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

ConditionOvarian Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBai-Rong Xia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Pamiparib

    Drug

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

  • Surufatinib

    Drug

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

Treatment groups

37 Participants
are divided into 1 treatment group
Group A: experience groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

R0 resection rate

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

Time frame
3-month

Secondary outcomes

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.

Time frame
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

Time frame
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

Time frame
12 months
4

12-month survival rate

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

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bai-Rong Xia

Lead sponsor

Anhui Provincial Cancer Hospital

Sponsor institution

Source ClinicalTrials.gov
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