Locally Advanced Cervical CancerPhase 2NICE-CCNCT07055399
Neoadjuvant Iparomlimab and Tuvonralimab Plus Chemotherapy-eclipse for Locally Advanced Cervical Cancer (NICE-CC)
A Phase 2 study testing neoadjuvant chemo-immunotherapy: Iparomlimab and tuvonralimab plus cisplatin,nab-paclitaxel for 1 cycle and Iparomlimab and tuvonralimab for 2 cycles in people with Locally Advanced Cervical Cancer, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
Locally advanced cervical cancer (LACC) remains a significant global health concern with limited treatment options. Recent advancements suggest that using neoadjuvant anti-PD-1 inhibitors in combination with chemotherapy, followed by radical surgery, may be an effective treatment strategy for patients with… 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?
- neoadjuvant chemo-immunotherapy: Iparomlimab and tuvonralimab plus cisplatin,nab-paclitaxel for 1 cycle and Iparomlimab and tuvonralimab for 2 cycles
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2025to 1 Sep 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1、Written informed consent
- 2、18-70 years old
- 3、Adequate organ function and ECOG of 0 ~1
- 4、Without systemic therapy at the time of enrollment
- 5、FIGO 2018 stage IB3, IIA2, or IIIC1r
- 6、Histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
Show all 15Show fewer
- 7、Measurable lesions could be defined by RECIST v1.1
- 8、Willing to get blood/ tumor tissue tested
- 9、Patients who observed the rules about the scheduled visit, study schedule, and medical examination
- 10、The function of major organs is normal, and the following criteria are met:
- 10.1 Blood routine examination must meet: (no blood transfusion within 14 days)
- Hb≥90g/L:
- ANC≥1.5x10^9/L; PLT≥100x10^9/L;
- 10.2 The biochemical examination must meet the following standards BIL < 1.5 × ULN; ALT and AST < 2.5xULN; ALB≥ 28 g/L
- 11、Patients who are willing and able to comply with visiting arrangements, treatment plans, laboratory tests, and other research procedures.
Who cannot join
- 1、History of other malignancies within 3 years
- 2、Participate in other clinical trials at the same time
- 3、Active autoimmune disease, which needs systemic therapy
- 4、Uncontrolled infection, which needs systemic therapy
- 5、History of allogeneic tissue/solid organ transplant
- 6、Serious illness, such as severe mental disorders, cardiac disease, coagulation disorders, digestive system disease, etc
Show all 10Show fewer
- 7、Active HBV, HCV, or HIV infection
- 8、Pregnant or lactating female patients
- 9、Drug or alcohol abuse
- 10、 Unable or unwilling to sign the informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Yang Sun, PHD, 86+15959028989, sunyang@fjzlhospital.com
Yang Sun, PHD
About this study
Official title: Neoadjuvant Therapy of Iparomlimab and Tuvonralimab Combined With Chemotherapy-eclipse for Locally Advanced Cervical Cancer：A Single-arm, Open-label, Phase II Trial
Locally advanced cervical cancer (LACC) remains a significant global health concern with limited treatment options. Recent advancements suggest that using neoadjuvant anti-PD-1 inhibitors in combination with chemotherapy, followed by radical surgery, may be an effective treatment strategy for patients with PD-L1-positive LACC. This study aims to evaluate the efficacy and safety of preoperative treatment with iparomlimab and tuvonralimab-a bifunctional PD-1/CTLA-4 dual blocker-combined with chemotherapy for LACC.
Read the detailed description
A total of 43 patients with FIGO 2018 stages IB3, IIA2, IIB, or IIIC1r will receive a combination treatment consisting of iparomlimab and tuvonralimab (5 mg/kg administered intravenously), cisplatin (75-80 mg/m², intravenously), and nab-paclitaxel (260 mg/m², intravenously) for one cycle. Following this, patients will receive two additional cycles of iparomlimab and tuvonralimab at the same dosage of 5 mg/kg, administered at three-week intervals. After completing three cycles of neoadjuvant treatment, patients who show a complete response (CR) or partial response (PR) will undergo radical surgery. The decision regarding subsequent adjuvant therapy will be guided by the NCCN guidelines. In contrast, patients with stable or progressive disease will proceed to concurrent chemoradiotherapy (CCRT).
