Nimotuzumab Concurrent With Chemoradiotherapy for Patients With Unresectable Esophageal Squamous Cell Carcinoma
- Conditions
- ImmunotherapyEsophageal CancerChemoradiotherapyChemotherapyNimotuzumab
- Interventions
- Combination Product: Nimotuzumab with chemoradiotherapy
- Registration Number
- NCT06410651
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 53
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nimotuzumab concurrent with chemordiotherapy followed by surgery Nimotuzumab with chemoradiotherapy -
- Primary Outcome Measures
Name Time Method R0 resection rate 4 months after initiation of induction chemoimmunotherapy Minimal distance tumor/circumferential resection margin (CRM) \> 1 mm.
- Secondary Outcome Measures
Name Time Method Postoperative complications 1 month after surgery 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
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
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
Side effects during chemoradiotherpay 1 month after chemoradiotherapy the time from start of chemoradiotherapy to 1 month after chemoradiotherapy
Trial Locations
- 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