Nimotuzumab with Chemoradiotherapy for Unresectable Esophageal Cancer

Is this trial a fit for you?

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 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.

Why it matters

Who can join: the full rules

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 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

• Study coordinator: Xin Wang, doctor
• Email: beryl_wx2000@163.com
• Phone: 13311583220

Similar studies

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

• Nimotuzumab with Chemoradiotherapy for Esophageal Cancer

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• β-hydroxybutyrate with short-course radiotherapy, immunotherapy and CAPEOX before surgery for locally advanced rectal cancer

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• Short-course pelvic radiotherapy followed by CAPOX (capecitabine + oxaliplatin) and bevacizumab, with or without PD‑1 immunotherapy, for locally advanced rectal cancer.

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  Recruiting Phase 2 Ruijin Hospital · Shanghai · NCT07198165

• Toripalimab plus capecitabine after chemoradiotherapy for esophageal squamous cell carcinoma

  This trial will test whether giving toripalimab together with low‑dose capecitabine after definitive chemoradiotherapy helps people with locally advanced esophageal squamous cell carcinoma live longer and have fewer recurrences.

  Recruiting Phase 3 Sun Yat-sen University · Guangzhou, Guangdong · NCT07177794

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.