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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorObstetrics & Gynecology Hospital of Fudan University

About this trial

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.

Eligibility criteria

Qualifiers

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);

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Neoadjuvant Therapy Plus Surgery

Treatment groups

49 Participants
are divided into 1 treatment group

Locations

1
Obstetrics and Gynecology Hospital of Fudan University201101, Shanghai China

Sponsors and collaborators

Obstetrics & Gynecology Hospital of Fudan University

Lead sponsor