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Ovarian CancerPhase 2NCT05652283

Pamiparib Combined With Surufatinib for the Neoadjuvant Treatment of Unresectable Ovarian Cancer

A Phase 2 study testing Pamiparib and Surufatinib in people with Ovarian Cancer, run by Bai-Rong Xia at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this type of clinical trial study is to evaluate the safety and efficacy of Pamiparib combined with Surufatinib as a new neoadjuvant therapy in newly diagnosed patients with advanced ovarian cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Pamiparib and Surufatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteChina
Study dates
6 Nov 2022to Dec 2028
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Before any procedure of the test is started, informed consent must be provided and filed in the research center.
  • Female subjects ≥ 18 years of age.
  • Biopsy obtained by open surgery, laparoscopic surgery or thick needle puncture, pathologically confirmed as high-grade serous or endometrioid ovarian cancer, peritoneal cancer, or fallopian tube cancer (hereinafter referred to as ovarian cancer), FIGO stage III-IV.
  • Detect tissue samples or blood samples through a testing agency designated by the research center to determine the HRR-related gene mutation or HRD mutation status of patients.
  • The blood and tissue samples of patients before, during, and after treatment can be obtained, and the subjects agree to submit the blood and tissue samples to the Center for the expanded research purpose of the trial, such as possible gene-related research or tumor marker related research.
  • At least one lesion can be measured by CT/MRI.
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  • The professional gynecological oncologists appointed by each center should judge the patients who can not achieve R0 tumor reduction or can not tolerate surgery.
  • The criteria for failure to achieve R0 tumor reduction include but are not limited to:Fagotti endoscopic score ≥ 8 points；When the laparoscopic evaluation method is difficult to implement, the upper abdomen CT score can be ≥ 3 points;
  • The judgment criteria of intolerable surgery can consider:Body mass index: BMI ≥ 40.0；Multiple chronic diseases；Malnutrition or hypoproteinemia Moderate to massive ascites；Newly diagnosed venous thromboembolism (except intermuscular venous thrombosis) (survival time greater than 12 weeks).
  • Expected survival time > 12 weeks.
  • The patient's ECOG score is 0-2.
  • Good organ function, including:Bone marrow function: neutrophil count ≥ 1500/µ L; Platelet ≥ 100000/µ L; Hemoglobin ≥ 10g/dL；Liver function: total bilirubin ≤ 1.5 times the upper limit of normal value or direct bilirubin ≤ 1.0 times the upper limit of normal value; AST and ALT ≤ 2.5 times the upper limit of normal value, and when liver metastasis exists, it must be ≤ 5 times the upper limit of normal value Renal function: serum creatinine ≤ 1.5 times the upper limit of normal value, or creatinine clearance rate ≥ 60mL/min (calculated according to Cockcroft Gault formula).
  • For women with fertility potential, the blood test or urine pregnancy test was negative within one week before enrollment. After enrollment, effective contraceptive measures must be taken, such as using physical barrier contraceptive methods (condoms) or complete abstinence; Oral, injectable, or implanted hormonal contraceptives are not allowed.

Who cannot join

  • Personnel involved in the formulation or implementation of the research plan.
  • Use other experimental research drugs and participate in other clinical drug experiments while the study is being conducted.
  • At the same time of the study, use other new adjuvant therapies for tumors, including but not limited to chemotherapy, radiotherapy, immunotherapy, microbial therapy, traditional Chinese medicine, and other experimental therapies.
  • People who are known to be allergic to active or inactive ingredients of Pamiparib, Surufatinib or drugs with similar chemical structures to the two drugs.
  • Unable to swallow the oral drug, and suffering from any gastrointestinal disease that may interfere with the absorption and metabolism of the study drug, such as uncontrollable nausea and vomiting, gastrointestinal obstruction or malabsorption.
  • Have received any anti-cancer treatment related to ovarian cancer.
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  • Have received known or possible PARP inhibitor treatment in the past.
  • Symptomatic or uncontrolled brain metastasis requiring simultaneous treatment, including but not limited to surgery, radiation and/or corticosteroids, or clinical manifestations of spinal cord compression.
  • Major surgery was performed within 3 weeks before the start of the study, or it has not recovered after surgery.
  • Subjects had other malignant diseases in the past 3 years, except for effectively treated skin squamous cell carcinoma, basal-like carcinoma, breast intraductal carcinoma in situ or cervical carcinoma in situ.
  • The patient has myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) previously or currently diagnosed.
  • Suffering from serious and uncontrollable diseases or the investigator judged that the subject was generally not suitable for the study, including but not limited to: active virus infection, such as human immunodeficiency virus, hepatitis B, hepatitis C, etc.; Severe cardiovascular disease, uncontrollable ventricular arrhythmia, and myocardial infarction in the last 3 months; Uncontrolled seizures, unstable spinal cord compression, superior vena cava syndrome or other mental disorders that affect the patient's informed consent; Hypertension beyond drug control; Immune deficiency (excluding splenectomy) or other diseases that the researchers believe may expose the patient to high-risk toxicity.
  • Any medical history or existing clinical evidence indicates that there may be circumstances that may confuse the study results, interfere with patients' compliance with the trial protocol during the whole study treatment period or are not in the best interests of patients.
  • The patient received platelet or red blood cell infusion within 3 days before the start of treatment of the study drug.
  • Patients who are pregnant or nursing, or who are expected to become pregnant during the study treatment.
  • There are unresolved previous treatment toxicity (≥ grade 2, excluding alopecia, neuralgia, lymphocytopenia, and depigmentation of skin) in clinic.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Bai-Rong Xia, MD contact

