Health TrialsbyHealthPanel

Immunotherapy Combined With Carbon Ion Radiotherapy for Locally Advanced Cervical Cancer

ConditionUterine Cervical Neoplasms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorZhejiang Cancer Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.).

Trial design

Design model

Single group

Treatments tested in this trial

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

    Radiation

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Immunotherapy Combined with Carbon Ion Radiotherapy and Concurrent Chemotherapy for Locally AdvancedExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
At 2 years after the start of trial treatment

Secondary outcomes

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.

Time frame
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.

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov
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