Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 80

Nimotuzumab with Chemoradiotherapy for Esophageal Cancer

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

Run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · NCT06429839 · Data updated 2026-11-12

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.

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Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment55 (estimated)
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
Academic / other
Drugs / interventionschemotherapy, radiation, Nimotuzumab
Locations1 site (Beijing)
StatusRecruiting
StartedMarch 1, 2023
Main results expectedDecember 31, 2025
Study endsDecember 31, 2026
Registry record updatedMay 28, 2024
Trial IDNCT06429839 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

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

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.