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Ovarian CancersPhase 2NCT07663513

Iparomlimab and Tovorilimab (QL1706) Combined With Bevacizumab and Chemotherapy as Neoadjuvant Therapy for Advanced Ovarian Cancer

A Phase 2 study testing Iparomlimab and Tuvonralimab Injection + Bevacizumab + Paclitaxel + Carboplatin in people with Ovarian Cancers, run by Fudan University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a single-center, single-arm clinical study to evaluate the efficacy and safety of iparomlimab and tovorilimab (QL1706) combined with paclitaxel, carboplatin, and bevacizumab as neoadjuvant therapy for advanced ovarian cancer. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Ovarian Cancers
What is being tested?
Iparomlimab and Tuvonralimab Injection + Bevacizumab + Paclitaxel + Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
Jul 2026to Apr 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female, aged 18-75 years.
  • Histologically confirmed high-grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal adenocarcinoma.
  • FIGO stage III-IV unresectable ovarian cancer.
  • Life expectancy ≥16 weeks.
  • No prior anti-tumor therapy, including radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
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  • Adequate organ function, with laboratory test results meeting the following requirements:Hemoglobin (Hb) ≥90 g/L; Absolute neutrophil count (ANC) ≥1.5×10⁹/L; Platelet count (PLT) ≥100×10⁹/L; Total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (or ≤5×ULN in patients with liver metastases); Serum creatinine clearance (CrCl) >50 mL/min (calculated using the Cockcroft-Gault formula); Coagulation function: international normalized ratio (INR) ≤1.5×ULN and activated partial thromboplastin time (APTT) ≤1.5×ULN.
  • The subject agrees to use effective contraceptive measures from the signing of the informed consent form until 120 days after the last dose of the study drug. Female subjects of childbearing potential (15-49 years) must have a negative urine pregnancy test within 7 days before the start of treatment and must not be lactating. A female patient is considered to be of childbearing potential if she has menstruated, has not reached a postmenopausal state (defined as ≥12 consecutive months of amenorrhea for reasons other than menopause), and has not undergone sterilization surgery (e.g., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).
  • No contraindications for surgery.
  • The subject voluntarily participates in this study, signs the informed consent form, is compliant with the protocol, and cooperates with follow-up.

Who cannot join

  • Non-epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (e.g., germ cell tumors), as well as ovarian tumors of low malignant potential (e.g., borderline ovarian tumors).
  • Prior immunotherapy, including immune checkpoint inhibitory antibodies (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies, etc.), immune checkpoint agonistic antibodies (e.g., anti-ICOS, anti-CD40, anti-CD137, anti-GITR, anti-OX40 antibodies, etc.), and immune cell therapy.
  • Known hypersensitivity to large molecule protein preparations. Contraindications or allergy to any component of iparomlimab and tovorilimab (QL1706), paclitaxel, or carboplatin.
  • Major surgery (excluding diagnostic laparoscopy; local surgical treatment of isolated lesions is acceptable) within 28 days before the first dose.
  • History of allogeneic tissue/solid organ transplantation.
  • Presence of a condition requiring systemic corticosteroids (>10 mg prednisone equivalent per day) or other immunosuppressive agents (e.g., cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-α inhibitors, etc.) within 2 weeks before the first dose. Topical corticosteroids, nasal sprays, and inhaled steroids are permitted. Systemic corticosteroids for the prevention of contrast media allergy are allowed.
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  • Active or potentially recurrent autoimmune disease, with the following exceptions: vitiligo, alopecia, psoriasis, or eczema not requiring systemic treatment; hypothyroidism due to autoimmune thyroiditis requiring only stable hormone replacement therapy; type I diabetes mellitus requiring only stable insulin replacement therapy.
  • Other active malignancies within the past 5 years, except for locally curable cancers that have been cured (e.g., basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast), and breast cancer that has not recurred for >3 years after radical surgery.
  • History of interstitial lung disease and/or pneumonitis, or pulmonary hypertension.
  • Symptomatic, untreated, or clinically unstable brain metastases or leptomeningeal metastases.
  • Hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg) or diabetes that remains poorly controlled despite standard treatment; uncontrolled or symptomatic arrhythmia.
  • Thromboembolic events (e.g., cerebrovascular accident, including transient ischemic attack, cerebral hemorrhage, cerebral infarction, or pulmonary embolism) within 6 months before the start of study treatment.
  • Myocardial infarction, severe/unstable angina pectoris, or symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV) within the past 12 months.
  • HIV-positive patients; HBsAg-positive with HBV DNA ≥2000 IU/mL or ≥10⁴ copies/mL; HCV antibody-positive with detectable HCV RNA.
  • Participation in another clinical trial within the previous 60 days or during the study treatment period.
  • Any other condition that, in the investigator's judgment, may interfere with the conduct of the study or the interpretation of the results. Other circumstances deemed by the investigator to make the patient unsuitable for enrollment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

