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Recruiting NCT06429839

Nimotuzumab Concurrent With Chemoradiotherapy for Esophageal Cancer Patients

Phase II Interventional Esophageal Cancer Nimotuzumab Chemoradiotherapy Chemotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nimotuzumab with chemoradiotherapy.
Who it may be relevant to
Registry conditions: Esophageal Cancer, Nimotuzumab, Chemoradiotherapy, Chemotherapy. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Nimotuzumab Concurrent With Chemoradiotherapy for Elderly or Malnourished Patients With Unresectable Esophageal Squamous Cell Carcinoma: A Phase II Study

Overview

Elderly or malnourished patients diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) 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 with a dose of 800mg per week and S-1 and concurrent radiotherapy for patients who are elderly or malnourished.

Interventions

  • 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.

Primary outcome measures

  • R0 resection rate [Time frame: 4 months after initiation of induction chemoimmunotherapy]
Secondary outcome measures (4)
  • Pathological complete response [Time frame: 4 months after initiation of induction chemoimmunotherapy]
  • Event-free survival [Time frame: 1 month after chemoradiotherapy]
  • Postoperative complications [Time frame: 1 month after surgery]
  • Overall survival [Time frame: 1 year after all treatment]

Eligibility criteria

Inclusion criteria

  • Histologically confirmed esophageal squamous cell carcinoma.
  • No previous treatment for the esophageal carcinoma.
  • KPS score ≥70.
  • NRS-2002 score≥2.
  • 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

  • Previous treatment of the esophageal cancer with surgery, radiation, or chemotherapy.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chine — Beijing

Identifiers

NCT: NCT06429839 · NCC4571

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