- Conditions
- Locally Advanced Cervical Cancer
- Being tested
- neoadjuvant chemo-immunotherapy: Iparomlimab and tuvonralimab plus cisplatin,nab-paclitaxel for 1 cycle and Iparomlimab and tuvonralimab for 2 cycles
- Keywords
- Cervical Cancer, neoadjuvant, chemo-immunotherapy, iparomlimab and tuvonralimab;
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant chemo-immunotherapy: Iparomlimab and tuvonralimab plus cisplatin,nab-paclitaxel for 1 cycle and Iparomlimab and tuvonralimab for 2 cyclesDrug
Neoadjuvant chemo-immunotherapy: Iparomlimab and tuvonralimab, cisplatin, and nab-paclitaxel for 1 cycle, then Iparomlimab and tuvonralimab continued for 2 cycles at 3-week intervals. Details:
Iparomlimab and tuvonralimab 5 mg/kg, IV infusion, Q3W for 3 cycles Cisplatin：75-80 mg/m2, IV infusion, (cycle 1) Nab-paclitaxel 260 mg/m2，30min，IV infusion,(cycle 1)
| Study group | Role | What they receive |
|---|---|---|
| Study group : iparomlimab and tuvonralimab plus nab-paclitaxel, cisplatin | Experimental | Participants will receive iparomlimab and tuvonralimab at a dose of 5 mg/kg, nab-paclitaxel at 260 mg/m², and cisplatin at 75-80 mg/m², all administered intravenously on day 1. After three weeks, participants will continue with only iparomlimab and tuvonralimab(5 mg/kg) for two additional cycles at an interval of 3 weeks. Receives: Drug: neoadjuvant chemo-immunotherapy: Iparomlimab and tuvonralimab plus cisplatin,nab-paclitaxel for 1 cycle and Iparomlimab and tuvonralimab for 2 cycles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR)
Pathological complete response（pCR） is defined as the absence of viable tumor cells by surgery
Measured: From enrollment to the end of surgery at 3 months
Secondary outcomes (5)
Objective response rate (ORR)
ORR is defined as the proportion of patients who achieve either a complete or partial response, as assessed by two experienced medical oncologists according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: From enrollment to the end of surgery at 3 months
Event-free survival (EFS)
EFS is defined as the time from initial treatment to the date of disease progression that prevents definitive surgery, local or distant recurrence, occurrence of a second primary cancer, or death from any cause, whichever occurs first.
Measured: Through the study completion, an average of 2 year
Primary pathological response (MPR)
MPR is defined as having no more than 10% viable tumor by surgery.
Measured: From enrollment to the end of surgery at 3 months
Disease-free survival (DFS)
DFS is the interval from the initial treatment to the first occurrence of locoregional failure, distant metastasis, or death from any cause.
Measured: Through the study completion, an average of 2 year
Adverse events
Incidence of Treatment-Emergent Adverse Events, Including adverse events and complications. Incidence of adverse events using CTCAE 5.0; grade 3 treatment-related adverse events and higher-grade will be reported
Measured: During the treatment（12months）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start21 Aug 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- The iparomlimab and tuvonralimab at a dosage of 5 mg/kg administered intravenously, along with cisplatin (75-80 mg/m², intravenously) and nab-paclitaxel (260 mg/m², intravenously) for one cycle. Then, two additional cycles (interval of 3 weeks) of iparomlimab and tuvonralimab (5 mg/kg, intravenously) were followed.
