Whole-target Consolidation Therapy After Standard Chemotherapy for Initial Diagnosed Distant Metastatic Nasopharyngeal Carcinoma Under Full-course Immunotherapy: An Open-Label, Single Center, Nonrandomized, Phase 2 Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Median progression-free survival (PFS)
研究概览
简要总结
In this exploratory clinical trial, patients with newly diagnosed distant metastatic nasopharyngeal carcinoma were treated with gemcitabine+ cisplatin+PD-1 inhibitor regimen followed by whole-target radiotherapy (IMRT for local regional lesion, SBRT for distant metastasis) and PD-1 inhibitor long-term maintenance regimen. To investigate the efficacy and safety of "whole target" radiotherapy combined with immuno-maintenance therapy.
详细描述
This exploratory clinical trial will evaluate tumor control rate, survival, and safety of newly diagnosed distant metastatic nasopharyngeal carcinoma by further adding local regional IMRT, distant metastatic SBRT and immuno-maintenance therapy to the standard regimen of gemcitabine+ cisplatin+ PD-1 inhibitor (historical data). To explore whether the "full target" model can be a better comprehensive therapy for the initial diagnosed distant metastatic nasopharyngeal carcinoma in the era of immunotherapy.
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
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.
- •Had histopathologically confirmed nonkeratinizing metastatic NPC that was diagnosed as stage IVb NPC (AJCC, 8th; the metastatic tissue biopsy is preferred, not necessary).
- •Patients who had not received anti-tumor therapy for nasopharyngeal cancer before this clinical trial.
- •Patients evaluated to have a partial response (PR) or stable disease (SD) by head and neck MRI and PET/CT after 3 months of locoregional radiotherapy, and the metastatic lesions were assessed as oligometastatic lesions (the number of total metastatic lesions no more than 5 and the number of metastatic lesions within a single organ no more than 3).
- •Stereotactic body radiotherapy applicable for all metastatic lesions according to MDT.
- •ECOG performance status of 0 or
- •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 6 months.
排除标准
- •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.
- •CHD no less than grade 2, arrhythmia (QTc interval over 450ms for male and 470ms for female) or cardiac insufficiency.
- •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 were treated with gemcitabine, cisplatin and camrelizumab for 6 cycles, followed by whole-target radiotherapy (IMRT for locoregional lesion and SBRT for oligometastatic lesions) and camrelizumab maintenance therapy.
干预措施: Camrelizumab, gemcitabin, cisplatin (Drug)
Camrelizumab Plus Stereotactic Body Radiotherapy
Patients were treated with gemcitabine, cisplatin and camrelizumab for 6 cycles, followed by whole-target radiotherapy (IMRT for locoregional lesion and SBRT for oligometastatic lesions) and camrelizumab maintenance therapy.
干预措施: Stereotactic Body Radiotherapy, Intensity modulated-radiotherapy (Radiation)
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
- Objective response rate (ORR)(2 years)
- Median overall survival (OS)(2 years)
- Duration of response (DoR)(2 years)
- Adverse events(2 years)
- Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)(2 years)
- Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)(2 years)
- Disease control rate (DCR)(2 years)
研究者
Ming-Yuan Chen
professor & chief physician
Sun Yat-sen University