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.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 55 (estimated) |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | chemotherapy, radiation, Nimotuzumab |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | March 1, 2023 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | May 28, 2024 |
| Trial ID | NCT06429839 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
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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.
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Nimotuzumab with Chemoradiotherapy for Unresectable Esophageal Cancer
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.
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Combining immunotherapy and chemoradiotherapy for esophageal cancer treatment
This study is testing if combining a new immunotherapy drug with traditional chemoradiotherapy can help people with advanced esophageal cancer have better treatment results.
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Using sintilimab after chemoradiotherapy for elderly patients with esophageal cancer
This study is testing if adding a new treatment called sintilimab after chemotherapy and radiation can help older patients with esophageal cancer live longer and healthier.
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β-hydroxybutyrate with short-course radiotherapy, immunotherapy and CAPEOX before surgery for locally advanced rectal cancer
This phase II trial will test whether adding β-hydroxybutyrate supplements to short-course radiotherapy followed by immunotherapy plus CAPEOX chemotherapy improves outcomes for people with locally advanced rectal cancer before surgery.
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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.
This trial tests whether adding a PD‑1 immunotherapy to short-course radiotherapy followed by CAPOX and bevacizumab helps adults with locally advanced rectal cancer get a higher complete response rate and fewer distant metastases.
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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.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.