- Platelets (PLT) ≥100×10⁹/L.
- Biochemical parameters must meet the following standards:
- Total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN);
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, or ≤5×ULN if liver metastases are present;
- Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr) ≥60 ml/min.
- Women of childbearing potential must use effective contraception.
- Subjects must voluntarily join the study and sign the informed consent form (ICF).
- Subjects are expected to have good compliance and the ability to follow up on efficacy and adverse reactions as required by the protocol.
Who cannot join
- Previous treatment with anti-angiogenic drugs such as apatinib, sorafenib, anlotinib, bevacizumab, or other anti-angiogenic therapies.
- Pregnant or breastfeeding women.
- Patients who have previously participated in other clinical trials that have not yet concluded.
- Patients with evidence or history of significant bleeding tendencies or events within 3 months before enrollment (bleeding >30 mL, accompanied by hematemesis, melena, or hematochezia), hemoptysis (≥5 mL of fresh blood within 4 weeks), or thromboembolic events (including stroke and/or transient ischemic attack) within 12 months.
- Patients with uncontrolled hypertension (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg).
- Patients with grade I or higher myocardial ischemia or infarction, arrhythmias (including QTc ≥480 ms), or ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification).
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- Patients with active or uncontrolled severe infections (≥CTC AE grade 2).
- Patients with renal failure requiring hemodialysis or peritoneal dialysis.
- Patients with a history of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases, or those with a history of organ transplantation.
- Patients with persistent proteinuria (≥++) on two consecutive urine tests, and confirmed 24-hour urine protein >1.0 g.
- Patients with psychiatric disorders, including epilepsy, dementia, severe depression, mania, etc.
- Patients with any signs or history of bleeding disorders, regardless of severity; patients who experienced any bleeding or hemorrhagic event ≥CTCAE grade 3 within 4 weeks before enrollment; patients with unhealed wounds, ulcers, or fractures.
- Patients who had arterial or venous thrombotic events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism, within the past 6 months.
- Patients with symptomatic brain metastases or those whose symptoms have been controlled for less than 2 months.
- Patients with a history of substance abuse that cannot be relinquished or those with psychiatric disorders.
- Patients with difficulty swallowing or known absorption disorders affecting drug intake.
- Patients allergic to treatment drugs sorafenib or paclitaxel/carboplatin.
- Any other condition that the researcher deems unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Anhui Cancer Hospital
Hefei, Anhui, 230001
Bairong Xia, MD, 18604516165, xiabairong9999@126.com
Wenjing Jiang, 13965145956, jiangwenjing928@126.com
About this study
Official title: Sorafenib Combined With Carboplatin/Paclitaxel and Sorafenib Combined With Olaparib as First-line and Maintenance Therapy for Newly Diagnosed High-risk Ovarian Cancer: a Single-arm, Multicenter, Exploratory Clinical Study
The goal of this type of clinical trial study is to evaluate the safety and efficacy of Surufatinib combined with Carboplatin/Paclitaxel and Surufatinib combined with Olaparib as first-line and maintenance therapy for newly diagnosed high-risk ovarian cancer
Read the detailed description
Patients will have tests and exams to see if they are eligible for the clinical trial.
First-line chemotherapy regimen:
Paclitaxel/Carboplatin(repeat every 3 weeks, total of 6 cycles):
- Paclitaxel: 175 mg/m², intravenous infusion, on day 1.
- Carboplatin: AUC 5, intravenous infusion, on day 1.
- For patients aged ≥70 years or those with comorbidities, the paclitaxel dose can be adjusted to 135 mg/m².
Surufatinib(repeat every 3 weeks, total of 5 cycles):
- Surufatinib is not used during the first postoperative cycle.
- Starting from the second postoperative cycle, surufatinib is administered at a dose of 250 mg once daily, taken continuously.
Maintenance Therapy Regimen:
HRD-positive Patients:
- Surufatinib: 250 mg once daily, taken continuously.
- Olaparib: 300 mg twice daily, with doses taken 12 hours apart. Olaparib can be used for a maximum of 2 years.
HRD-negative or HRD Status Unknown Patients:
- Surufatinib: 250 mg once daily, taken continuously.
Treatment continues until the patient experiences disease progression or meets other criteria for discontinuation of the study treatment as specified in the protocol.
- Conditions
- Ovarian Cancer
- Being tested
- Paclitaxel
- Keywords
- Antiangiogenic
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called Surufatinib, Carboplatin
First-line chemotherapy regimen:
- Paclitaxel: 175 mg/m², intravenous infusion, on day 1.
- Carboplatin: AUC 5, intravenous infusion, on day 1.
- Surufatinib：250 mg once daily, taken continuously.
Maintenance Therapy Regimen:
- Surufatinib: 250 mg once daily, taken continuously.
- Olaparib: 300 mg twice daily.
| Study group | Role | What they receive |
|---|---|---|
| First-line and maintenance therapy regimen | Experimental | First-line chemotherapy regimen:
* Paclitaxel: 175 mg/m², intravenous infusion, on day 1.
* Carboplatin: AUC 5, intravenous infusion, on day 1.
* Surufatinib：250 mg once daily, taken continuously.
Maintenance Therapy Regimen:
* Surufatinib: 250 mg once daily, taken continuously.
