Ovarian Cancer
Conditions
Keywords
Ovarian Cancer, Neoadjuvant Therapy, Chemotherapy
Brief summary
This study is a single-arm, single-center prospective clinical study that will evaluate the clinical feasibility and efficacy of immunotherapy combined with chemotherapy in the neoadjuvant treatment of ovarian cancer, in order to explore the progression-free survival of the study population.
Interventions
PROCEDURENeoadjuvant Therapy Plus Surgery
Participants will receive immunotherapy (iparomlimab plus tuvonralimab) combined with platinum-based chemotherapy administered every 3 weeks for 3-4 cycles, followed by cytoreductive surgery. Adjuvant chemotherapy will be given postoperatively based on pathological results.
Sponsors
Obstetrics & Gynecology Hospital of Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma, FIGO 2014 stage III-IV disease; 2. Female patients aged 18 to 75 years; 3. Willing and able to provide written informed consent and comply with study visits and protocol-specified procedures; 4. Candidates for cytoreductive surgery (debulking surgery); 5. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 7. Estimated life expectancy of at least 6 months; 8. Women of childbearing potential must agree to use effective contraception during the study period, and a negative serum or urine pregnancy test is required prior to enrollment; 9. Adequate organ function.
Exclusion criteria
1. Histological subtypes other than epithelial ovarian carcinoma, including mucinous carcinoma and clear cell carcinoma. 2. Pregnant women or patients whose most recent pregnancy was terminated within 2 weeks prior to screening. 3. Clinically significant hydronephrosis not amenable to stenting or nephrostomy, or presence of CNS metastases or carcinomatous meningitis. 4. History of other malignancies within 3 years, except for adequately treated curable cancers (e.g., skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, or carcinoma in situ of the breast). 5. Prior treatment with immune checkpoint inhibitors or other immunomodulatory anticancer therapies. 6. Major surgery within 4 weeks before study treatment, or planned major surgery during the study period. 7. Severe cardiovascular or cerebrovascular disease. 8. Unresolved ≥ Grade 2 toxicity (CTCAE v5.0) from prior anticancer therapy, excluding alopecia. 9. Known hypersensitivity to study drugs or their components. 10. Any condition that may compromise patient safety or interfere with study evaluation, as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| median progression-free survival (PFS) | From first dose of study treatment to disease progression or death from any cause, with patients followed until disease progression, death, or last disease, assessment assessed up to 60 months. | Progression-free survival (PFS) is defined as the time from randomization to the first documented disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first. Median PFS will be estimated using the Kaplan-Meier method. |
Countries
China
Contacts
CONTACTXin Wu, Dr
Outcome results
None listed