RECRUITINGPhase 2INTERVENTIONAL

Nimotuzumab Concurrent With Chemoradiotherapy for Patients With Unresectable Esophageal Squamous Cell Carcinoma

Nimotuzumab Concurrent With Chemoradiotherapy for Patients With Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma After Failure of Chemotherapy：A Phase II Study

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - diagnosed by tissue sample (biopsy-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; Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

COMBINATION_PRODUCT

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.

Locations (1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China