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Trial Title:
Nimotuzumab Concurrent With Chemoradiotherapy for Patients With Unresectable Esophageal Squamous Cell Carcinoma
NCT ID:
NCT06410651
Condition:
Esophageal Cancer
Nimotuzumab
Chemoradiotherapy
Chemotherapy
Immunotherapy
Conditions: Official terms:
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Nimotuzumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
Nimotuzumab with chemoradiotherapy
Description:
Radiotherapy, 40-50.4Gy/20-28f. Nimotuzumab 400mg, ivgtt, W2d. Chemotherapy, S-1,
40-60mg/m2, on BSA，orally twice daily on radiotherapy days.
Arm group label:
Nimotuzumab concurrent with chemordiotherapy followed by surgery
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically confirmed esophageal squamous cell carcinoma. Tumor response was
evaluated as stable or locoregionally progresive disease or assessed by surgeons
being unresectable (without distant metastasis) after induction
chemo(immuno)therapy.
- Cycles of induction chemo(immuno)therapy was 2-4.
- KPS score ≥70.
- Main organs and bone marrow function are normal: routine blood tests: hemoglobin
(Hb) ≥100g/L ; absolute neutrophil count (NEUT)≥1.5×109/L; platelets (PLT)
≥100×109/L; white blood cell (WBC)≥3.5×109/L,biochemical examination: alanine
aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×UNL; serum total
bilirubin (TBIL) ≤1.5×UNL; serum creatinine ( Cr) 1.0×1.5UNL, and BUN≤1.0×UNL;
Exclusion Criteria:
- Those combined with other primary malignant tumors other than esophageal cancer
(except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- At the time of diagnosis, there were distant and hematogenous metastases beyond the
supraclavicular lymph node region, including retroperitoneal multiple lymph node
metastasis, bone metastasis, brain metastasis, lung metastasis, liver metastasis,
malignant pleural effusion and ascites
- There are active infections, such as active tuberculosis and hepatitis
- There are contraindications to targeted therapy.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Xin Wang, doctor
Phone:
13311583220
Email:
berly_wx2000@163.com
Start date:
March 1, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06410651
