A Prospective Clinical Study of Immunotherapy Combined With Carbon Ion Radiotherapy for Locally Advanced Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This study explores the therapeutic effect of carbon ion radiotherapy plus immunotherapy and chemotherapy for locally advanced cervical cancer.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open-label study, no masking performed
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
- •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
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
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.
干预措施: Carbon ion external beam radiotherapy plus 3 courses of three-dimensional brachytherapy. (Radiation)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 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.
次要结局
- Overall survival (OS)(At 2 years after the start of trial treatment)
- Acute and late toxicities(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.)
研究者
Yin ZhuoMin
Professor
Zhejiang Cancer Hospital