Nimotuzumab with Chemoradiotherapy for Unresectable Esophageal Cancer

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

This study is testing if adding a new drug called nimotuzumab to chemotherapy and radiation can help patients with advanced esophageal cancer who haven't improved with earlier treatments.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (other)
• Drugs / interventions: Nimotuzumab, chemotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT06410651 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial evaluates the efficacy and safety of nimotuzumab, a monoclonal antibody, combined with chemotherapy and concurrent radiotherapy in patients with unresectable esophageal squamous cell carcinoma (ESCC) who have not responded to prior induction therapy. The study aims to assess outcomes such as the rate of complete pathological response and treatment-related toxicity. It is a one-arm trial focusing on patients with locally advanced ESCC, specifically those who have stable or progressive disease after initial treatment. The trial is conducted at the Cancer Institute and Hospital, Chinese Academy of Medical Sciences.

Who should consider this trial

Good fit: Ideal candidates include patients with histologically confirmed unresectable esophageal squamous cell carcinoma who have undergone 2-4 cycles of induction chemotherapy and have a KPS score of 70 or higher.

Not a fit: Patients with distant metastases or those with other primary malignancies may not benefit from this study.

Why it matters

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

How similar studies have performed: Previous studies have shown promising results for nimotuzumab in esophageal cancer, indicating potential for success with this combined treatment approach.

Eligibility criteria

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.

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