Skip to content

Prospective, single-arm, multicenter phase II clinical study of pamiparib combined with TC regimen and bevacizumab in neoadjuvant therapy for untreated advanced ovarian cancer

Prospective, single-arm, multicenter phase II clinical study of pamiparib combined with TC regimen and bevacizumab in neoadjuvant therapy for untreated advanced ovarian cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059119
Enrollment
Unknown
Registered
2022-04-25
Start date
2023-03-14
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ovarian cancer

Interventions

Experimental group:Paclitaxel: 135-175mg/m2 intravenous injection, d1. Carboplatin: AUC=5 intravenous drip, d2. A cycle of 21 days is considered, not exceeding 6 cycles, mainly determined by the resea
pamiparib: 40mg, bid.

Sponsors

Fujian Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years; 2. Newly diagnosed patients with ovarian cancer, tubal cancer, or peritoneal cancer with FIGO stage ?-? and pathological diagnosis of high-grade serous adenocarcinoma or endometrioid adenocarcinoma; 3. Patients with unsatisfactory tumor reduction; 4. ECOG score is 0-2 points; 5. Measurable lesions consistent with RECIST 1.1; 6. Adequate organ and bone marrow function, as defined below: (1) Neutrophil count (ANC) >= 1,500/mm^3 (1.5 x 10^9/L) (no growth factor was used within 14 days); (2) Platelet count (PLT) >= 100,000/mm^3 (100 x 10^9/L) (no corrective treatment was used within 7 days); (3) Hemoglobin (Hb) >= 9 g/dL (90 g/L) (no corrective therapy was used within 7 days); (4) Serum creatinine = 60 ml/min; (5) Total bilirubin (BIL) <= 1.5 times the upper limit of normal value (ULN); (6) The levels of aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) were less than 2.5 times the upper limit of normal value (ULN), and patients with liver metastasis were less than 5 x ULN; 7. Patients of reproductive age are willing to use a medically approved highly effective contraceptive method within 3 months after signing the informed consent form, during the study period, and after the last study drug administration; 8. With the patient's consent and signed informed consent, the patient is willing and able to follow the planned visit, research treatment plan, laboratory examination and other experimental procedures.

Exclusion criteria

Exclusion criteria: 1. Patients with history of brain metastasis or signs of brain metastasis; 2. Patients with active bleeding or bleeding tendency; 3. Hypertension that cannot be controlled by drugs; 4. Major operation was performed within 4 weeks before enrollment; 5. No intestinal obstruction or BEV contraindications; 6. Had been diagnosed with any other malignancies within the 3 years prior to enrollment, except for non-melanoma skin cancer after radical treatment, basal cell or squamous cell skin cancer, or carcinoma in situ; 7. In the 6 months before the study, the following situations occurred: Myocardial infarction, severe/unstable angina pectoris, NYHA grade 2 or above cardiac insufficiency, persistent arrhythmias >= grade 2 (according to NCI CTCAE version 5.0), atrial fibrillation of any grade, coronary/peripheral arterial bridging, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack), Or symptomatic pulmonary embolism; 8. Inability to swallow, intestinal obstruction, or other factors affecting drug use and absorption; 9. Known allergy to the test drug or any excipients; 10. Known history of allogeneic organ transplantation or allohematopoietic stem cell transplantation; 11. Known history of psychotropic substance abuse or drug use; 12. Pregnant or lactating patients; 13. The presence of other serious physical or mental illnesses or abnormalities in laboratory tests that may increase the risk of study participation or interfere with the study results, as well as patients deemed unsuitable for study participation by the investigator.

Design outcomes

Primary

MeasureTime frame
Pathological chemotherapy response score;

Secondary

MeasureTime frame
Pathological complete response rate;Satisfactory tumor reduction rate;Progression-free survival;safety;

Countries

China

Contacts

Public ContactXu Qin

Fujian Cancer Hospital

1379423879@qq.com+86 139 5041 9396

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026