AzTrials
AzTrials

Uterine Cervical NeoplasmsNCT07702838

Immunotherapy Combined With Carbon Ion Radiotherapy for Locally Advanced Cervical Cancer

A study testing Carbon ion external beam radiotherapy plus 3 courses of three-dimensional brachytherapy. in people with Uterine Cervical Neoplasms, run by Zhejiang Cancer 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
Search all trials

Trial summary

This study explores the therapeutic effect of carbon ion radiotherapy plus immunotherapy and chemotherapy for locally advanced cervical cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Uterine Cervical Neoplasms
What is being tested?
Carbon ion external beam radiotherapy plus 3 courses of three-dimensional brachytherapy.
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
Jul 2026to Dec 2030
Phase
Interventional
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients aged ≥ 18 years at the time of signing the informed consent form.
  • Histopathologically confirmed diagnosis of cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma).
  • Stage IIB-IVA disease per the 2018 FIGO staging system.
  • Presence of measurable lesions as defined by RECIST version 1.1.
  • Patients reviewed by the carbon ion radiotherapy multidisciplinary team (MDT) with an indication for carbon ion radiotherapy.
  • Patients voluntarily receiving carbon ion radiotherapy at Zhejiang Cancer Hospital and bearing all relevant treatment expenses.
Show all 14Show fewer
  • Complete clinical and imaging data available.
  • Patients willing to participate in the trial and complete questionnaire surveys.
  • Patients willing to participate in the trial and provide biospecimens, including cervical tissue, various body fluid specimens and tissue samples.
  • Patients willing to attend regular standardised outpatient follow-up visits at our hospital.
  • Eastern Cooperative 11. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2.
  • No prior history of surgery, radiotherapy or chemotherapy for cervical cancer.
  • Adequate function of major vital organs (bone marrow, liver, kidney, etc.), with laboratory values meeting the following criteria within 1 week prior to treatment: Absolute neutrophil count (ANC) ≥ 1500/μL; Platelet count ≥ 100,000/μL; Haemoglobin ≥ 9.0 g/dL (or ≥ 5.6 mmol/L); Creatinine clearance ≥ 50 mL/min; Total bilirubin ≤ 1.5 × upper limit of normal (ULN); if total bilirubin > 1.5 × ULN, direct bilirubin shall be ≤ ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; International Normalised Ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (excluding patients receiving anticoagulant therapy within the therapeutic range).
  • Estimated overall survival ≥ 6 months.

Who cannot join

  • Presence of severe concomitant complications (e.g., uncontrolled cardiovascular disease, hypertension, diabetes mellitus, refractory infection, active peptic ulcer, uncontrolled psychiatric disorders, etc.)
  • Concurrent active second primary malignancy.
  • Tumour invasion of the rectum (Stage IVA) or peritoneal metastasis (M1).
  • Prior receipt of immunotherapy agents (including anti-PD-1, anti-PD-L1, anti-CTLA-4, etc.).
  • Prior radical surgery, radiotherapy, or systemic therapy (including investigational agents) for cervical cancer. Note: Conisation of the cervix is permitted.
  • Administration of any investigational drug within 4 weeks before the initiation of immunotherapy.
Show all 18Show fewer
  • Confirmed immunodeficiency or receipt of chronic systemic corticosteroid therapy (prednisone equivalent dose >10 mg/day) or other immunosuppressive therapy within 7 days prior to immunotherapy.
  • History of grade ≥3 severe hypersensitivity reactions to immunotherapeutic agents.
  • Active autoimmune disease requiring systemic therapy within the past 2 years (replacement therapies such as thyroxine, insulin and physiological glucocorticoids are excluded).
  • Prior history of non-infectious pneumonitis/interstitial lung disease requiring steroid treatment, or current active pneumonitis/interstitial lung disease.
  • Active infection requiring systemic treatment.
  • History of active hepatitis B (HBsAg positive) or active hepatitis C (detectable HCV RNA).
  • Any disease, treatment, laboratory abnormality or other condition that, in the investigator's judgement, may confound study results, hinder full study participation or pose additional risks to the subject.
  • Known psychiatric illness or substance abuse that may impair subject compliance; pregnant or breastfeeding females, or those planning conception/pregnancy during the study period (from screening to 120 days after the last study treatment).
  • Previous allogeneic tissue or solid organ transplantation.
  • History of HIV infection.
  • Metallic implants within the radiation field path that may compromise the accuracy of radiotherapy dose calculation.
  • Subject requests withdrawal from the study.

