Chemoradiotherapy, Chemotherapy, Esophageal Cancer, Immunotherapy, Nimotuzumab
Conditions
Brief 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.
Interventions
COMBINATION_PRODUCTNimotuzumab 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.
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| R0 resection rate | 4 months after initiation of induction chemoimmunotherapy | Minimal distance tumor/circumferential resection margin (CRM) \> 1 mm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response | 4 months after initiation of induction chemoimmunotherapy | the complete remission of all viable cancer cells in any of the specimens from surgery, including the primary site and lymph nodes |
| Event-free survival | 1 year after all treatment | the time from start of induction chemo(immuno)therapy to progression, relapse, all-cause death, or the last day of follow-up |
| Side effects during chemoradiotherpay | 1 month after chemoradiotherapy | the time from start of chemoradiotherapy to 1 month after chemoradiotherapy |
| Postoperative complications | 1 month after surgery | — |
| Overall survival | 1 year after all treatment | the time from start of induction chemo(immuno)therapy to all-cause death, or the last day of follow-up |
Countries
China
Contacts
Primary ContactXin Wang, doctor
Backup ContactGuojie Feng, B.M
Outcome results
None listed