Iparomlimab and Tuvonralimab Plus Chemotherapy as Neoadjuvant Therapy for Ovarian Cancer（Phase II）

Официальное название

Efficacy of Iparomlimab and Tuvonralimab Plus Chemotherapy as Neoadjuvant Therapy for Ovarian Cancer: A Single-Arm, Single-Center Phase II Trial

Обзор

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.

Вмешательства

• Процедура Neoadjuvant 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.

Первичные конечные точки

• median progression-free survival (PFS) [Срок оценки: 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.]

Критерии участия

Критерии включения

• Histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma, FIGO 2014 stage III-IV disease;
• Female patients aged 18 to 75 years;
• Willing and able to provide written informed consent and comply with study visits and protocol-specified procedures;
• Candidates for cytoreductive surgery (debulking surgery);
• At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• Estimated life expectancy of at least 6 months;
• 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;
• Adequate organ function.

Критерии исключения

• Histological subtypes other than epithelial ovarian carcinoma, including mucinous carcinoma and clear cell carcinoma.
• Pregnant women or patients whose most recent pregnancy was terminated within 2 weeks prior to screening.
• Clinically significant hydronephrosis not amenable to stenting or nephrostomy, or presence of CNS metastases or carcinomatous meningitis.
• 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).
• Prior treatment with immune checkpoint inhibitors or other immunomodulatory anticancer therapies.
• Major surgery within 4 weeks before study treatment, or planned major surgery during the study period.
• Severe cardiovascular or cerebrovascular disease.
• Unresolved ≥ Grade 2 toxicity (CTCAE v5.0) from prior anticancer therapy, excluding alopecia.
• Known hypersensitivity to study drugs or their components.
• Any condition that may compromise patient safety or interfere with study evaluation, as judged by the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Obstetrics and Gynecology Hospital of Fudan University — Шанхай

Идентификаторы

NCT: NCT07673835 · FUOBGY-2026-56

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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