Trial locations and contacts

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

Zhuomin Yin, MD contact

yinzm@zjcc.org.cn

China1 site, 1 recruiting
  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    Zhuomin Yin, MD, yinzm@zjcc.org.cn

    Recruiting

Other trials in China

About this study

Official title: A Prospective Clinical Study of Immunotherapy Combined With Carbon Ion Radiotherapy for Locally Advanced Cervical Cancer

This study explores the therapeutic effect of carbon ion radiotherapy plus immunotherapy and chemotherapy for locally advanced cervical cancer.

Read the detailed description

The primary objective of this study is to explore whether carbon ion radiotherapy combined with immunotherapy and chemotherapy can improve the 2-year progression-free survival (PFS) of patients with locally advanced cervical cancer (Stage IIB-IVA). The secondary objectives are to investigate whether this regimen can improve the 2-year overall survival (OS) of patients with locally advanced cervical cancer, and to evaluate the adverse events associated with carbon ion radiotherapy combined with immunotherapy and chemotherapy based on RTOG and CTCAE criteria.

Being tested
Carbon ion external beam radiotherapy plus 3 courses of three-dimensional brachytherapy.
Keywords
Carbon Ion Radiotherapy, Immunotherapy, Chemotherapy, Survival Outcome, Uterine Cervical Neoplasms
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.

  • Carbon ion external beam radiotherapy plus 3 courses of three-dimensional brachytherapy.Radiation

    Also called Immunotherapy: Anti-PD-1 therapy, Chemotherapy

    Immunotherapy: Anti-PD-1 therapy administered once every 3 weeks starting at radiotherapy initiation, with a total maintenance duration of 2 years. Chemotherapy: Weekly concurrent single-agent cisplatin (dose: 40 mg/m² per week) or carboplatin (target AUC = 2) is given simultaneously with carbon ion external beam radiotherapy for a total of 4 cycles.

Study groups in NCT07702838
Study groupRoleWhat they receive
Immunotherapy Combined with Carbon Ion Radiotherapy and Concurrent Chemotherapy for Locally AdvancedExperimentalImmunotherapy: Anti-PD-1 therapy administered once every 3 weeks starting at radiotherapy initiation, with a total maintenance duration of 2 years. Chemotherapy: Weekly concurrent single-agent cisplatin (dose: 40 mg/m² per week) or carboplatin (target AUC = 2) given simultaneously with carbon ion external beam radiotherapy, for a total of 4 cycles. Radiotherapy: Carbon ion external beam radiotherapy plus 3 courses of three-dimensional intracavitary brachytherapy.
Receives: Radiation: Carbon ion external beam radiotherapy plus 3 courses of three-dimensional brachytherapy.

What is being measured

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

  1. Progression-free survival (PFS)

    This endpoint is determined based on investigators' assessments per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). If disease progression cannot be confirmed by imaging according to RECIST 1.1, progressive disease (PD) histopathologically verified following carbon ion radiotherapy combined with three-dimensional brachytherapy, concurrent chemotherapy and immunotherapy shall serve as the criterion for progression determination.

    Measured: At 2 years after the start of trial treatment

Secondary outcomes (2)
  1. Overall survival (OS)

    To evaluate the 2-year overall survival rate of patients treated with carbon ion radiotherapy plus three-dimensional intracavitary brachytherapy combined with concurrent chemotherapy and immunotherapy. Death from any cause is defined as the endpoint event. Subjects who remain alive or are lost to follow-up at the data cut-off date will be treated as censored data.

