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Efficacy of Radiotherapy in Combination with S-1 and Nimotuzumab in Elderly Patients with Esophageal Cancer: A Prospective, Single-Arm Study

Efficacy of Radiotherapy in Combination with S-1 and Nimotuzumab in Elderly Patients with Esophageal Cancer: A Prospective, Single-Arm Study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110571
Enrollment
Unknown
Registered
2025-10-15
Start date
2019-10-11
Completion date
Unknown
Last updated
2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal cancer

Interventions

Experimental Group:Radiotherapy combined with S-1 and nimotuzumab

Sponsors

Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
70 Years to No maximum

Inclusion criteria

Inclusion criteria: The primary tumor was pathologically confirmed to be esophageal squamous cell carcinoma. 2.Charlson=4 points 3.AJCC/UICC Esophageal Cancer Staging (6th Edition) Clinical stage IIA to IVA. 4. Patients who are not suitable for surgery or who are eligible for surgery but refuse it. 5. Age >=70 years old. 6. The ECOG physical condition score ranges from 0 to 1. 7. There was no esophageal perforation or active esophageal bleeding, and no invasion of the trachea or major blood vessels in the thoracic cavity. 8. No previous chest chemotherapy, radiotherapy, immunotherapy or biological therapy has been administered. Serum hemoglobin >=100g/L, platelet count >=10×10^9/L, absolute neutrophil count >=1.5×10^9/L 10. Serum creatinine =60 mL/ min. Serum bilirubin =0.8L. 13. Patients sign the formal informed consent form to indicate that they understand this study complies with the hospital's policy and ethical requirements.

Exclusion criteria

Exclusion criteria: 1. Before the start of treatment in this trial, the patient had received chest radiotherapy, chemotherapy or surgical resection of esophageal cancer 2. Patients with esophageal cancer whose primary lesion is multifocal 3. The lower boundary of the primary esophageal lesion is less than 3cm away from the esophagogastric junction 4. Patients with severe cardiovascular or lung diseases. 5. Patients who cannot understand the trial requirements or may not comply with them 6. Abdominal lymph node metastasis 7. Those who have lost more than 10-15% of their weight 8. People with long-term poor blood sugar control due to diabetes 10. It is known that there is an allergic reaction of grade 3 to 4 to any treatment stage 11. Participated in other clinical trials within the past 30 days 12. Patients aged 80 or above with a score of 5 in the NRS2002 nutritional risk screening 13. Patients aged 80 or above, accompanied by diabetes, or chronic lung disease (such as chronic bronchopneumonia), or a history of myocardial infarction/congestive heart failure, or cerebrovascular disease 14. Some obvious diseases that the researchers believe should be excluded from this study

Design outcomes

Primary

MeasureTime frame
Overall survival;

Secondary

MeasureTime frame
Progression Free Survival;Short-term effect;Quality of life;Failure mode;Toxicities;

Countries

China

Contacts

Public ContactQiu Guoqin

Zhejiang Cancer Hospital

1154389861@qq.com+86 571 8380 7781

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026