Newly diagnosed and histopathologically confirmed epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer
Conditions
Interventions
Trial group:Sennaparib 100 mg per dose, taken orally on an empty stomach, once daily (QD), until disease progression or intolerable adverse reactions terminate treatment.
Sponsors
Sun Yat-sen University Cancer Center (Sun Yat-sen University Cancer Hospital, Sun Yat-sen University Cancer Research Institute)
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Female, age >= 18 years; 2. Patients with newly diagnosed, histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; 3. FIGO Stage III–IV HRP advanced patients (HRD status must be determined by OncoScreen® Plus HRD [520 BridgeScore]); 4. Stage III subjects must have undergone one optimal debulking surgery (primary or interval cytoreduction); Stage IV subjects must have undergone biopsy and/or primary or interval cytoreduction; 5. Patients who achieved CR/PR after first-line platinum-based chemotherapy ± bevacizumab, with first-line platinum chemotherapy consisting of a minimum of 6 and maximum of 9 cycles; subjects who discontinued platinum chemotherapy prematurely due to toxicity must have received at least 4 cycles of platinum-based therapy; 6. ECOG performance status 0–1; 7. CA125 requirements prior to treatment: if the first measurement is ULN, a second assessment must be performed at least 7 days later; if the second value is >= 15% higher than the first, enrollment is excluded; 8. Adequate major organ function with laboratory parameters meeting the following criteria (correction and supportive therapy permitted within 1 week prior to enrollment): hematology (HB >= 100 g/L, ANC >= 1.5×10^9/L, PLT >= 1×10^11/L); biochemistry (ALT/AST <= 2.5×ULN, TBIL <= 1.5×ULN, Cr <= 1.5×ULN); coagulation (APTT, INR, PT <= 1.5×ULN); 9. Female subjects must have negative urine or serum hCG (except for postmenopausal or hysterectomized women); women of childbearing potential and their partners must use effective contraception during the trial and for 6 months after the last dose; 10. Enrollment screening must be completed and trial drug initiation must occur within 8–12 weeks after the last dose of chemotherapy; 11. Patient has signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. History of other malignancies within the past 5 years, except for cured thyroid cancer, non-melanoma skin cancer, effectively treated cervical carcinoma in situ, Stage I ductal carcinoma in situ (DCIS), Stage I Grade 1 endometrial cancer, or other solid tumors including lymphoma with effective treatment and no evidence of disease progression for more than five years; 2. Prior treatment with a PARP inhibitor; 3. Untreated active central nervous system metastases; 4. Diseases affecting the absorption, distribution, metabolism, or elimination of the study drug (e.g., severe vomiting, chronic diarrhea, bowel obstruction, malabsorption); 5. Presence of ascites or pleural effusion requiring paracentesis or drainage, or receipt of peritoneal or pleural drainage within 2 months prior to first dose of sennaparib; 6. Clinically significant cardiac disease, including but not limited to: NYHA Class III or higher congestive heart failure; history of myocardial infarction or unstable angina within 6 months prior to treatment; stroke or transient ischemic attack within 6 months prior to treatment; 7. Active infection, including: human immunodeficiency virus (HIV) (HIV1/2 antibody positive); active hepatitis C virus (HCV antibody positive or HCV-RNA >= 10^3 copies/mL with abnormal liver function); active co-infection with hepatitis B virus (HBV) and hepatitis C virus (HCV).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year progression-free survival rate (1y-PFS%); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival(PFS);2-year progression-free survival rate (2y-PFS%); | — |
Countries
China
Contacts
Public ContactLi Jundong
Sun Yat-sen University Cancer Center (Sun Yat-sen University Cancer Hospital, Sun Yat-sen University Cancer Research Institute)
Outcome results
None listed