    Measured: At 2 years after the start of trial treatment

  2. Acute and late toxicities

    To evaluate acute and late toxicities of carbon ion radiotherapy plus three-dimensional intracavitary brachytherapy combined with concurrent chemotherapy and immunotherapy, graded per RTOG and CTCAE criteria.

    Measured: Acute toxicities: AEs within 90 days of carbon ion radiotherapy start, graded per CTCAE & RTOG acute radiation morbidity criteria. Late toxicities: Radiation-associated tissue injuries new or worsening >90 days after the star radiotherapy initiation.

Timeline

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

  1. First posted14 Jul 2026
  2. Study startJul 2026 (estimated)
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2030 (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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective single-arm clinical study
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07702838
Sponsor's protocol ID
IRB-2026-877(IIT)
Status last verified
Jul 2026
First submitted
29 Jun 2026
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared publicly due to limitations of institutional data repository, privacy protection of cervical cancer patients, and lack of dedicated funding for data curation and management.

Publications

  • Azzam AY, Ghozy S, Kallmes KM, Adusumilli G, Heit JJ, Hassan AE, Kadirvel R, Kallmes DF. Aspiration thrombectomy versus stent retriever thrombectomy alone for acute ischemic stroke: evaluating the overlapping meta-analyses. J Neurointerv Surg. 2023 Jan;15(1):34-38. doi: 10.1136/neurintsurg-2022-018849. Epub 2022 May 18.

    PubMed 35584912
  • Wakatsuki M, Kato S, Kiyohara H, Ohno T, Karasawa K, Tamaki T, Ando K, Tsujii H, Nakano T, Kamada T, Shozu M; Working Group of the Gynecological Tumor. Clinical trial of prophylactic extended-field carbon-ion radiotherapy for locally advanced uterine cervical cancer (protocol 0508). PLoS One. 2015 May 20;10(5):e0127587. doi: 10.1371/journal.pone.0127587. eCollection 2015.

    PubMed 25993047
  • Wakatsuki M, Kato S, Ohno T, Karasawa K, Ando K, Kiyohara H, Tsujii H, Nakano T, Kamada T, Shozu M; Working Group of the Gynecological Tumor. Dose-escalation study of carbon ion radiotherapy for locally advanced squamous cell carcinoma of the uterine cervix (9902). Gynecol Oncol. 2014 Jan;132(1):87-92. doi: 10.1016/j.ygyno.2013.10.021. Epub 2013 Oct 29.

    PubMed 24183732
  • Jahangir Z, Bakillah A, Iqbal J. Regulation of Sphingolipid Metabolism by MicroRNAs: A Potential Approach to Alleviate Atherosclerosis. Diseases. 2018 Sep 17;6(3):82. doi: 10.3390/diseases6030082.

    PubMed 30227643
  • Elmanfi S, Ma X, Sintim HO, Kononen E, Syrjanen S, Gursoy UK. Quorum-sensing molecule dihydroxy-2,3-pentanedione and its analogs as regulators of epithelial integrity. J Periodontal Res. 2018 Jun;53(3):414-421. doi: 10.1111/jre.12528. Epub 2018 Jan 17.

    PubMed 29344966
  • Laserson U, Vigneault F, Gadala-Maria D, Yaari G, Uduman M, Vander Heiden JA, Kelton W, Taek Jung S, Liu Y, Laserson J, Chari R, Lee JH, Bachelet I, Hickey B, Lieberman-Aiden E, Hanczaruk B, Simen BB, Egholm M, Koller D, Georgiou G, Kleinstein SH, Church GM. High-resolution antibody dynamics of vaccine-induced immune responses. Proc Natl Acad Sci U S A. 2014 Apr 1;111(13):4928-33. doi: 10.1073/pnas.1323862111. Epub 2014 Mar 17.

    PubMed 24639495
  • Zhang G, Zhang Z, Pei Y, Hu W, Xue Y, Ning R, Guo X, Sun Y, Zhang Q. Biological and clinical significance of radiomics features obtained from magnetic resonance imaging preceding pre-carbon ion radiotherapy in prostate cancer based on radiometabolomics. Front Endocrinol (Lausanne). 2023 Oct 20;14:1272806. doi: 10.3389/fendo.2023.1272806. eCollection 2023.

    PubMed 38027108
  • Buizza G, Paganelli C, D'Ippolito E, Fontana G, Molinelli S, Preda L, Riva G, Iannalfi A, Valvo F, Orlandi E, Baroni G. Radiomics and Dosiomics for Predicting Local Control after Carbon-Ion Radiotherapy in Skull-Base Chordoma. Cancers (Basel). 2021 Jan 18;13(2):339. doi: 10.3390/cancers13020339.

    PubMed 33477723
  • Ma L, Li Y, Sakamoto Y, Xie L, Suzuki S, Yoshida Y, Sui L, Guo G, Wen J, Ren W, Kakimi K, Osada K, Takahashi A, Shimokawa T. Optimal radiation dose to induce an abscopal effect by combining carbon-ion radiotherapy and anti-CTLA4 antibody. Neoplasia. 2025 Feb;60:101099. doi: 10.1016/j.neo.2024.101099. Epub 2024 Dec 13.

    PubMed 39674115
  • Shiba S, Okonogi N, Kato S, Wakatsuki M, Kobayashi D, Kiyohara H, Ohno T, Karasawa K, Nakano T, Kamada T. Clinical Impact of Re-irradiation with Carbon-ion Radiotherapy for Lymph Node Recurrence of Gynecological Cancers. Anticancer Res. 2017 Oct;37(10):5577-5583. doi: 10.21873/anticanres.11991.

    PubMed 28982873
  • Okonogi N, Ando K, Murata K, Wakatsuki M, Noda SE, Irie D, Tsuji H, Shozu M, Ohno T. Multi-Institutional Retrospective Analysis of Carbon-Ion Radiotherapy for Patients with Locally Advanced Adenocarcinoma of the Uterine Cervix. Cancers (Basel). 2021 May 31;13(11):2713. doi: 10.3390/cancers13112713.

    PubMed 34072676
  • Wang X, Chen X, Li G, Han X, Gao T, Liu W, Tang X. Application of Carbon Ion and Its Sensitizing Agent in Cancer Therapy: A Systematic Review. Front Oncol. 2021 Jul 5;11:708724. doi: 10.3389/fonc.2021.708724. eCollection 2021.

    PubMed 34290989
  • Tinganelli W, Durante M. Carbon Ion Radiobiology. Cancers (Basel). 2020 Oct 17;12(10):3022. doi: 10.3390/cancers12103022.

    PubMed 33080914
  • Reinhardt JM, Christensen GE, Hoffman EA, Ding K, Cao K. Registration-derived estimates of local lung expansion as surrogates for regional ventilation. Inf Process Med Imaging. 2007;20:763-74. doi: 10.1007/978-3-540-73273-0_63.

    PubMed 17633746
  • Paskett ED. Breast cancer-related lymphedema: attention to a significant problem resulting from cancer diagnosis. J Clin Oncol. 2008 Dec 10;26(35):5666-7. doi: 10.1200/JCO.2008.19.0850. Epub 2008 Nov 10. No abstract available.

    PubMed 19001317

Questions about this trial

What is this clinical trial studying?

A study testing Carbon ion external beam radiotherapy plus 3 courses of three-dimensional brachytherapy. in people with Uterine Cervical Neoplasms, run by Zhejiang 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 14 inclusion and 18 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 14 Jul 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.

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 Zhuomin Yin, MD (yinzm@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: At 2 years after the start of trial treatment). 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 NCT07702838, which also lists 24 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 14 Jul 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in