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Locally Advanced Cervical CancerPhase 2NCT07876154

Iparomlimab/Tuvonralimab Combined With Nab-paclitaxel and Cisplatin as Neoadjuvant Therapy for Locally Advanced Cervical Cancer

A Phase 2 study testing Iparomlimab/Tuvonralimab, nab-paclitaxel and Cisplatin in people with Locally Advanced Cervical Cancer, run by Xijing Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Locally Advanced Cervical Cancer
What is being tested?
Iparomlimab/Tuvonralimab, nab-paclitaxel and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteChina
Study dates
25 Sep 2025to Jun 2028
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 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients aged between 18 and 70 years (inclusive);
  • Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;
  • Previously untreated IB3 or IIA2 stage cervical cancer according to the FIGO 2018 staging system;
  • At least one measurable lesion based on RECIST version 1.1 criteria, with MRI-confirmed lymph node diameter less than 1.5 cm;
  • 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:
Show all 9Show fewer
  • 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;
  • 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

Who cannot join

  • 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.

Trial locations and contacts

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

Shujuan Liu, MD contact

+86 13991850015

hanliu@fmmu.edu.cn

Xiaohui Lv, MD contact

+86 13669293257

lvxiaohuiss@126.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Airforce Medical University

    Xi'an, Shaanxi, 710032

    Shujuan Liu, MD, +86 13991850015, hanliu@fmmu.edu.cn

    Xiaohui Lv, MD, +86 13669293257, lvxiaohuiss@126.com

    Recruiting

Other trials in China

About this study

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

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?

Read more

There is no comparison group in this single-arm study.

Participants will:

  • Receive neoadjuvant treatment with Iparomlimab/Tuvonralimab, albumin-bound paclitaxel and cisplatin
  • Undergo radical surgery after completion of neoadjuvant therapy
  • Receive scheduled imaging, blood and tissue biomarker tests
  • Be followed up regularly for survival and safety assessment.
Being tested
Iparomlimab/Tuvonralimab, nab-paclitaxel, Cisplatin, Carboplatin (AUC 5)
Keywords
Locally advanced cervical cancer, Neoadjuvant therapy, Immunotherapy, Chemotherapy, Iparomlimab/Tuvonralimab

What participants receive

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

  • Iparomlimab/TuvonralimabBiological

    Also called QL1706

    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.

  • nab-paclitaxelDrug

    260 mg/m², intravenous infusion over 30 minutes on Day 1 of each 3-week cycle, for total 3 cycles.

  • CisplatinDrug

    75 mg/m², intravenous infusion on Day 1 of each 3-week cycle, for total 3 cycles.

  • Carboplatin (AUC 5)Drug

    AUC 5, intravenous infusion on Day 1 of each 3-week cycle, used as substitute for patients with cisplatin intolerance.

Study groups in NCT07876154
Study groupRoleWhat they receive
Iparomlimab/Tuvonralimab plus nab-paclitaxel and cisplatinExperimentalnab-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
Receives: Biological: Iparomlimab/Tuvonralimab; Drug: nab-paclitaxel; Drug: Cisplatin; Drug: Carboplatin (AUC 5)

What is being measured

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

  1. 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.

    Measured: Within 2 weeks after definitive radical surgery

Secondary outcomes (5)

  1. 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.

    Measured: After completion of 3 cycles of neoadjuvant therapy

  2. Progression-free survival (PFS)

    Defined as the time from treatment initiation to any event, including disease progression, recurrence, or death from any cause.

    Measured: Up to 36 months after radical surgery

  3. Overall survival (OS)

    Defined as the time from treatment initiation to death from any cause.

    Measured: Up to 36 months after radical surgery

  4. 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.

    Measured: From first study treatment administration to 30 days after the last dose of study drugs

  5. 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.

    Measured: baseline, pre-surgery,and immediately after the surgery

Timeline

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

  1. First posted15 Oct 2026
  2. Study start25 Sep 2025
  3. Primary completionJul 2027 (estimated)
  4. Study completionJun 2028 (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
Model description
Single-arm, non-randomized, open-label trial. All enrolled patients receive the same neoadjuvant combination regimen.
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07876154
Sponsor's protocol ID
XJLL-KY-20252285
Other IDs
ChiCTR2500105872
Status last verified
Oct 2026
First submitted
5 Oct 2026
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Monk BJ, Colombo N, Tewari KS, Dubot C, Caceres MV, Hasegawa K, Shapira-Frommer R, Salman P, Yanez E, Gumus M, Olivera Hurtado de Mendoza M, Samouelian V, Castonguay V, Arkhipov A, Tekin C, Li K, Keefe SM, Lorusso D; KEYNOTE-826 Investigators. First-Line Pembrolizumab + Chemotherapy Versus Placebo + Chemotherapy for Persistent, Recurrent, or Metastatic Cervical Cancer: Final Overall Survival Results of KEYNOTE-826. J Clin Oncol. 2023 Dec 20;41(36):5505-5511. doi: 10.1200/JCO.23.00914. Epub 2023 Nov 1.

