Skip to main content
OpenTrials
Completed

NCT Number: NCT04207918

A Phase II Study of Chemoradiotherapy With Nimotuzumab in Unresectable Esophageal Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Esophageal Cancer Chemoradiotherapy Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Nimotuzumab Unresectable Malignant Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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)

Beijing, 100021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiotherapy

Radiation

44.94Gy and 37.8Gy in 21 fractions to PGTV and PTV for neoadjuvant treatment. 59.92Gy and 50.4Gy in 28 fractions to PGTV and PTV for definitive treatment.

Nimotuzumab

Drug

400mg, by intravenous infusion once a week in 4-6 weeks.

S-1

Drug

40-60mg/m2/d，orally twice a day concurrently with radiotherapy.

Primary outcomes

  1. Local control rate

    Time frame: 1 year

Secondary outcomes

  1. Number of Participants with acute toxicities

    Time frame: 2-3 months

    Acute toxicities are evaluated by NCI-CTC version 5.0

  2. R0 resection rate

    Time frame: 2-3 months

    The surgical procedure was radical esophagectomy after neoadjuvant therapy.

  3. Pathological response rate

    Time frame: 2-3 months

    Pathological response were classified into five grades according to Mandard Tumor Regression Grade.

  4. Tumor Response rate

    Time frame: 2-3 months

  5. Incidence of perioperative complications

    Time frame: 2-3 months

    During hospital stay and within the first 30 days after completion of surgery.

  6. Overall survival

    Time frame: 1 year, 2 year

  7. Progression free survival

    Time frame: 1 year, 2 year

  8. Texture analysis of CT and/or MRI simulation in predicting tumor response rate and prognosis

    Time frame: 1 year, 2 year

  9. ctDNA in predicting tumor response rate and prognosis

    Time frame: 1 year, 2 year

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

A Phase II Study of Chemoradiotherapy With Nimotuzumab in Unresectable Esophageal Squamous Cell Carcinoma Based on Nutritional Risk Screening Score (NRS2002)

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Dec 23, 2019
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.