Nimotuzumab with Chemoradiotherapy for Esophageal Cancer

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

This study is testing if a combination of a new antibody treatment, chemotherapy, and radiation can help older or malnourished patients with advanced esophageal cancer feel better and improve their chances of recovery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Academic / other)
• Drugs / interventions: chemotherapy, radiation, Nimotuzumab
• Locations: 1 site (Beijing)
• Trial ID: NCT06429839 on ClinicalTrials.gov

What this trial studies

This phase II trial evaluates the efficacy and safety of a combination treatment involving the monoclonal antibody nimotuzumab, chemotherapy, and concurrent radiotherapy in elderly or malnourished patients with unresectable esophageal squamous cell carcinoma (ESCC). The study aims to assess outcomes such as the rate of complete pathological response and treatment-related toxicity. It is a one-arm trial, meaning all participants will receive the same treatment regimen without a control group. The focus is on improving treatment outcomes for a population that typically has a poor prognosis.

Who should consider this trial

Good fit: Ideal candidates are elderly or malnourished patients diagnosed with locally advanced esophageal squamous cell carcinoma who have not received prior treatment.

Not a fit: Patients with previous treatments for esophageal cancer or those with distant metastases beyond the supraclavicular lymph nodes may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with advanced esophageal cancer.

How similar studies have performed: Previous studies have shown the efficacy and safety of nimotuzumab in esophageal cancer, suggesting that this approach may be promising.

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.

Where this trial is running

Beijing

• National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Xin Wang, Doctor

Conditions Esophageal Cancer; Nimotuzumab; Chemoradiotherapy; Chemotherapy; Immunotherapy