A Phase 2 interventional study of Iparomlimab/Tuvonralimab and nab-paclitaxel in Locally Advanced Cervical Cancer, sponsored by Xijing Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Xijing Hospital · Phase 2, Interventional, and Treatment
The goal of this clinical trial is to learn if Iparomlimab/Tuvonralimab combined with nab-paclitaxel and cisplatin as neoadjuvant treatment can treat locally advanced cervical cancer in adult female patients. It will also learn about the safety of this combination regimen. The main questions it aims to answer are:
What is the pathological complete response (pCR) rate after neoadjuvant combination therapy? What are the objective response rate, progression-free survival, overall survival, biomarker changes and tumor immune microenvironment changes in participants receiving this regimen?
There is no comparison group in this single-arm study.
Participants will:
Xijing Hospital is the lead sponsor of 474 studies on the registry; 159 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
7. Laboratory test requirements:
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.
nab-paclitaxel 260 mg/m2 administered intravenously over 30 minutes on Day 1; Cisplatin 75 mg/m2 administered intravenously. If cisplatin is not tolerated, carboplatin (AUC 5, intravenous infusion on Day 1) may be used as an alternative. Iparomlimab/Tuvonralimab Injection 5 mg/kg, IV infusion, Day 1
Biological: Iparomlimab/Tuvonralimab · Drug: nab-paclitaxel · Drug: Cisplatin · Drug: Carboplatin (AUC 5)
Drug page: Iparomlimab/Tuvonralimab
5 mg/kg, intravenous infusion on Day 1 of each 3-week cycle, for a total of 3 cycles. It is a bispecific antibody targeting PD-1 and CTLA-4.
Also known as: QL1706
260 mg/m², intravenous infusion over 30 minutes on Day 1 of each 3-week cycle, for total 3 cycles.
75 mg/m², intravenous infusion on Day 1 of each 3-week cycle, for total 3 cycles.
AUC 5, intravenous infusion on Day 1 of each 3-week cycle, used as substitute for patients with cisplatin intolerance.
Pathological complete response (pCR) rate
The proportion of participants with pathological complete response (pCR), defined as no residual invasive carcinoma in the cervix and pelvic lymph nodes, evaluated by postoperative surgical pathology.
Time frame: Within 2 weeks after definitive radical surgery
Objective response rate (ORR)
The proportion of participants whose Best Overall Response (BOR) is Complete Response (CR) or Partial Response (PR) as assessed according to RECIST version 1.1.
Time frame: After completion of 3 cycles of neoadjuvant therapy
Progression-free survival (PFS)
Defined as the time from treatment initiation to any event, including disease progression, recurrence, or death from any cause.
Time frame: Up to 36 months after radical surgery
Overall survival (OS)
Defined as the time from treatment initiation to death from any cause.
Time frame: Up to 36 months after radical surgery
Treatment-related Adverse Events and Laboratory Abnormalities
Adverse events (AEs) and laboratory abnormalities, including category, incidence, grade (assessed per NCI-CTCAE v5.0), duration, and relationship to study treatment and immunotherapy.
Time frame: From first study treatment administration to 30 days after the last dose of study drugs
Monitoring of immunological biomarkers related to treatment response
Evaluation of tumor immune microenvironment biomarkers, including the quantity of tumor-infiltrating lymphocytes (TILs), the proportion of cytotoxic T cells (CD3+CD8+/CD3+), the proportion of regulatory T cells (Treg, CD3+FoxP3+CD8-/CD3+), the count of effector Treg cells (CD3+CD45RO+FoxP3+CD8-), the quantity of tumor-associated macrophages (TAM), and tertiary lymphoid structures.
Time frame: baseline, pre-surgery,and immediately after the surgery
Plan to share: Yes — De-identified individual participant data supporting primary and secondary efficacy endpoints will be shared. Data include baseline characteristics, treatment records, tumor response assessments, adverse events and survival data.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Within 6 months after the end of the trial, contact the investigator to obtain it
Access criteria: Researchers must submit a formal research proposal and sign a data use agreement approved by the principal investigator before obtaining access to de-identified IPD.
Started Sep 2025 (actual). Primary completion is estimated for Jul 2027, 22 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Iparomlimab/Tuvonralimab · Albumin-Bound Paclitaxel · Cisplatin