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Collaborators
- Jiangsu Cancer Institute & Hospital, Fuzhou University Affiliated Provincial Hospital, First Affiliated Hospital of Fujian Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055399
- Sponsor's protocol ID
- NICE-CC trial
- Acronym
- NICE-CC
- Status last verified
- Sep 2025
- First submitted
- 17 Apr 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not yet decided
Publications
Wu X, Sun Y, Yang H, Wang J, Lou H, Li D, Wang K, Zhang H, Wu T, Li Y, Wang C, Li G, Wang Y, Li D, Tang Y, Pan M, Cai H, Wang W, Yang B, Qian H, Tian Q, Yao D, Cheng Y, Wei B, Li X, Wang T, Hao M, Wang X, Wang T, Ran J, Zhu H, Zhu L, Liu X, Li Y, Chen L, Li Q, Yan X, Wang F, Cai H, Zhang Y, Liang Z, Liu F, Huang Y, Xia B, Qu P, Zhu G, Chen Y, Song K, Sun M, Chen Z, Zhou Q, Hu L, Abulizi G, Guo H, Liao S, Ye Y, Yan P, Tang Q, Sun G, Liu T, Lu D, Hu M, Wang ZM, Li B, Xia M. Cadonilimab plus platinum-based chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer (COMPASSION-16): a randomised, double-blind, placebo-controlled phase 3 trial in China. Lancet. 2024 Oct 26;404(10463):1668-1676. doi: 10.1016/S0140-6736(24)02135-4. Epub 2024 Oct 16.
PubMed 39426385Nederlof I, Isaeva OI, de Graaf M, Gielen RCAM, Bakker NAM, Rolfes AL, Garner H, Boeckx B, Traets JJH, Mandjes IAM, de Maaker M, van Brussel T, Chelushkin M, Champanhet E, Lopez-Yurda M, van de Vijver K, van den Berg JG, Hofland I, Klioueva N, Mann RM, Loo CE, van Duijnhoven FH, Skinner V, Luykx S, Kerver E, Kalashnikova E, van Dongen MGJ, Sonke GS, Linn SC, Blank CU, de Visser KE, Salgado R, Wessels LFA, Drukker CA, Schumacher TN, Horlings HM, Lambrechts D, Kok M. Neoadjuvant nivolumab or nivolumab plus ipilimumab in early-stage triple-negative breast cancer: a phase 2 adaptive trial. Nat Med. 2024 Nov;30(11):3223-3235. doi: 10.1038/s41591-024-03249-3. Epub 2024 Sep 16.
PubMed 39284953Keam SJ. Iparomlimab and Tuvonralimab: First Approval. Drugs. 2025 May;85(5):699-706. doi: 10.1007/s40265-025-02160-6. Epub 2025 Apr 1.
PubMed 40167968Li K, Chen J, Hu Y, Wang YZ, Shen Y, Chen G, Peng W, Fang Z, Xia B, Chen X, Song K, Wang Y, Zou D, Wang YC, Han Y, Feng X, Yuan J, Guo S, Meng X, Feng C, Chen Y, Yang J, Fan J, Wang J, Ai J, Ma D, Sun C. Neoadjuvant chemotherapy plus camrelizumab for locally advanced cervical cancer (NACI study): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2024 Jan;25(1):76-85. doi: 10.1016/S1470-2045(23)00531-4. Epub 2023 Dec 1.
PubMed 38048802Miriyala R, Mahantshetty U, Maheshwari A, Gupta S. Neoadjuvant chemotherapy followed by surgery in cervical cancer: past, present and future. Int J Gynecol Cancer. 2022 Mar;32(3):260-265. doi: 10.1136/ijgc-2021-002531.
