A Phase I/II Multicenter Study Evaluating the Efficacy and Safety of Induction Immunochemotherapy Followed by Concurrent Immuno-Chemoradiotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Cancer(SCR-ESCC-02)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
SCR-ESCC-02 is a multicenter, phase I/II clinical study to investigate the safety and efficacy of induction immunochemotherapy followed by concurrent chemoradiotherapy with anti-PD-1 therapy in patients diagnosed with locally advanced, unresectable esophageal cancer.
详细描述
Immunotherapy has shown promising results in advanced esophageal cancer, but its optimal integration into the management of unresectable locally advanced disease remains uncertain. The significant tumor regression and reduced tumor residual achieved through immunochemotherapy offer an opportunity to enhance the effectiveness of subsequent radiotherapy. This phase I/II clinical study aims to investigate the efficacy and safety of induction immunochemotherapy followed by concurrent chemoradiotherapy with anti-PD-1 for patients with unresectable locally advanced esophageal cancer. The study's co-primary endpoints are progression-free survival (PFS) and treatment completion rate.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Clinical stage meeting the criteria of T1N+M0 or T2-4aN0-3M0 based on the 8th UICC-TNM classification.
- •Ineligibility for surgical resections due to patients' unwillingness for surgery, technically unresectable disease, or being medically unfit for surgery.
- •No prior anti-tumor treatment, including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy.
- •Adequate hematological, pulmonary, cardiac, hepatic, renal, and thyroid function.
- •Willingness to use contraception with an adequate method throughout the study.
- •Documented informed consent.
排除标准
- •History of malignant disease within the 5 years preceding enrollment or presence of other malignant tumors or non-squamous cell carcinoma components.
- •High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation as determined by the investigators.
- •Weight loss exceeding 20% within the 90 days prior to the first day of drug administration.
- •Presence of long-standing unhealed wounds or fractures or undergoing major surgical resections within 60 days preceding the first day of drug administration.
- •Presence of any severe or uncontrolled coexisting diseases, including but not limited to:
- •Uncontrolled hypertension
- •History of interstitial lung disease or non-infectious pneumonia
- •Active hepatitis B or C, syphilis, or other active and uncontrolled infections
- •Cardiac insufficiency (NYHA≥2)
- •Renal dysfunction requiring dialysis
- •Active autoimmune disease
- •History of acquired or congenital immunodeficiency diseases
- •Occurrence of serious arterial/venous thrombotic events within 6 months prior to the first day of drug administration.
- •History of psychotropic substance abuse or inability to quit, or patients with psychotic disorders.
- •Allergy to study drugs.
- •Patients deemed unsuitable for participation due to severe comorbidities or other reasons determined by the investigators.
研究组 & 干预措施
IC+ICRT group
2 cycles of PD-1 inhibitor + nab-paclitaxel + cisplatin followed by concurrent PD-1 inhibitor + radiotherapy (45-50Gy/25fx) + nab-paclitaxel + cisplatin
干预措施: PD-1inhibitor (Drug)
IC+ICRT group
2 cycles of PD-1 inhibitor + nab-paclitaxel + cisplatin followed by concurrent PD-1 inhibitor + radiotherapy (45-50Gy/25fx) + nab-paclitaxel + cisplatin
干预措施: nab-paclitaxel + cisplatin (Drug)
IC+ICRT group
2 cycles of PD-1 inhibitor + nab-paclitaxel + cisplatin followed by concurrent PD-1 inhibitor + radiotherapy (45-50Gy/25fx) + nab-paclitaxel + cisplatin
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Progression-free survival
时间窗: Assessed up to 60 months
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first
Treatment completion rate
时间窗: 1 year
The Treatment Completion Rate is defined as the percentage of patients who successfully completed concurrent immuno-chemoradiotherapy.
次要结局
- Objective response rate(1 year)
- Overall survival(Assessed up to 60 months)
- Incidence of Adverse events (AE) or severe adverse events (SAE)(1 year)
研究者
Wen Yu
Vice Director of Radiation Oncology Department
Shanghai Chest Hospital