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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Neoadjuvant Therapy Plus Surgery

    Procedure/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.

Treatment groups

49 Participants
are divided into 1 treatment group
Group A: Experimental ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

median progression-free survival (PFS)

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.

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: