Immunotherapy Combined With Carbon Ion Radiotherapy for Locally Advanced Cervical Cancer

July 12, 2026 updated by: Yin ZhuoMin, Zhejiang Cancer Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Female patients aged ≥ 18 years at the time of signing the informed consent form.
  2. Histopathologically confirmed diagnosis of cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma).
  3. Stage IIB-IVA disease per the 2018 FIGO staging system.
  4. Presence of measurable lesions as defined by RECIST version 1.1.
  5. Patients reviewed by the carbon ion radiotherapy multidisciplinary team (MDT) with an indication for carbon ion radiotherapy.
  6. Patients voluntarily receiving carbon ion radiotherapy at Zhejiang Cancer Hospital and bearing all relevant treatment expenses.
  7. Complete clinical and imaging data available.
  8. Patients willing to participate in the trial and complete questionnaire surveys.
  9. Patients willing to participate in the trial and provide biospecimens, including cervical tissue, various body fluid specimens and tissue samples.
  10. Patients willing to attend regular standardised outpatient follow-up visits at our hospital.
  11. Eastern Cooperative 11. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2.
  12. No prior history of surgery, radiotherapy or chemotherapy for cervical cancer.
  13. 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).
  14. Estimated overall survival ≥ 6 months.

Exclusion Criteria:

  1. Presence of severe concomitant complications (e.g., uncontrolled cardiovascular disease, hypertension, diabetes mellitus, refractory infection, active peptic ulcer, uncontrolled psychiatric disorders, etc.)
  2. Concurrent active second primary malignancy.
  3. Tumour invasion of the rectum (Stage IVA) or peritoneal metastasis (M1).
  4. Prior receipt of immunotherapy agents (including anti-PD-1, anti-PD-L1, anti-CTLA-4, etc.).
  5. Prior radical surgery, radiotherapy, or systemic therapy (including investigational agents) for cervical cancer. Note: Conisation of the cervix is permitted.
  6. Administration of any investigational drug within 4 weeks before the initiation of immunotherapy.
  7. 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.
  8. History of grade ≥3 severe hypersensitivity reactions to immunotherapeutic agents.
  9. Active autoimmune disease requiring systemic therapy within the past 2 years (replacement therapies such as thyroxine, insulin and physiological glucocorticoids are excluded).
  10. Prior history of non-infectious pneumonitis/interstitial lung disease requiring steroid treatment, or current active pneumonitis/interstitial lung disease.
  11. Active infection requiring systemic treatment.
  12. History of active hepatitis B (HBsAg positive) or active hepatitis C (detectable HCV RNA).
  13. 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.
  14. 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).
  15. Previous allogeneic tissue or solid organ transplantation.
  16. History of HIV infection.
  17. Metallic implants within the radiation field path that may compromise the accuracy of radiotherapy dose calculation.
  18. Subject requests withdrawal from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immunotherapy Combined with Carbon Ion Radiotherapy and Concurrent Chemotherapy for Locally Advanced

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) 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.
Radiation: Carbon ion external beam radiotherapy plus 3 courses of three-dimensional brachytherapy.
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.
Other Names:
  • Chemotherapy
  • Immunotherapy: Anti-PD-1 therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: At 2 years after the start of trial treatment
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.
At 2 years after the start of trial treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: At 2 years after the start of trial treatment
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.
At 2 years after the start of trial treatment
Acute and late toxicities
Time Frame: 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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Cancer Hospital

Investigators

  • Study Chair: Hanmei Lou, MD, Zhejiang Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

June 29, 2026

First Submitted That Met QC Criteria

July 12, 2026

First Posted (Actual)

July 14, 2026

Study Record Updates

Last Update Posted (Actual)

July 14, 2026

Last Update Submitted That Met QC Criteria

July 12, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-2026-877（IIT）

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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