* Olaparib: 300 mg twice daily. Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Progression-free survival on first-line and maintenance therapy with Surufatinib Combined With Carboplatin/Paclitaxel and Surufatinib Combined With Olaparib
Measured: 12-month
Secondary outcomes (4)
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
Measured: 3-month
Disease control rate
the percentage of patients with complete response, partial response, and stable disease for more than 4 weeks in which response can be evaluated
Measured: 3-month
Overall survival
the date of enrollment to the date of death from any cause
Measured: 3-years
Adverse event
Adverse medical events in clinical trial subjects treated with Surufatinib Combined With Carboplatin/Paclitaxel and Surufatinib Combined With Olaparib
Measured: 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start25 May 2024
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hutchison Medipharma Limited
- Responsible party
- Principal investigator, Bai-Rong Xia, Anhui Provincial Cancer Hospital
- Investigators
- Bairong Xia, Doctor, Study chair, Anhui Provincial Cancer HospitalWenjing Jiang, Study director, Anhui Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437353
- Sponsor's protocol ID
- 2024 No. 047
- Status last verified
- Nov 2024
- First submitted
- 26 May 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sorafenib Combined With Carboplatin/Paclitaxel and Sorafenib Combined With Olaparib as First-line and Maintenance Therapy for Newly Diagnosed High-risk Ovarian Cancer: a Single-arm, Multicenter, Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT06437353
- Acronym / sponsor ID
- 2024 No. 047
- Conditions
- Ovarian Cancer
- Keywords
- Antiangiogenic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Anhui Provincial Cancer HospitalUniversity, hospital or other
- Collaborators
- Hutchison Medipharma Limited
- Study start
- 25 May 2024 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 31 May 2024 (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.
The goal of this type of clinical trial study is to evaluate the safety and efficacy of Surufatinib combined with Carboplatin/Paclitaxel and Surufatinib combined with Olaparib as first-line and maintenance therapy for newly diagnosed high-risk ovarian cancer
Detailed description
Patients will have tests and exams to see if they are eligible for the clinical trial.
First-line chemotherapy regimen:
Paclitaxel/Carboplatin(repeat every 3 weeks, total of 6 cycles):
- Paclitaxel: 175 mg/m², intravenous infusion, on day 1.
- Carboplatin: AUC 5, intravenous infusion, on day 1.
- For patients aged ≥70 years or those with comorbidities, the paclitaxel dose can be adjusted to 135 mg/m².
Surufatinib(repeat every 3 weeks, total of 5 cycles):
- Surufatinib is not used during the first postoperative cycle.
- Starting from the second postoperative cycle, surufatinib is administered at a dose of 250 mg once daily, taken continuously.
Maintenance Therapy Regimen:
HRD-positive Patients:
- Surufatinib: 250 mg once daily, taken continuously.
- Olaparib: 300 mg twice daily, with doses taken 12 hours apart. Olaparib can be used for a maximum of 2 years.
HRD-negative or HRD Status Unknown Patients:
- Surufatinib: 250 mg once daily, taken continuously.
Treatment continues until the patient experiences disease progression or meets other criteria for discontinuation of the study treatment as specified in the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First-line and maintenance therapy regimen | Experimental | Drug: PaclitaxelFirst-line chemotherapy regimen: * Paclitaxel: 175 mg/m², intravenous infusion, on day 1. * Carboplatin: AUC 5, intravenous infusion, on day 1. * Surufatinib：250 mg once daily, taken continuously. Maintenance Therapy Regimen: * Surufatinib: 250 mg once daily, taken continuously. * Olaparib: 300 mg twice daily. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Age: 18-75 years old (≥18, ≤75)
- Patients with newly diagnosed FIGO stage III or IV high-grade serous ovarian cancer, high-grade endometrioid carcinoma, primary peritoneal cancer, and/or fallopian tube cancer with high-risk factors for recurrence. High-risk recurrence is defined as follows:
- Patients who have undergone primary debulking surgery (PDS) for ovarian cancer.
- ECOG performance status score: 0-2.
- Postoperative administration time ≤12 weeks.
Key exclusion criteria (18 listed)
- Previous treatment with anti-angiogenic drugs such as apatinib, sorafenib, anlotinib, bevacizumab, or other anti-angiogenic therapies.
- Pregnant or breastfeeding women.
- Patients who have previously participated in other clinical trials that have not yet concluded.
- Patients with evidence or history of significant bleeding tendencies or events within 3 months before enrollment (bleeding >30 mL, accompanied by hematemesis, melena, or hematochezia), hemoptysis (≥5 mL of fresh blood within 4 weeks), or thromboembolic events (including stroke and/or transient ischemic attack) within 12 months.
- Patients with uncontrolled hypertension (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg).
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 |
|---|---|---|
| PaclitaxelAlso: Surufatinib, CarboplatinFirst-line chemotherapy regimen: * Paclitaxel: 175 mg/m², intravenous infusion, on day 1. * Carboplatin: AUC 5, intravenous infusion, on day 1. * Surufatinib：250 mg once daily, taken continuously. Maintenance Therapy Regimen: * Surufatinib: 250 mg once daily, taken continuously. * Olaparib: 300 mg twice daily. | Drug | First-line and maintenance therapy regimen |
Primary outcome
Progression free survival
Time frame: 12-month
Progression-free survival on first-line and maintenance therapy with Surufatinib Combined With Carboplatin/Paclitaxel and Surufatinib Combined With Olaparib
4 secondary outcomes
Overall Response Rate (ORR
Time frame: 3-month
Disease control rate
Time frame: 3-month
Overall survival
Time frame: 3-years
Adverse event
Time frame: 3-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Bairong Xia, Doctor study chair
Anhui Provincial Cancer Hospital
Wenjing Jiang study director
Anhui Provincial Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel in people with Ovarian Cancer, run by Anhui Provincial Cancer Hospital at 1 site in China.
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 20 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bairong Xia, Doctor (18604516165, xiabairong9999@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 12-month). 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 27 Nov 2024.