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Not yet recruiting NCT07673835

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

Phase II Interventional Ovarian Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neoadjuvant Therapy Plus Surgery.
Who it may be relevant to
Registry conditions: Ovarian Cancer. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Procedure 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.

Primary outcome measures

  • median progression-free survival (PFS) [Time frame: 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.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Obstetrics and Gynecology Hospital of Fudan University — Shanghai

Identifiers

NCT: NCT07673835 · FUOBGY-2026-56

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