CClinicalTrials.gg
Not yet recruitingNCT07663513Updated Jun 23, 2026

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

A Phase 2 interventional study of Iparomlimab and Tuvonralimab Injection + Bevacizumab + Paclitaxel + Carboplatin in Ovarian Cancers, sponsored by 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 2026-06-23.

Sponsored by Fudan University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Ovarian Cancers

Browse trials for

03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's planned enrollment of 36 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

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

Study arms

  • Experimental
    Iparomlimab and Tuvoraleimab injection+Bevacizumab+Paclitaxel + Carboplatin

    Drug: Iparomlimab and Tuvonralimab Injection + Bevacizumab + Paclitaxel + Carboplatin

Interventions

  • DrugIparomlimab and Tuvonralimab Injection + Bevacizumab + Paclitaxel + Carboplatin

    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).

06

What researchers measure

Primary outcomes

  1. R0 resection rate

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

    Time frame: up to 2 years

Secondary outcomes

  1. Objective response rate (ORR)

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

    Time frame: 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.

    Time frame: 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.

    Time frame: up to 2 years

  4. Overall Survival (OS)

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

    Time frame: 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

    Time frame: up to 2 years

07

Study locations

1 site
  • Fudan university cancer hospital
    Shanghai, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07663513
Lead sponsor
Fudan University
Responsible party
Jin LI (Chief Physician, Fudan University) — Principal investigator
First posted
Jun 23, 2026
Start date
Jul 2026 (estimated)
Primary completion
Apr 2029 (estimated)
Completion
Apr 2029 (estimated)
Last update
Jun 23, 2026

Study contacts

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

Oversight

Data monitoring committee
No
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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion