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Not yet recruitingNCT07673835Updated Jun 29, 2026

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

A Phase 2 interventional study of Neoadjuvant Therapy Plus Surgery in Ovarian Cancer, sponsored by Obstetrics & Gynecology Hospital of Fudan University. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by Obstetrics & Gynecology Hospital of Fudan University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
49
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Ovarian Cancer

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Keywords

  • Ovarian Cancer
  • Neoadjuvant Therapy
  • Chemotherapy
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts 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

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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
49 participants (estimated)

Study arms

  • Experimental
    Experimental Arm

    Participants will receive immunotherapy combined with platinum-based chemotherapy administered every 3 weeks for 3-4 cycles, followed by interval cytoreductive surgery. Adjuvant chemotherapy will be given postoperatively according to pathological results.

    Procedure: Neoadjuvant Therapy Plus Surgery

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.

05

What researchers measure

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.

06

Study locations

1 site
  • Obstetrics and Gynecology Hospital of Fudan University
    Shanghai, 201101, China
07

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07673835
Lead sponsor
Obstetrics & Gynecology Hospital of Fudan University
Responsible party
Sponsor
First posted
Jun 29, 2026
Start date
Jun 6, 2026 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Jun 29, 2026

Study contacts

Xin Wu, Dr
Contact
wuxin_fc@fudan.edu.cn
86 21 33189900

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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