Actively Recruiting
Nimotuzumab Concurrent With Chemoradiotherapy for Esophageal Cancer Patients
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-05-28
55
Participants Needed
1
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Elderly or malnourished patients diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) had poor prognosis. Radiotherpy was an important and effective treatment in treating ESCC. The present study is a one-arm trial that seeks to evaluate the efficacy in patients with unresectable ESCC. The study objectives include R0 resection rate, complete pathological response and treatment toxicity, etc. Nimotuzumab is a recombinant humanized monoclonal antibody against EGFR. Its efficacy and safety in patients with esophageal cancer have been confirmed by many studies. The current prospective phase II study aimed to evaluate the efficacy and safety of a combination regimen comprising chemotherapy with nimotuzumab with a dose of 800mg per week and S-1 and concurrent radiotherapy for patients who are elderly or malnourished.
CONDITIONS
Official Title
Nimotuzumab Concurrent With Chemoradiotherapy for Esophageal Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed esophageal squamous cell carcinoma
- No previous treatment for esophageal carcinoma
- Karnofsky Performance Status (KPS) score of 70 or higher
- Nutritional Risk Screening 2002 (NRS-2002) score of 2 or more
- Normal function of main organs and bone marrow as shown by blood tests: hemoglobin (Hb) at least 100 g/L, absolute neutrophil count (NEUT) at least 1.5 x 10^9/L, platelets (PLT) at least 100 x 10^9/L, white blood cells (WBC) at least 3.5 x 10^9/L
- Normal biochemical tests including alanine aminotransferase (ALT) and aspartate aminotransferase (AST) up to 1.5 times the upper normal limit (UNL)
- Serum total bilirubin (TBIL) up to 1.5 times UNL
- Serum creatinine (Cr) between 1.0 to 1.5 times UNL
- Blood urea nitrogen (BUN) up to 1.0 times UNL
You will not qualify if you...
- Previous treatment of esophageal cancer with surgery, radiation, or chemotherapy
- Presence of other primary malignant tumors except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix
- Distant or hematogenous metastases beyond the supraclavicular lymph nodes, including multiple lymph node metastases in the retroperitoneum, bone, brain, lung, or liver metastases, malignant pleural effusion, or ascites
- Active infections such as active tuberculosis or hepatitis
- Contraindications to targeted therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
Actively Recruiting
Research Team
X
Xin Wang, Doctor
CONTACT
G
Guojie Feng, B.M
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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