jin li contact

021-64175590-88503

fudanlijin@163.com

China1 site

  • Fudan university cancer hospital

    Shanghai

    jin li, 021-64175590-88503, fudanlijin@163.com

Other trials in China

About this study

Official title: Iparomlimab and Tovorilimab (QL1706) Combined With Bevacizumab and Chemotherapy as Neoadjuvant Therapy for Advanced Ovarian Cancer: A Prospective, Single-Arm, Phase II Study

This is a single-center, single-arm clinical study to evaluate the efficacy and safety of iparomlimab and tovorilimab (QL1706) combined with paclitaxel, carboplatin, and bevacizumab as neoadjuvant therapy for advanced ovarian cancer.

Conditions
Ovarian Cancers
Being tested
Iparomlimab and Tuvonralimab Injection + Bevacizumab + Paclitaxel + Carboplatin
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Iparomlimab and Tuvonralimab Injection + Bevacizumab + Paclitaxel + CarboplatinDrug

    Paclitaxel: 135~175 mg/m², IV, on day 1, every 3 weeks (q3w).

    Carboplatin: AUC 5, IV, on day 1, every 3 weeks (q3w).

    Iparomlimab and Tuvonralimab (QL1706): 5 mg/kg, IV infusion over at least 30 minutes on day 1, repeated every 3 weeks.

    Bevacizumab: 7.5mg/kg, IV infusion over 30-90 minutes on day 1, every 3 weeks (q3w).

Study groups in NCT07663513
Study groupRoleWhat they receive
Iparomlimab and Tuvoraleimab injection+Bevacizumab+Paclitaxel + CarboplatinExperimentalNot described
Receives: Drug: Iparomlimab and Tuvonralimab Injection + Bevacizumab + Paclitaxel + Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. R0 resection rate

    Defined as the percentage of subjects who achieve complete resection (R0) after receiving neoadjuvant therapy.

    Measured: up to 2 years

Secondary outcomes (5)

  1. Objective response rate (ORR)

    Defined as the percentage of subjects achieving complete response (CR) or partial response (PR).

    Measured: up to 2 years

  2. pathological complete response (pCR)

    Histological examination of the entire surgically resected specimen after neoadjuvant therapy confirms the absence of viable tumor cells on all slides and negative lymph node metastasis.

    Measured: up to 2 years

  3. Progression-Free Survival (PFS)

    Defined as the time from enrollment to the date of first documented tumor progression (as assessed RECIST v1.1 criteria, regardless of whether treatment is continued) or death from any cause, whichever occurs first.

    Measured: up to 2 years

  4. Overall Survival (OS)

    Defined as the time from the initiation of treatment until death from any cause.

    Measured: up to 2 years

  5. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2026
  2. Study startJul 2026 (estimated)
  3. Primary completionApr 2029 (estimated)
  4. Study completionApr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07663513
Sponsor's protocol ID
QIBA-OV-neo-01
Status last verified
Jun 2026
First submitted
17 Jun 2026
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Iparomlimab and Tuvonralimab Injection + Bevacizumab + Paclitaxel + Carboplatin in people with Ovarian Cancers, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact jin li (021-64175590-88503, fudanlijin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

R0 resection rate (time frame: up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07663513.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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