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

Bai-Rong Xia1 site in 1 country37 target enrollmentNovember 6, 2022

ConditionsOvarian Cancer

InterventionsPamiparib Surufatinib

Overview

Phase: Phase 2
Intervention: Pamiparib
Conditions: Ovarian Cancer
Sponsor: Bai-Rong Xia
Enrollment: 37
Locations: 1
Primary Endpoint: R0 resection rate
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

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.

Registry

clinicaltrials.gov

Start Date

November 6, 2022

End Date

May 1, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Bai-Rong Xia

Responsible Party

Sponsor Investigator

Principal Investigator

Bai-Rong Xia

Chairman of Department of Gynaecology Surgery

Anhui Provincial Cancer Hospital

Eligibility Criteria

Inclusion Criteria

•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.
•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.

Exclusion Criteria

•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.
•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.