Nimotuzumab Concurrent With Chemoradiotherapy for Patients With Unresectable Esophageal Squamous Cell Carcinoma
NCT ID: NCT06410651
Last Updated: 2024-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
53 participants
INTERVENTIONAL
2023-03-01
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nimotuzumab concurrent with chemordiotherapy followed by surgery
Nimotuzumab with chemoradiotherapy
Radiotherapy, 40-50.4Gy/20-28f. Nimotuzumab 400mg, ivgtt, W2d. Chemotherapy, S-1, 40-60mg/m2, on BSA，orally twice daily on radiotherapy days.
Interventions
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Nimotuzumab with chemoradiotherapy
Radiotherapy, 40-50.4Gy/20-28f. Nimotuzumab 400mg, ivgtt, W2d. Chemotherapy, S-1, 40-60mg/m2, on BSA，orally twice daily on radiotherapy days.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Responsible Party
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XIN WANG
Principal Investigator
Locations
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National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCC4536
Identifier Type: -
Identifier Source: org_study_id
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