NCT04741490Unknown不适用
A Single-arm, Exploratory Clinical Study of Camrelizumab Combined With Radiotherapy for Adjuvant Treatment of Esophageal Squamous Cell Carcinoma After Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1-year disease-free survival rate (1-year DFS)
研究概览
简要总结
This is an investigator-initiated, single-arm, single-center, exploratory clinical study.The study population consisted of patients with R0 resection of esophageal squamous cell carcinoma who had not received radiation therapy.The purpose of this study was to evaluate the efficacy and safety of carrelizumab combined with radiotherapy in the adjuvant treatment of esophageal squamous cell carcinoma after surgery.About 20 subjects are planned to be enrolled in this study.Drug regimen: Patients with esophageal squamous cell carcinoma received radiotherapy combined with carrilizumab adjuvant therapy for 6 cycles 1-3 months after R0 resection.
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 18 - 75 year，male or female；
- •The clinical stages of esophageal squamous cell carcinoma diagnosed by pathology (including histology or cytology) were T1-4AN0M0 and T1-4AN +M0
- •Patients who underwent surgical resection and were assessed as R0.However, patients who have received previous radiotherapy should be excluded
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1；
- •Survival expectation ≥ 3 months;
- •The laboratory test value of the patient before medication should meet the following standards:
- •Routine blood：WBC≥3.0 × 109/L；ANC≥1.5 × 109/L；PLT≥90 × 109/L；HGB≥9.0 g/dL；
- •Liver function：TBIL≤1.5 × ULN，AST≤2.5 × ULN，ALT≤2.5 × ULN（Subjects with liver metastasis，AST≤5× ULN，ALT≤5 × ULN）；
- •Renal function：Cr≤1.5 × ULN or CrCl ≥50 mL/min；
- •Blood coagulation function：INR≤1.5，APTT≤1.5 ×ULN ；
- •Women of childbearing age must have a serum pregnancy study within 2 weeks prior to the first dose and the results are negative. Female subjects of childbearing age and partners who are women of childbearing age must be contraceptive during the study period and within 180 days after the last administration of the study drug;
排除标准
- •Known or suspected history of active autoimmune diseases, autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes)
- •Have a history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency disease, or history of organ transplantation and bone marrow transplantation；
- •Interstitial lung disease, drug-induced pneumonia, radiation pneumonitis requiring steroid therapy or active pneumonia with clinical symptoms or severe pulmonary dysfunction；
- •There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) heart failure of NYHA class 2 or higher (2) unstable angina (3) myocardial infarction within 24 weeks (4) clinical need for treatment or Interventional supraventricular or ventricular arrhythmia；
- •Have a tendency to hereditary bleeding or coagulopathy. Clinically significant bleeding symptoms or clear bleeding tendency within 3 months prior to enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood++ and above；
- •Has not fully recovered from toxicity and/or complications from any intervention prior to initiation of treatment (i.e., ≤ grade 1 or level required at baseline, excluding fatigue or hair loss);
- •Allergic reactions to test drugs for this application；
- •Pregnant or lactating women；
- •Those whom the investigator considered unsuitable for inclusion。
研究组 & 干预措施
treatment group
Experimental
The adjuvant treatment of radiotherapy combined with carrilizumab lasted for 6 cycles
干预措施: Camrelizumab (Drug)
treatment group
Experimental
The adjuvant treatment of radiotherapy combined with carrilizumab lasted for 6 cycles
干预措施: radiotherapy (Radiation)
结局指标
主要结局
1-year disease-free survival rate (1-year DFS)
时间窗: up to approximately 1 year
The percentage of subjects who were free of disease recurrence or death from the start of study enrolment to 12 months later.
次要结局
- Progression-Free Survival (PFS)(up to approximately 2 year)
- Disease-free survival (DFS)(up to approximately 2 year)
- Overall survival (OS)(up to approximately 3 year)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
1 期
Tirellizumab Combined With Chemotherapy Monotherapy for Non-small Cell Lung CancerNon-small Cell Lung CancerNCT05965102Second Affiliated Hospital of Guangzhou Medical University31
Enrolling By Invitation
2 期
the Prevention of Bone Marrow Suppression Caused by Chemotherapy in Advanced NSCLC With TrilaciclibNon-small Cell Lung CancerNCT06370416Henan Cancer Hospital41
招募中
不适用
Anrotinib Hydrochloride Combined With Adriamycin for Neoadjuvant Treatment of High-grade Soft Tissue SarcomaSoft Tissue SarcomaNCT05747521Henan Cancer Hospital85
招募中
早期 1 期
EGFR/B7H3 CAR-T on Lung Cancer and Triple Negative Breast CancerEGFR/ B7H3-positive Advanced Lung CancerEGFR/ B7H3-positive Advanced Triple-negative Breast CancerNCT05341492Second Affiliated Hospital of Guangzhou Medical University30
尚未招募
3 期
Fluzoparib in Combination With Apatinib Mesylate for Maintenance Therapy in Stage III-IV Ovarian CancerEfficacySafetyBone Mineral DensityTolerabilityEpithelial Ovarian CancerNCT06539091Anhui Provincial Hospital51