Clinical trial NCT04207918: A Phase II Study of Chemoradiotherapy With Nimotuzumab in Unresectable Esophageal Cancer
Official title: A Phase II Study of Chemoradiotherapy With Nimotuzumab in Unresectable Esophageal Squamous Cell Carcinoma Based on Nutritional Risk Screening Score (NRS2002)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Cancer
Chemoradiotherapy
Nimotuzumab
Unresectable Malignant Neoplasm
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase II clinical study is designed to evaluate the 1 year local tumor control rates after the targeted therapy of intensity-modulated radiation therapy synchronized chemotherapy with nimotuzumab combined with S-1 in local advanced esophageal squamous cell carcinomas based on Nutritional Risk Screening NRS2002.


Eligibility criteria: Inclusion Criteria:

* ≥18 years
* Pathologically or cytologically proven esophageal squamous cell carcinomas in patients staged as T2-4N0-1M0-1b (AJCC 6th TNM staging, M1b limited to clavicular or celiac lymph node metastasis)
* Primary treatment accepted in Chinese Academy of Medical Sciences
* KPS ≥70
* NRS score ≥2
* Cervical or thoracic esophageal cancer histologically proved esophageal cell carcinoma
* Normal organ and marrow function as defined below:

Hemoglobin: greater than or equal to 100g/L ;Leukocytes: greater than or equal to 3,500 G/L; Neutrophil: greater than or equal to 1,500 G/L; Platelets: greater than or equal to 100,000/mm3 ; Creatinine within normal upper limits; BUN within normal upper limits; AST/ALT: less than or equal to 1.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; Alkaline phosphatase :less than or equal to 1.5 times the upper limit

* Informed consent

Exclusion Criteria:

* Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer
* Any prior chemotherapy or other cancer treatment prior to this protocol
* With any distant metastasis in liver, lung, bone, CNS or peritoneal transplantation
* History of allergic reactions attributed to contrast medium, similar chemical or biologic complex
* Existing esophageal fistula, perforation and cachexia
* Existing active infection such as active tuberculosis and hepatitis
* Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
* History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
* Participation in other clinical trials currently or within 4 weeks of selection
* Pregnant or lactating females

Primary outcomes:
measure: Local control rate
timeFrame: 1 year
Secondary outcomes:
measure: Number of Participants with acute toxicities
timeFrame: 2-3 months
measure: R0 resection rate
timeFrame: 2-3 months
measure: Pathological response rate
timeFrame: 2-3 months
measure: Tumor Response rate
timeFrame: 2-3 months
measure: Incidence of perioperative complications
timeFrame: 2-3 months
measure: Overall survival
timeFrame: 1 year, 2 year
measure: Progression free survival
timeFrame: 1 year, 2 year
measure: Texture analysis of CT and/or MRI simulation in predicting tumor response rate and prognosis
timeFrame: 1 year, 2 year
measure: ctDNA in predicting tumor response rate and prognosis
timeFrame: 1 year, 2 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Study officials:
References: