Actively Recruiting
Nimotuzumab Concurrent With Chemoradiotherapy for Patients With Unresectable Esophageal Squamous Cell Carcinoma
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-05-13
53
Participants Needed
1
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) who failed to induction chemo(immuno)therapy 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 and S-1 and concurrent radiotherapy for patients who are not sensitive to induction chemo(immuno)therapy.
CONDITIONS
Official Title
Nimotuzumab Concurrent With Chemoradiotherapy for Patients With Unresectable Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed esophageal squamous cell carcinoma.
- Tumor response after induction chemo(immuno)therapy evaluated as stable, locoregionally progressive, or unresectable without distant metastasis.
- Received 2 to 4 cycles of induction chemo(immuno)therapy.
- Karnofsky Performance Status (KPS) score of 70 or higher.
- Normal function of main organs and bone marrow: hemoglobin 100 g/L, absolute neutrophil count 1.5�d7 10^9/L, platelets 100�d7 10^9/L, white blood cell count 3.5�d7 10^9/L.
- Liver function tests: alanine aminotransferase and aspartate aminotransferase 1.5 times the upper normal limit (UNL).
- Serum total bilirubin 1.5 times UNL.
- Serum creatinine between 1.0 and 1.5 times UNL.
- Blood urea nitrogen (BUN) 1.0 times UNL.
You will not qualify if you...
- Presence of other primary malignant tumors besides esophageal cancer, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.
- Distant or hematogenous metastases beyond the supraclavicular lymph node region, including retroperitoneal multiple lymph node metastasis, bone, brain, lung, liver metastasis, malignant pleural effusion, or ascites.
- Active infections such as active tuberculosis or hepatitis.
- Contraindications to targeted therapy.
AI-Screening
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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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