NCT07164690尚未招募2 期
Low-Dose Radiotherapy in Patients With Advanced Esophageal Squamous Cell Carcinoma Resistant to First-Line Chemotherapy Combined With Immunotherapy: a Phase II, Single-arm Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 32
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
Brief Summary
The goal of this single-arm Phase II clinical trial is to learn whether low-dose radiotherapy (LDRT) can restore sensitivity to immunotherapy and prolong disease control in adults with advanced esophageal squamous cell carcinoma who have progressed after first-line chemotherapy combined with PD-1/PD-L1 inhibitors. The main questions it aims to answer are:
- Can LDRT followed by continued immunotherapy increase progression-free survival compared with historical data?
- What is the objective response rate after adding LDRT to ongoing immunotherapy?
- Is LDRT combined with immunotherapy safe in this heavily pre-treated population?
Participants will:
- Receive a single fraction of 2 Gy to every visible metastatic lesion within one week
- Continue their prior PD-1/PD-L1 inhibitor (e.g., camrelizumab, pembrolizumab) after LDRT is completed
- Undergo tumor imaging every 6 weeks for up to one year to monitor response
- Provide optional blood and tissue samples for exploratory biomarker studies
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
- •Age≥18 years old;
- •ECOG score 0-1;
- •Histologically or cytologically confirmed esophageal squamous cell carcinoma that is locally advanced (unresectable) or metastatic (AJCC/TNM 8th edition).
- •Progression during or after one prior systemic first-line regimen that contained both a platinum-based chemotherapy and a PD-1/PD-L1 inhibitor (progression must be documented radiologically or clinically). Patients who received neoadjuvant/adjuvant therapy containing a PD-1/PD-L1 inhibitor are considered first-line failures if progression/recurrence occurs during or within 6 months after completion of that therapy.
- •At least one measurable lesion per RECIST 1.1 within 4 weeks before enrollment. NOTE: a previously irradiated lesion cannot serve as a target lesion unless clear progression after radiotherapy is documented.
- •Life expectancy ≥ 3 months.
- •Adequate organ function within 1 week before enrollment:
- •Hematologic: Hb ≥ 80 g/L; WBC ≥ 3.0 × 10⁹/L or ANC ≥ 1.5 × 10⁹/L; platelets ≥ 100 × 10⁹/L.
- •Hepatic: total bilirubin ≤ 1.5 × ULN (direct bilirubin ≤ ULN if total > 1.5 × ULN); ALT/AST ≤ 2.5 × ULN.
- •Renal: serum creatinine < 1.5 × ULN or creatinine clearance ≥ 50 mL/min; BUN ≤ 200 mg/L; albumin ≥ 30 g/L.
- •Ability to understand and provide written informed consent.
排除标准
- •Active autoimmune disease (e.g., inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, vasculitis).
- •Symptomatic interstitial lung disease or active infectious/non-infectious pneumonitis.
- •Tumor invasion into adjacent organs (aorta or trachea) with high risk of bleeding or fistula; prior esophageal stent placement.
- •Other malignancies within the past 2 years (except adequately treated basal-cell carcinoma, cervical carcinoma in situ, etc.).
- •Active infection, heart failure, myocardial infarction within 6 months, unstable angina, or uncontrolled arrhythmia.
- •Any condition that, in the investigator's opinion, could interfere with study results or increase patient risk.
- •Mixed small-cell histology.
- •Pregnant or breastfeeding women.
- •Congenital or acquired immunodeficiency, HIV infection, prior organ or allogeneic stem-cell transplantation.
- •Active HBV, HCV, or tuberculosis infection.
- •Prior tumor vaccine or any live vaccine within 4 weeks (inactivated influenza vaccine is allowed).
- •Concurrent use of other immunosuppressive agents, chemotherapy, investigational drugs, or chronic corticosteroids.
- •Psychiatric illness, substance abuse, or social issues that could compromise compliance.
- •Prior intolerance, hypersensitivity, or contraindication to PD-1/PD-L1 inhibitors or chemotherapy components.
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: 1 year
次要结局
- Overall Survival (OS)(1 year)
- Objective Response Rate (ORR)(1 year)
- Treatment-related adverse event (TRAE)(1 year)
研究者
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