Intratumoral Gemcitabine, Paclitaxel, Carboplatine and Intravenous Nivolumab for Locally Recurrence of Head and Neck Cancers
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- local response rate according to RECIST criteria
研究概览
简要总结
Patients with locally recurrent squamous-cell carcinoma of the head and neck (SCCHN) after Chemotherapy and immunotherapy have a very poor prognosis and limited therapeutic options.
Intratumoral chemotherapy (ITC) with cisplatin and epinephrine in order to increase the local cisplatin retention lead to a 50 % response rate in several studies but was given up due to the poor local tolerance with frequent necrosis of the peritumoral tissues. Gemcitabine, carboplatin and paclitaxel (GCP) are used in advanced SCCHN. These chemotherapies seem to be interesting options for intratumoral infusion: their different effect could lead to avoid chemotherapy resistance with a good tolerance profile, without tissue necrosis profile. The other major option for recurrent SCCHN is immunotherapy by Nivolumab, an anti PD-1 with a 13% mediane response rate. Nevertheless, the failure of this treatment stay unclear, but immunosuppressive action of the tumour is suspected. The presence of tumoral antigen could lead to better response to immunotherapy; association of chemotherapy and immunotherapy seems a promosing association to avoid treatment resistance as cytotoxic release tumoral antigen; it could also be associated to an abscopal effect.
The aim of the study is to evaluate the efficacy of ITC using GCP in LOCAL recurrent SCCHN treated by nivolumab.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •WHO status : 0, 1 or
- •Age > 18ans
- •Locally recurrence of a histologically-proven SCCHN after failure of conventional treatments (surgery, radiotherapy, chemotherapy with platinum compounds, cetuximab)
- •Nivolumab treatment in second line encouring according to AMM but with insufficient efficacy
- •Possible location of the tumour by clinical examination, CT-scan
- •Metastases are admitted if there is no vital prognoses threaten and if a clinical benefit is expected by treating local recurrence.
- •Neutrophils > 1000/mm
- •Platelets > 100 000/mm
- •Blood créatinine < 15 mg/L. Blood bilirubine < 30 mg/L
- •Prothrombin rate > 70 %.
- •Social insurance
- •Informed consent
排除标准
- •WHO status : 0, 1 or
- •Age > 18ans
- •Locally recurrence of a histologically-proven SCCHN after failure of conventional treatments (surgery, radiotherapy, chemotherapy with platinum compounds, cetuximab)
- •Nivolumab treatment in second line encouring according to AMM but with insufficient efficacy
- •Possible location of the tumour by clinical examination, CT-scan
- •Metastases are admitted if there is no vital prognoses threaten and if a clinical benefit is expected by treating local recurrence.
- •Neutrophils > 1000/mm
- •Platelets > 100 000/mm
- •Blood créatinine < 15 mg/L. Blood bilirubine < 30 mg/L
- •Prothrombin rate > 70 %.
- •Social insurance
- •Informed consent
研究组 & 干预措施
Intratumoral chemotherapy
干预措施: GCP intratumoral catheter (Drug)
结局指标
主要结局
local response rate according to RECIST criteria
时间窗: 3 years
RECIST is a standard way to measure the response of a tumor to treatment. The criteria to determine whether a tumor disappears, shrinks, are complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD). Evaluation of target lesions * Complete Response (CR): Disappearance of all target lesions * Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD * Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions * Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Evaluation of non-target lesions * Complete Response (CR): Disappearance of all non-target lesions and no
次要结局
未报告次要终点