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

NCT04207918 | Completed Phase 2 DMC

• 1 other identifier: 19/291-2075
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer; Chemoradiotherapy; Nimotuzumab; Unresectable Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• Local control rate

  1 year

Secondary Outcomes (9)

• Number of Participants with acute toxicities

  2-3 months

• R0 resection rate

  2-3 months

• Pathological response rate

  2-3 months

• Tumor Response rate

  2-3 months

• Incidence of perioperative complications

  2-3 months

Study Arms (1)

Neoadjuvant Chemoradiotherapy（NCRT）

EXPERIMENTAL

NCRT arm receives intensity-modulated radiotherapy concurrently with S-1（40-60/m2/d，orally twice a day） and nimotuzumab（400mg/d，by intravenous infusion once a week）.

Radiation: Radiotherapy; Drug: Nimotuzumab; Drug: S-1

Interventions

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.

Neoadjuvant Chemoradiotherapy（NCRT）

Nimotuzumab DRUG

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

Neoadjuvant Chemoradiotherapy（NCRT）

S-1 DRUG

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

Neoadjuvant Chemoradiotherapy（NCRT）

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

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

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Radiotherapy; nimotuzumab; S 1 (combination)

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 23, 2019
• Study Start: November 14, 2019
• Primary Completion: December 30, 2022
• Study Completion: June 30, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

CN (1)