PubMed 35256411Abu-Rustum NR, Yashar CM, Arend R, Barber E, Bradley K, Brooks R, Campos SM, Chino J, Chon HS, Crispens MA, Damast S, Fisher CM, Frederick P, Gaffney DK, Gaillard S, Giuntoli R, Glaser S, Holmes J, Howitt BE, Lea J, Mantia-Smaldone G, Mariani A, Mutch D, Nagel C, Nekhlyudov L, Podoll M, Rodabaugh K, Salani R, Schorge J, Siedel J, Sisodia R, Soliman P, Ueda S, Urban R, Wyse E, McMillian NR, Aggarwal S, Espinosa S. NCCN Guidelines(R) Insights: Cervical Cancer, Version 1.2024. J Natl Compr Canc Netw. 2023 Dec;21(12):1224-1233. doi: 10.6004/jnccn.2023.0062.
PubMed 38081139Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
PubMed 38572751Lin J, Wu Q, Liu B, He H, Guo X, Li L, Jiang Y, Huang Y, Lin Y, He T, Zheng X, Li S, Chen L, Lin C, Li E, Zhou S, Sun Y. Neoadjuvant therapy of iparomlimab and tuvonralimab combined with chemotherapy-extenuated for locally advanced cervical cancer (NICE-CC): an investigator-initiated, multicentre, open-label, phase II trial. J Gynecol Oncol. 2026 Jul;37(4):e70. doi: 10.3802/jgo.2026.37.e70. Epub 2026 Feb 9.
PubMed 41775252
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Therapy of Iparomlimab and Tuvonralimab Combined With Chemotherapy-eclipse for Locally Advanced Cervical Cancer：A Single-arm, Open-label, Phase II Trial
- ClinicalTrials.gov ID
- NCT07055399
- Acronym / sponsor ID
- NICE-CC / NICE-CC trial
- Conditions
- Locally Advanced Cervical Cancer
- Keywords
- Cervical Cancer, neoadjuvant, chemo-immunotherapy, iparomlimab and tuvonralimab;
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Collaborators
- Jiangsu Cancer Institute & Hospital, Fuzhou University Affiliated Provincial Hospital, First Affiliated Hospital of Fujian Medical University
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Locally advanced cervical cancer (LACC) remains a significant global health concern with limited treatment options. Recent advancements suggest that using neoadjuvant anti-PD-1 inhibitors in combination with chemotherapy, followed by radical surgery, may be an effective treatment strategy for patients with PD-L1-positive LACC. This study aims to evaluate the efficacy and safety of preoperative treatment with iparomlimab and tuvonralimab-a bifunctional PD-1/CTLA-4 dual blocker-combined with chemotherapy for LACC.
Detailed description
A total of 43 patients with FIGO 2018 stages IB3, IIA2, IIB, or IIIC1r will receive a combination treatment consisting of iparomlimab and tuvonralimab (5 mg/kg administered intravenously), cisplatin (75-80 mg/m², intravenously), and nab-paclitaxel (260 mg/m², intravenously) for one cycle. Following this, patients will receive two additional cycles of iparomlimab and tuvonralimab at the same dosage of 5 mg/kg, administered at three-week intervals. After completing three cycles of neoadjuvant treatment, patients who show a complete response (CR) or partial response (PR) will undergo radical surgery. The decision regarding subsequent adjuvant therapy will be guided by the NCCN guidelines. In contrast, patients with stable or progressive disease will proceed to concurrent chemoradiotherapy (CCRT).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The iparomlimab and tuvonralimab at a dosage of 5 mg/kg administered intravenously, along with cisplatin (75-80 mg/m², intravenously) and nab-paclitaxel (260 mg/m², intravenously) for one cycle. Then, two additional cycles (interval of 3 weeks) of iparomlimab and tuvonralimab (5 mg/kg, intravenously) were followed.
| Arm | Type | Receives |
|---|---|---|
| Study group : iparomlimab and tuvonralimab plus nab-paclitaxel, cisplatin | Experimental | Drug: neoadjuvant chemo-immunotherapy: Iparomlimab and tuvonralimab plus cisplatin,nab-paclitaxel for 1 cycle and Iparomlimab and tuvonralimab for 2 cyclesParticipants will receive iparomlimab and tuvonralimab at a dose of 5 mg/kg, nab-paclitaxel at 260 mg/m², and cisplatin at 75-80 mg/m², all administered intravenously on day 1. After three weeks, participants will continue with only iparomlimab and tuvonralimab(5 mg/kg) for two additional cycles at an interval of 3 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 1、Written informed consent
- 2、18-70 years old
- 3、Adequate organ function and ECOG of 0 ~1
- 4、Without systemic therapy at the time of enrollment
- 5、FIGO 2018 stage IB3, IIA2, or IIIC1r
Key exclusion criteria (10 listed)
- 1、History of other malignancies within 3 years
- 2、Participate in other clinical trials at the same time
- 3、Active autoimmune disease, which needs systemic therapy
- 4、Uncontrolled infection, which needs systemic therapy
- 5、History of allogeneic tissue/solid organ transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neoadjuvant chemo-immunotherapy: Iparomlimab and tuvonralimab plus cisplatin,nab-paclitaxel for 1 cycle and Iparomlimab and tuvonralimab for 2 cyclesNeoadjuvant chemo-immunotherapy: Iparomlimab and tuvonralimab, cisplatin, and nab-paclitaxel for 1 cycle, then Iparomlimab and tuvonralimab continued for 2 cycles at 3-week intervals. Details: Iparomlimab and tuvonralimab 5 mg/kg, IV infusion, Q3W for 3 cycles Cisplatin：75-80 mg/m2, IV infusion, (cycle 1) Nab-paclitaxel 260 mg/m2，30min，IV infusion,(cycle 1) | Drug | Study group : iparomlimab and tuvonralimab plus nab-paclitaxel, cisplatin |
Primary outcome
Pathological complete response (pCR)
Time frame: From enrollment to the end of surgery at 3 months
Pathological complete response（pCR） is defined as the absence of viable tumor cells by surgery
5 secondary outcomes
Objective response rate (ORR)
Time frame: From enrollment to the end of surgery at 3 months
Event-free survival (EFS)
Time frame: Through the study completion, an average of 2 year
Primary pathological response (MPR)
Time frame: From enrollment to the end of surgery at 3 months
Disease-free survival (DFS)
Time frame: Through the study completion, an average of 2 year
Adverse events
Time frame: During the treatment（12months）
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Background: PubMed 39426385Wu X, Sun Y, Yang H, Wang J, Lou H, Li D, Wang K, Zhang H, Wu T, Li Y, Wang C, Li G, Wang Y, Li D, Tang Y, Pan M, Cai H, Wang W, Yang B, Qian H, Tian Q, Yao D, Cheng Y, Wei B, Li X, Wang T, Hao M, Wang X, Wang T, Ran J, Zhu H, Zhu L, Liu X, Li Y, Chen L, Li Q, Yan X, Wang F, Cai H, Zhang Y, Liang Z, Liu F, Huang Y, Xia B, Qu P, Zhu G, Chen Y, Song K, Sun M, Chen Z, Zhou Q, Hu L, Abulizi G, Guo H, Liao S, Ye Y, Yan P, Tang Q, Sun G, Liu T, Lu D, Hu M, Wang ZM, Li B, Xia M. Cadonilimab plus platinum-based chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer (COMPASSION-16): a randomised, double-blind, placebo-controlled phase 3 trial in China. Lancet. 2024 Oct 26;404(10463):1668-1676. doi: 10.1016/S0140-6736(24)02135-4. Epub 2024 Oct 16.
