Camrelizumab Plus Stereotactic Body Radiotherapy vs Camrelizumab Alone For Oligometastatic Nasopharyngeal Carcinoma: A Multicenter Randomized Clinical Phase 3 Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Median progression-free survival (PFS)
研究概览
简要总结
We intend to compare the efficacy and safety of immunotherapy plus stereotactic body radiotherapy at oligometastatic lesions and immunotherapy alone among patients with oligometastatic nasopharyngeal carcinoma whose primary lesion has been well controlled after radical local-regional treatment through this multicenter randomized phase 3 trial.
详细描述
We intend to apply camrelizumab plus stereotactic body radiotherapy at oligometastatic lesions to patients with oligometastatic nasopharyngeal carcinoma whose primary lesion has been well controlled after radical treatment through this multicenter randomized phase 3 trial to investigate whether stereotactic body radiotherapy at oligometastatic lesions on the basis of immunotherapy can achieve clinical cure among a part of patients with distant metastasis and improve their overall survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female; 18-70 years of age.
- •Primary lesion and regional lymph nodes completed radical radiotherapy 3 months before stereotactic body radiotherapy and diseases well controlled.
- •Underwent at least first-line systemic chemotherapy, regardless of regimen and curative effect.
- •Imageological evidence for oligometastatic lesions (metastatic tissue biopsy preferred but not necessary). The number of total metastatic lesions no more than 5 and the number of metastatic lesions within a single organ no more than
- •ECOG performance status of 0 or
- •Stereotactic body radiotherapy applicable for all metastatic lesions according to MDT.
- •If metastatic lesions have received local treatment (surgery, radiofrequency ablation, radiotherapy etc.):
- •Eligible if treated lesion is well controlled according to imageological examinations, and the lesion does not need stereotactic body radiotherapy.
- •If treated lesion is not controlled according to imageological examinations:
- •Eligible if the treatment is surgery and that stereotactic body radiotherapy is applicable for the treated lesion.
- •Ineligible if the treatment is radiofrequency ablation or radiotherapy.
- •Maximum diameter of brain metastatic lesion no more than 3cm.
- •Maximum diameter of metastatic lesion (brain excluded) no more than 5cm.
- •Maximum diameter of bone metastatic lesion no more than 6cm if attending doctor decides it is safe to apply the treatment.
- •Life expectancy more than 12 weeks.
排除标准
- •Immunotherapy (PD-1/PD-L1 or CTLA-4 monoclonal antibody) failure.
- •CHD no less than grade 2, arrhythmia (QTc interval over 450ms for male and 470ms for female) or cardiac insufficiency.
- •History of severe hypersensitivity to any ingredient of PD-1/PD-L1 or other monoclonal antibody.
- •chemotherapy (cytotoxic or molecular targeted) within 4 weeks before stereotactic body radiotherapy.
- •Imageological evidence for spinal cord compression, or tumor less than 3mm away from spinal cord.
- •Patient with brain metastasis who needs decompression surgery.
- •Other malignancy or malignant hydrothorax.
- •Concurrent known or suspicious autoimmune disease, including dementia and epilepsy.
- •Use of large dose corticosteroids within 4 weeks before study drug administration.
- •Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids.
- •Active tuberculosis (TB), anti-TB treatment is ongoing or within 1 year prior to screening
- •Subjects with any active autoimmune disease or history of autoimmune disease, or history of syndrome that requires systemic steroids or immunosuppressive medications, including but not limited to the following: rheumatoid arthritis, pneumonitis, colitis (inflammatory bowel disease), hepatitis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy.
- •Has a known history of human immunodeficiency virus (HIV), has hepatitis B surface antigen (HBsAg) positive with hepatitis B virus (HBV) DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive.
- •Received any anti-infective vaccine (e.g. influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment.
- •Pregnancy or lactation.
- •Other ineligible patients according to attending doctor.
研究组 & 干预措施
Camrelizumab Plus Stereotactic Body Radiotherapy
Patients receive camrelizumab(200mg, iv drip for over 60min) every 2 weeks from 2 weeks before radiotherapy, and then receive stereotactic body radiotherapy until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision or the upper limit of treatment duration of 1 year.
干预措施: camrelizumab (Drug)
Camrelizumab Plus Stereotactic Body Radiotherapy
Patients receive camrelizumab(200mg, iv drip for over 60min) every 2 weeks from 2 weeks before radiotherapy, and then receive stereotactic body radiotherapy until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision or the upper limit of treatment duration of 1 year.
干预措施: stereotactic body radiotherapy (Radiation)
Camrelizumab
Patients receive camrelizumab(200mg, iv drip for over 60min) every 2 weeks until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision or the upper limit of treatment duration of 1 year.
干预措施: camrelizumab (Drug)
结局指标
主要结局
Median progression-free survival (PFS)
时间窗: 2 years
Progression-free survival is calculated from the date of randomization to the date of death of any cause or the first progress at any site, censored on the last date of tumor evaluation if no progress has happened.
次要结局
- Disease control rate (DCR)(2 years)
- Clinical benefit rate (CBR)(2 years)
- Median overall survival (OS)(2 years)
- Adverse events(2 year)
- Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)(2 years.)
- Objective response rate (ORR)(2 years)
- Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)(2 years)
研究者
Ming-Yuan Chen
professor & chief physician
Sun Yat-sen University