    PubMed 37910822

  • N. Liu, et al. Efficacy and safety QL1706 plus paclitaxel and cisplatin/carboplatin +/- bevacizumab (Bev) as 1L treatment in recurrent or metastatic cervical cancer (r/mCC): A single-arm, multicenter phase II study . 2023 ESMO Abstract 743MO

  • Chen J, Han Y, Hu Y, Feng X, Meng X, Guo S, Sun C, Chen G, Li K. Neoadjuvant camrelizumab plus chemotherapy for locally advanced cervical cancer (NACI Study): a study protocol of a prospective, single-arm, phase II trial. BMJ Open. 2023 May 30;13(5):e067767. doi: 10.1136/bmjopen-2022-067767.

    PubMed 37253491

  • Katsumata N, Yoshikawa H, Kobayashi H, Saito T, Kuzuya K, Nakanishi T, Yasugi T, Yaegashi N, Yokota H, Kodama S, Mizunoe T, Hiura M, Kasamatsu T, Shibata T, Kamura T; Japan Clinical Oncology Group. Phase III randomised controlled trial of neoadjuvant chemotherapy plus radical surgery vs radical surgery alone for stages IB2, IIA2, and IIB cervical cancer: a Japan Clinical Oncology Group trial (JCOG 0102). Br J Cancer. 2013 May 28;108(10):1957-63. doi: 10.1038/bjc.2013.179. Epub 2013 May 2.

    PubMed 23640393

  • Cosgrove CM, Salani R. Ovarian effects of radiation and cytotoxic chemotherapy damage. Best Pract Res Clin Obstet Gynaecol. 2019 Feb;55:37-48. doi: 10.1016/j.bpobgyn.2018.07.008. Epub 2018 Jul 26.

    PubMed 30166215

  • Rose PG, Bundy BN, Watkins EB, Thigpen JT, Deppe G, Maiman MA, Clarke-Pearson DL, Insalaco S. Concurrent cisplatin-based radiotherapy and chemotherapy for locally advanced cervical cancer. N Engl J Med. 1999 Apr 15;340(15):1144-53. doi: 10.1056/NEJM199904153401502.

    PubMed 10202165

  • Whitney CW, Sause W, Bundy BN, Malfetano JH, Hannigan EV, Fowler WC Jr, Clarke-Pearson DL, Liao SY. Randomized comparison of fluorouracil plus cisplatin versus hydroxyurea as an adjunct to radiation therapy in stage IIB-IVA carcinoma of the cervix with negative para-aortic lymph nodes: a Gynecologic Oncology Group and Southwest Oncology Group study. J Clin Oncol. 1999 May;17(5):1339-48. doi: 10.1200/JCO.1999.17.5.1339.

    PubMed 10334517

  • Peters WA 3rd, Liu PY, Barrett RJ 2nd, Stock RJ, Monk BJ, Berek JS, Souhami L, Grigsby P, Gordon W Jr, Alberts DS. Concurrent Chemotherapy and Pelvic Radiation Therapy Compared With Pelvic Radiation Therapy Alone as Adjuvant Therapy After Radical Surgery in High-Risk Early-Stage Cancer of the Cervix. J Clin Oncol. 2023 Oct 10;41(29):4605-4612. doi: 10.1200/JCO.22.02769.

    PubMed 37797409

  • Pang SS, Murphy M, Markham MJ. Current Management of Locally Advanced and Metastatic Cervical Cancer in the United States. JCO Oncol Pract. 2022 Jun;18(6):417-422. doi: 10.1200/OP.21.00795. Epub 2022 Mar 14.

    PubMed 35286157

  • Gu X, Sun G, Zheng R, Zhang S, Zeng H, Sun K, Wang S, Chen R, Wei W, He J. Incidence and mortality of cervical cancer in China in 2015. J Natl Cancer Cent. 2022 Feb 3;2(2):70-77. doi: 10.1016/j.jncc.2022.01.002. eCollection 2022 Jun.

    PubMed 39034952

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Iparomlimab/Tuvonralimab, nab-paclitaxel and Cisplatin in people with Locally Advanced Cervical Cancer, run by Xijing Hospital 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 9 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 15 Oct 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 Shujuan Liu, MD (+86 13991850015, hanliu@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response (pCR) rate (time frame: Within 2 weeks after definitive radical surgery). 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 NCT07876154, which also lists 10 linked publications.

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 15 Oct 2026.

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