Study of Tumor Infiltrating Lymphocytes Following Concurrent Chemoradiotherapy in the Treatment of Patients With Cervical Carcinoma
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Toxicity Evaluation
研究概览
简要总结
A Phase I trial to evaluate the feasibility, toxicity and effectiveness of cisplatin concurrent chemoradiotherapy plus TIL in treating patients with FIGO stage IIIA to IVA cervical carcinoma.
详细描述
Concurrent chemoradiotherapy (CCRT) was the standard treatment for locoregionally advanced cervical cancer, while the incidence of treatment failure is still high. Adjuvant chemotherapy or inducing chemotherapy addition to CCRT did not significantly improve patient survival compared to CCRT alone. Hence, there is a need for novel therapies to improve survival for these patients.
Accumulating evidence shows that tumor-infiltrating lymphocytes (TILs) selected for tumor recognition and greatly expanded in vitro are effective for treating cervical cancer patients.
This is a phase I trial to evaluate the feasibility, toxicity and effectiveness of cisplatin concurrent chemoradiotherapy plus TIL in treating patients with FIGO stage IIIA to IVA cervical carcinoma.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically proven squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervical uteri
- •Patients with stage IIIA-IVA cervical cancer according to the International Federation of Gynecology and Obstetrics (FIGO)
- •Patients who were ≥ 18 and ≤ 70 years old
- •Patients with an ECOG performance status of 0, 1, or 2
- •Adequate hematological, renal, and hepatic functions defined as:
- •granulocytes ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, total bilirubin, ALT and AST ≤ 1.5 x upper normal limit, creatinine ≤ upper normal limit
- •Patients provided written, voluntary informed consent
- •Patients who were accessible to follow up and management in the treatment center
排除标准
- •Patients with past or current history of malignancy other than the entry diagnosis except for a "cured" malignancy more than five years prior to enrollment
- •Patients who received previous chemotherapy or radiotherapy
- •Patients with active angina or documented myocardial infarction within the 6 months preceding registration and patients with a history of significant ventricular arrhythmia requiring medication or congestive heart failure, as well as a history of 2nd or 3rd degree heart blocks
- •Patients with an active infection or other serious underlying medical conditions that would impair the ability of the patient to receive the planned treatment, including prior allergic reactions to drugs containing platinum
- •Patients with dementia or altered mental status that would prohibit the understanding and providing of informed consent
- •Patients with inadequate caloric and/or fluid intake
研究组 & 干预措施
CCRT+TIL
Cisplatin based concurrent chemoradiotherapy(CCRT) combined with tumor-infiltrating lymphocyte (TIL)
干预措施: CCRT+TIL (Drug)
结局指标
主要结局
Toxicity Evaluation
时间窗: From chemo-radiotherapy start until Day30 after TIL infusion
Patients will be monitored for clinical toxicity by by the National Cancer Institute Common Terminology Criteria for Adverse Events.
Feasibility of CCRT in combination with TIL successful infusion
时间窗: 30 days after start of TIL-ACT infusion
Number of patients receiving a complete TIL infusion
次要结局
- Objective Response Rate (ORR)(1, 3, 6, 9, 12 months)
- Disease control rate (DCR)(1, 3, 6, 9, 12 months)
- Disease control time (DCT)(1, 3, 6, 9, 12 months)
- Immunological correlates to tumor response(1, 3, 6, 9, 12 months)
研究者
Jihong Liu
Professor
Sun Yat-sen University