A Multicenter, Randomized Controlled, Phase II Clinical Study of First-line Chemotherapy and Camrelizumab With or Without Radiotherapy in the Treatment of Oligometastatic Esophageal Cancer
研究概览
详细说明
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名:yongling Ji, MD
- 电话号码:13958085251
- 邮箱:wangjin@zjcc.org.cn
研究联系人备份
- 姓名:jin Wang, Master
- 电话号码:18858165856
- 邮箱:Jiyl@zjcc.org.cn
学习地点
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Zhejiang
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Hangzhou、Zhejiang、中国、310022
- ZheJiang Cancer Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age ≥18 years old and ≤75 years old, regardless of gender;
- Histologically or cytologically confirmed recurrent or metastatic esophageal squamous cell carcinoma;
- Non-regional lymph node metastasis, such as upper neck, retroperitoneal or axillary lymph node metastasis; or distant metastasis, but no more than 3 metastatic organs, and no more than 5 lesions;
- Patients who have not received other systems of anti-tumor treatment; the patients who have received neoadjuvant/adjuvant and radical concurrent radiochemotherapy, and the last treatment time or progress time exceeds 6 months;
- Patients who have not progressed after receiving 4 courses of chemotherapy combined with PD-1 immune checkpoint inhibitor treatment (according to the RECIST 1.1 evaluation standard);
- There are measurable lesions according to the RECIST 1.1 standard (cavity structures such as the esophagus cannot be used as measurable lesions), and the measurable lesions should not have received local treatment such as radiotherapy;
- ECOG PS score is 0~1;
- For non-surgically sterilized female patients of childbearing age, the serum or urine HCG test must be negative within 72 hours before randomization;
- Volunteer to participate in clinical research: fully understand and know the research and sign the Informed Consent Form (ICF); willing to follow and have the ability to complete all trial procedures;
- Have not received immunotherapy or biological therapy before;
- Hemoglobin ≥90g/L, platelets ≥10×10 9 /L, absolute neutrophil count ≥1.5×10 9 /L;
- Serum creatinine ≤ 1.5 times UNL;
- Serum bilirubin≤1.5×UNL, AST (SGOT) and ALT (SGPT)≤2.5×UNL, alkaline phosphatase≤5×UNL;
- Coagulation function: INR≤1.5 × ULN; if the patient is receiving anticoagulation therapy, PT or APTT is within the acceptable range of treatment;
- There was no history of interstitial pneumonia or previous interstitial pneumonia.
Exclusion Criteria:
- In addition to the systemic treatment recommended by this program, patients have received other immune checkpoint inhibitor treatments such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies in the past, or any other antibodies or drugs with specific targets for T cell costimulation or checkpoint pathways;
- Patients have received radiotherapy in the past, and the tumor in the irradiation field has progressed;
- BMI<18.5kg/m 2 , or weight loss >10% within 2 months before screening ;
- With brain metastases;
- With metastasis of the meninges, pleura or pericardium;
- Esophageal perforation and active esophageal bleeding, with invasion of trachea and large blood vessels in the thoracic cavity;
- Those who confirmed tumor progression during systemic treatment (RECIST 1.1 standard);
- Severe symptoms of dysphagia caused by tumor compression require immediate radiotherapy intervention to relieve the obstruction;
- Systemic treatment toxicity did not return to ≤ CTCAE level 1 (except for hair loss) or the level specified by the inclusion/exclusion criteria;
- Subjects have cardiovascular diseases or clinical symptoms that are not well controlled, including but not limited to: (1) Heart failure above NYHA II; (2) Unstable angina; (3) Myocardial infarction within 1 year; ( 4) Clinically significant supraventricular tachycardia or ventricular arrhythmia without clinical intervention, or poor control after clinical intervention;
- Patients with severe lung disease, interstitial pneumonia, or previous history of interstitial pneumonia:
- Autoimmune diseases (such as: systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease), but allow the following diseases to enter the next step of screening: type I diabetes, skin diseases that do not require systemic treatment ( Such as vitiligo, psoriasis);
- Patients have active hepatitis B (HBV DNA≥2000IU/L or 104copies/ml) or hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the detection limit of the analysis method);
- Suffered from an active infection requiring systemic treatment 14 days before the first administration;
- Patients with active pulmonary tuberculosis infection found through medical history or CT examination, or patients with a history of active pulmonary tuberculosis infection 1 year before enrollment, or patients with active pulmonary tuberculosis infection more than 1 year ago but without formal treatment;
- Patients with other malignant lesions, except for curable skin cancer (non-melanoma), cervical carcinoma in situ or malignant disease cured ≥ 5 years;
- Patients who cannot understand the test requirements or may not comply with the test requirements;