18604516165

xiabairong9999@126.com

Wenjing Jiang, Doctor contact

13965145956

jiangwenjing928@126.com

China1 site, 1 recruiting

  • Anhui Cancer Hospital

    Hefei, Anhui, 230001

    Bai-Rong Xia, MD, 18604516165, xiabairong9999@126.com

    Recruiting

Other trials in China

About this study

Official title: An Exploratory Clinical Study of Neoadjuvant Therapy With Pamiparib Combined With Surufatinib for Advanced Ovarian Cancer: A Single-arm, Prospective, Single-center Clinical Study

The goal of this type of clinical trial study is to evaluate the safety and efficacy of Pamiparib combined with Surufatinib as a new neoadjuvant therapy in newly diagnosed patients with advanced ovarian cancer.

Read the detailed description

Patients will have tests and exams to see if they are eligible for the clinical trial. If found eligible, the patient will receive Pamiparib twice daily and Surufatinib once daily taken by mouth every 3 weeks.

Patients who had no progression after neoadjuvant therapy were treated with surgery, and 4 cycles of chemotherapy were given after surgery.

Conditions
Ovarian Cancer
Being tested
Pamiparib, Surufatinib
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • PamiparibDrug

    Also called BAIHUIZE

    Pamiparib capsule 40 mg/time, twice a day, oral, 3 weeks as a cycle, 3 cycles

  • SurufatinibDrug

    Also called SULANDA

    Surufatinib 250 mg/time, once a day, oral, 3 weeks as a cycle, 2 cycles

Study groups in NCT05652283
Study groupRoleWhat they receive
experience groupExperimentalPamiparib 40 mg, BID, oral, 3 weeks as a cycle, 3 cycles Surufatinib 250 mg, QD, oral, 3 weeks as a cycle, 2 cycles
Receives: Drug: Pamiparib; Drug: Surufatinib

What is being measured

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

  1. R0 resection rate

    the percentage of patients received R0 resection after Pamiparib combined with Surufatinib neoadjuvant therapy

    Measured: 3-month

Secondary outcomes (4)

  1. Overall Response Rate (ORR) After Neoadjuvant treatment

    Overall Response Rate according to RECIST1.1 after Neoadjuvant treatment. 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

  2. Pathological complete remission rate

    No residual invasive carcinoma was found under the microscope, but ductal carcinoma in situ could be found; In addition, compare the amount of cancer cells in the specimen before and after the new adjuvant therapy, and use of the Miller Payne grading system to evaluate the effect of the new adjuvant therapy

    Measured: 3-month

  3. 12-month disease-free survival rate

    The rate of patients who did not have any event from the beginning of enrollment to 12 months, including disease progression, inoperable, local or remote recurrence, and death from any cause

    Measured: 12 months

  4. 12-month survival rate

    Rate of patients who did not have a death event from enrollment to 12 months

    Measured: 12 months

Timeline

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

  1. First posted15 Dec 2022
  2. Study start6 Nov 2022
  3. Primary completionMar 2027 (estimated)
  4. Study completionDec 2028 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05652283
Sponsor's protocol ID
AnhuiCancer
Status last verified
Sep 2026
First submitted
27 Nov 2022
Last updated
2 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pamiparib and Surufatinib in people with Ovarian Cancer, run by Bai-Rong Xia 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 13 inclusion and 16 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 2 Oct 2026. 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 Bai-Rong Xia, MD (18604516165, xiabairong9999@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

R0 resection rate (time frame: 3-month). 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 NCT05652283.

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 2 Oct 2026.

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