Iparomlimab/Tuvonralimab with nab-paclitaxel and cisplatin as neoadjuvant therapy for locally advanced cervical cancer
Official title: A Single-center, Single-arm, Prospective Clinical Study of the Use of Iparomlimab/Tuvonralimab Combined With Nab-paclitaxel and Cisplatin as Neoadjuvant Therapy for Locally Advanced Cervical Cancer
Run by Xijing Hospital · NCT07876154 · Data updated 2026-11-12
This trial tests whether adding Iparomlimab/Tuvonralimab to nab-paclitaxel and cisplatin before surgery can shrink locally advanced cervical cancer and safely be given to adult women.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | Women only |
| Enrollment | 34 (estimated) |
| Sponsor | Xijing Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, prednisone, Iparomlimab, Tuvonralimab |
| Locations | 1 site (Xi'an, Shaanxi) |
| Status | Recruiting |
| Started | September 25, 2025 |
| Main results expected | July 2027 |
| Study ends | June 2028 |
| Registry record updated | October 15, 2026 |
| Trial ID | NCT07876154 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult women aged 18–70 with histologically confirmed locally advanced cervical cancer (IB3 to IIA2), measurable disease, good performance status, and consent to tumor biomarker testing.
✕Probably not a fit
Patients whose tumors do not respond to the regimen or who experience intolerable toxicity may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a phase 2, single-arm interventional study enrolling adult women with previously untreated, locally advanced cervical cancer. Participants receive neoadjuvant therapy with Iparomlimab/Tuvonralimab plus nab-paclitaxel and cisplatin, followed by radical surgery. The study collects imaging, blood, and tumor tissue to evaluate pathological complete response, objective response rate, progression-free and overall survival, and changes in biomarkers and the tumor immune microenvironment. Safety and tolerability of the combination regimen are also monitored. No comparison group is included in this design.
Why it matters
Potential benefit: If successful, participants may experience tumor reduction before surgery and improved chances for favorable outcomes after treatment.
How similar studies have gone: Previous work in similar neoadjuvant immunotherapy/chemotherapy combinations in gynecologic cancers has shown potential signals of tumor response, but this exact regimen is being studied in a single-arm, exploratory setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Female patients aged between 18 and 70 years (inclusive); 2. Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; 3. Previously untreated IB3 or IIA2 stage cervical cancer according to the FIGO 2018 staging system; 4. At least one measurable lesion based on RECIST version 1.1 criteria, with MRI-confirmed lymph node diameter less than 1.5 cm; 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 6.Patients must provide tumor tissue samples for PD-L1 expression testing, either formalin-fixed paraffin-embedded (FFPE) or fresh tumor tissue; 7\. Laboratory test requirements: 1. Hematology (no blood transfusion, hematopoietic growth factors, or other medications affecting blood counts within 14 days): absolute neutrophil count (ANC) \>= 1.5×10⁹/L; platelet count (PLT) \>= 80×10⁹/L; hemoglobin (HGB) \>= 90 g/L; 2. Biochemistry: serum creatinine \<= 1.5 × upper limit of normal (ULN), or creatinine clearance \>= 60 mL/min calculated using the Cockcroft-Gault formula if \>1.5 × ULN; total bilirubin (TBIL) \<= 1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels within acceptable range. 8\. Female subjects of childbearing potential must have a negative pregnancy test, not be breastfeeding, and must agree to use effective medical contraception from the time of informed consent signing until six months after the last study drug administration; 9. Subjects must voluntarily participate in the study, demonstrate good compliance with planned treatment and follow-up procedures, and be able to understand the study process and willingly sign the informed consent form Exclusion Criteria: 1.Presence of distant metastatic disease; 2.Prior receipt of any anti-cancer therapy, including but not limited to surgery (excluding biopsy), radiation therapy, or systemic treatments such as chemotherapy, immunotherapy, or targeted therapy; 3. Previous treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 or anti-PD-L1 antibodies; 4.Active malignancy within three years prior to first dosing, except for cervical cancer under investigation in this trial or any localized, curable tumors that have received definitive treatment (e.g., completely resected basal cell or squamous cell skin cancer, superficial bladder cancer, or cured in situ cancers such as breast carcinoma in situ); 5.Active autoimmune disease, or history of autoimmune disease within two years before enrollment requiring ongoing systemic treatment. Autoimmune diseases include but are not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, or asthma requiring bronchodilator intervention. However, participants with well-controlled type I diabetes, hypothyroidism managed solely with hormone replacement therapy, non-systemically treated skin conditions (such as vitiligo, psoriasis, or alopecia), or those whose condition is unlikely to recur without external triggers may still be considered for enrollment; 6.Primary immunodeficiency disorder or relevant medical history; 7.Received immunosuppressive agents (e.g., cyclosporine) within 14 days prior to enrollment or require daily systemic corticosteroid use (e.g., \>20 mg/day prednisone or equivalent), except for nasal sprays, inhalers, or other forms of localized steroid therapy; 8.Positive for human immunodeficiency virus antibody (HIV-Ab) or active syphilis infection; positive for hepatitis B surface antigen (HBsAg) with a viral load (HBV-DNA) \>500 IU/mL or \>2500 (units unclear, likely IU/mL.Viral load of hepatitis C virus (HCV-RNA) above the upper limit of normal for the testing facility. (Note: For participants who are positive for hepatitis B surface antigen \[HBsAg\], it is recommended to start antiviral therapy before the first administration of study drugs, using nucleoside analogs such as entecavir or tenofovir disoproxil fumarate.) 9. Active bacterial, fungal, or viral infection within 14 days prior to enrollment requiring intravenous antimicrobial, antifungal, or antiviral treatment. Participants receiving prophylactic anti-infective treatment without clinical signs of active infection at the time of screening may still be considered for inclusion; 10. Active tuberculosis or a history of tuberculosis; 11. History of severe cardiovascular disease within the past six months prior to enrollment, including but not limited to: stable angina classified as III-IV functional class; unstable angina or myocardial infarction; congestive heart failure classified as NYHA III-IV; clinically significant arrhythmias requiring medication (asymptomatic atrial fibrillation patients may be included if ventricular rate is well controlled); serious arterial/venous thromboembolic events such as hemorrhagic stroke, ischemic stroke, deep vein thrombosis, or pulmonary embolism; 12. Uncontrolled hypertension; 13. Interstitial lung disease or a history thereof, or non-infectious pneumonia requiring corticosteroid treatment; 14. Clinically significant hydronephrosis that, in the investigator's judgment, cannot be relieved through nephrostomy or ureteral stent placement; 15. Receipt of or planned administration of live or attenuated vaccines within 28 days before enrollment or during the study period; 16. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation; 17. History of severe allergic reactions to any component of monoclonal antibody formulations, or uncontrolled allergic asthma; 18. Contraindication to or history of severe allergic reaction to nab-paclitaxel, cisplatin, carboplatin, or any ingredient in the immunotherapy agents; 19. Participation in another clinical trial with administration of investigational drug within 28 days prior to enrollment; 20. Clear history of neurological or psychiatric disorders, substance abuse, or drug addiction that cannot be ceased or for which there is documented illicit drug use; 21. Any other condition deemed unsuitable for participation in this study by the investigator.
Where it's running
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The First Affiliated Hospital of Airforce Medical University
Xi'an, Shaanxi, China Recruiting
Study contacts
- Principal investigator: Shujuan Liu, MD — The First Affiliated Hospital of Airforce Medical University
- Study coordinator: Shujuan Liu, MD
- Email: hanliu@fmmu.edu.cn
- Phone: +86 13991850015
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.