- Background: PubMed 39284953Nederlof I, Isaeva OI, de Graaf M, Gielen RCAM, Bakker NAM, Rolfes AL, Garner H, Boeckx B, Traets JJH, Mandjes IAM, de Maaker M, van Brussel T, Chelushkin M, Champanhet E, Lopez-Yurda M, van de Vijver K, van den Berg JG, Hofland I, Klioueva N, Mann RM, Loo CE, van Duijnhoven FH, Skinner V, Luykx S, Kerver E, Kalashnikova E, van Dongen MGJ, Sonke GS, Linn SC, Blank CU, de Visser KE, Salgado R, Wessels LFA, Drukker CA, Schumacher TN, Horlings HM, Lambrechts D, Kok M. Neoadjuvant nivolumab or nivolumab plus ipilimumab in early-stage triple-negative breast cancer: a phase 2 adaptive trial. Nat Med. 2024 Nov;30(11):3223-3235. doi: 10.1038/s41591-024-03249-3. Epub 2024 Sep 16.
- Background: PubMed 40167968Keam SJ. Iparomlimab and Tuvonralimab: First Approval. Drugs. 2025 May;85(5):699-706. doi: 10.1007/s40265-025-02160-6. Epub 2025 Apr 1.
- Background: PubMed 38048802Li K, Chen J, Hu Y, Wang YZ, Shen Y, Chen G, Peng W, Fang Z, Xia B, Chen X, Song K, Wang Y, Zou D, Wang YC, Han Y, Feng X, Yuan J, Guo S, Meng X, Feng C, Chen Y, Yang J, Fan J, Wang J, Ai J, Ma D, Sun C. Neoadjuvant chemotherapy plus camrelizumab for locally advanced cervical cancer (NACI study): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2024 Jan;25(1):76-85. doi: 10.1016/S1470-2045(23)00531-4. Epub 2023 Dec 1.
- Background: PubMed 35256411Miriyala R, Mahantshetty U, Maheshwari A, Gupta S. Neoadjuvant chemotherapy followed by surgery in cervical cancer: past, present and future. Int J Gynecol Cancer. 2022 Mar;32(3):260-265. doi: 10.1136/ijgc-2021-002531.
- Background: PubMed 38081139Abu-Rustum NR, Yashar CM, Arend R, Barber E, Bradley K, Brooks R, Campos SM, Chino J, Chon HS, Crispens MA, Damast S, Fisher CM, Frederick P, Gaffney DK, Gaillard S, Giuntoli R, Glaser S, Holmes J, Howitt BE, Lea J, Mantia-Smaldone G, Mariani A, Mutch D, Nagel C, Nekhlyudov L, Podoll M, Rodabaugh K, Salani R, Schorge J, Siedel J, Sisodia R, Soliman P, Ueda S, Urban R, Wyse E, McMillian NR, Aggarwal S, Espinosa S. NCCN Guidelines(R) Insights: Cervical Cancer, Version 1.2024. J Natl Compr Canc Netw. 2023 Dec;21(12):1224-1233. doi: 10.6004/jnccn.2023.0062.
- Background: PubMed 38572751Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
- Derived from this study: PubMed 41775252Lin J, Wu Q, Liu B, He H, Guo X, Li L, Jiang Y, Huang Y, Lin Y, He T, Zheng X, Li S, Chen L, Lin C, Li E, Zhou S, Sun Y. Neoadjuvant therapy of iparomlimab and tuvonralimab combined with chemotherapy-extenuated for locally advanced cervical cancer (NICE-CC): an investigator-initiated, multicentre, open-label, phase II trial. J Gynecol Oncol. 2026 Jul;37(4):e70. doi: 10.3802/jgo.2026.37.e70. Epub 2026 Feb 9.
- Individual participant dataSharing planned: No. Not yet decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing neoadjuvant chemo-immunotherapy: Iparomlimab and tuvonralimab plus cisplatin,nab-paclitaxel for 1 cycle and Iparomlimab and tuvonralimab for 2 cycles in people with Locally Advanced Cervical Cancer, run by Fujian Cancer 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 15 inclusion and 10 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 11 Sep 2025. 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 Yang Sun, PHD (86-15959028989, sunyang@fjzlhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (pCR) (time frame: From enrollment to the end of surgery at 3 months). 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 NCT07055399, which also lists 8 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 11 Sep 2025.