- The investigator believes that some obvious diseases should be excluded from this study;
- The dose limit of radiotherapy cannot meet the limit requirement set by this study.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Combined radiotherapy group
Chemotherapy :TP program (paclitaxel 175mg/m 2 d1, carboplatin AUC=5 d1 IV Q3W; or paclitaxel 175mg/m 2 d1, cisplatin 75mg/m 2 d1, or paclitaxel 175mg/m 2 d1, cis Platinum 25mg/m 2 d1-3 IV (Q3W, up to 4 cycles). Fluorouracil + cisplatin, cisplatin 80 mg/m 2 d1 IV and 5-Fu 800 mg/m 2 continuous IV d1-5 Q3W (up to 4 cycles).Or cisplatin 50mg/m 2 IV d1; LV 200mg/m 2 IV d1; 5-Fu 2000mg/m 2 24 hours continuous IV d1; or cisplatin 80mg/m 2 IV d1, capecitabine 1000mg/m 2 PO BID d1-14. Camrelizumab :200mg every 3 weeks,maximum 6 cycles. The experimental group received radiotherapy of the lesion within 8 weeks after the end of chemotherapy and immunotherapy. Immunotherapy shall be started within 8 weeks after the end of all radiotherapy. The maintenance immunotherapy of the two groups was: Camrelizumab 200mg Q3W, until PD or toxicity is intolerable or up to 24 months. |
Stereotactic body radiotherapy (SBRT, 8Gy/time, 3 -5 times, if other segmentation schemes are used, recommend BED10 >60Gy) or conventional fractional radiotherapy (parts that are not suitable for SBRT, the total dose is more than 30Gy); the primary lesion should be treated with conventional fractional radiotherapy with a dose of 4000cGy or more;
4 cycles for combined therapy.
Camrelizumab maintenance.
4 cycles for combined therapy.
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安慰剂比较:Non-radiotherapy group
Chemotherapy :TP program (paclitaxel 175mg/m 2 d1, carboplatin AUC=5 d1 IV Q3W; or paclitaxel 175mg/m 2 d1, cisplatin 75mg/m 2 d1, or paclitaxel 175mg/m 2 d1, cis Platinum 25mg/m 2 d1-3 IV (Q3W, up to 4 cycles). Fluorouracil + cisplatin, cisplatin 80 mg/m 2 d1 IV and 5-Fu 800 mg/m 2 continuous IV d1-5 Q3W (up to 4 cycles).Or cisplatin 50mg/m 2 IV d1; LV 200mg/m 2 IV d1; 5-Fu 2000mg/m 2 24 hours continuous IV d1; or cisplatin 80mg/m 2 IV d1, capecitabine 1000mg/m 2 PO BID d1-14. Camrelizumab :200mg every 3 weeks,maximum 6 cycles. The control group continued Camrelizumab after 3 weeks of the 4 cycles of chemotherapy combined with immunotherapy. The maintenance immunotherapy of the two groups was: Camrelizumab 200mg Q3W, until PD or toxicity is intolerable or up to 24 months. |
4 cycles for combined therapy.
Camrelizumab maintenance.
4 cycles for combined therapy.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Progression-free survival (PFS)
大体时间:Up to 24 month
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PFS, defined as the time from randomization to the first occurrence of disease progression.
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Up to 24 month
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Objective Response Rate (ORR)
大体时间:Up to 24 month
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The percentage of patients with CR and PR assessed by investigators according to Recist v 1.Subjects evaluated as CR and PR need to be confirmed after 4 weeks (the next curative effect evaluation time specified in the protocol).
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Up to 24 month
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Overall survival (OS)
大体时间:Up to 24 month
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OS, defined as the time from randomization to death due to any cause.
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Up to 24 month
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Adverse Events (AEs)
大体时间:Up to 24 month
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Adverse Events Monitor and evaluate the safety of the treatment during the whole course of treatment and 30 days after the end of the last treatment.
If severe toxicity occurs, monitor until 90 days after the end of treatment.According to CTCAE 5.0, the toxicity is classified and recorded.
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Up to 24 month
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Disease Control Rate (DCR)
大体时间:Up to 24 month
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The proportion of patients who have achieved CR,PR and SD assessed by investigators according to Recist v 1.1.
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Up to 24 month
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Duration of Response (DoR)
大体时间:Up to 24 month
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The duration of overall efficacy refers to the time period from the first evaluation of CR/PR (whichever occurs first) to relapse or PD; the duration of SD refers to the time the subjects were enrolled in this study (The day of enrollment) The time period to PD.
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Up to 24 month
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合作者和调查者
合作者
调查人员
- 首席研究员:yongling Ji, MD、ZheJiang Cancer Hospital
- 首席研究员:Ming Chen, MD、Sun Yet-sen Cancer Center
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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