Clinical trial · Interventional
Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old Age
NCT06048913CI-TRIAL-00091790completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The research subjects of this project are mainly aimed at patients with locally advanced esophageal cancer who cannot be treated surgically, in nimotuzumab 3 months after the end of concurrent chemoradiotherapy, RECIST is pressed as based on physical examination and esophageal barium dialysis or esophageal contrast-enhanced CT Criteria assessed short-term and long-term efficacy separately. By detecting the expression of EGFR in patients with locally advanced esophageal cancer, the relationship between the efficacy of EGFR monoclonal antibody therapy and the long-term prognosis of patients was evaluated. Evaluation of safety, toxicity and side effects during treatment and in the near and long term.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Carcinoma | Esophageal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Concurrent radiation therapy | Radiation | — | UNRESOLVED |
| Nimotuzumab | Drug | Nimotuzumab | ALIAS |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nimotuzumab combined with concurrent chemoradiotherapy
- description
- Treatment options Nimotuzumab （400mg plus normal saline 250ml intravenous infusion for not less than 60 minutes. Starting from week 1 of radiotherapy, 1 dose of the same dose each time for a total of 6 doses）combined with chemoradiotherapy (Oral chemotherapy with the tigio regimen is given on days 1 to 2 of radiotherapy, with the drug dose calculated based on body surface area, and the oral S-1 course from Monday to Friday is synchronized with radiation therapy) for the treatment of locally advanced elderly esophageal cancer patients, in which the S-1 regimen with good clinical tolerability was selected for chemotherapy to evaluate the short-term efficacy and toxic side effects
- interventionNames
- Drug: Nimotuzumab
- Drug: S-1
- Radiation: Concurrent radiation therapy
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- up to 3 years
- description
- Progression-free survival was measured from the treatment initiation to either tumor progression (in any form) or death from any cause
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with stage II-IVB according to AJCC (8th edition, 2018) (IVB included metastasis to the celiac trunk or supraclavicular lymph nodes only) who are not suitable for or refuse surgery can tolerate concurrent chemoradiotherapy and targeted therapy; 2. The pathological type is esophageal squamous cell carcinoma; 3. Eastern Cooperative Oncology Group performance status of 0-1, age ≥ 75 years old; 4. No serious comorbidities, such as severe obstructive emphysema, hypertension, coronary heart disease, diabetes and psychiatric history, etc., and no other malignant tumors; 5. All patients had not received EGFR-targeted therapy, immunotherapy, and chemoradiotherapy; 6. Expected survival time ≥ 12 weeks. Exclusion criteria Patients who meet any of the following criteria will be excluded from this trial: 1. Received EGFR monoclonal antibody or EGFR-TKI within six months; 2. Participated in other interventional clinical trials within 30 days before screening; 3. Patients with serious concurrent diseases, such as heart failure, high-risk uncontrollable arrhythmias, severe myocardial infarction, refractory hypertension, renal failure (CKD-4 and above), thyroid dysfunction, mental illness, diabetes, severe chronic diarrhea (more than 7 bowel movements per day), or patients who are considered unsuitable to participate in this clinical study by the researchers; 4. Patients with brain metastases with symptoms or symptom control time of less than 3 months; 5. Having a history of other malignant tumors (except for cured cervical carcinoma in situ or basal cell carcinoma of the skin and other malignant tumors that have been cured for more than 5 years); 6. The presence of active infection or active infectious disease; 7. Patients with multi-segment esophageal malignant tumors or signs of esophageal fistula or perforation; 8. Patients whose tumors have invaded important blood vessels as shown by imaging or who are judged by the researchers to be very likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study; 9. Those who are allergic to the drugs or their ingredients used in this program; 10. Peripheral neuropathy or hearing loss of grade 2 or higher according to the criteria of Common Terminology for Adverse Events (NCI CTCAE V5.0); 11. Pregnant or breastfeeding women; 12. Patients with a history of psychotropic drug abuse and unable to quit or patients with mental disorders; 13. Those who are considered unsuitable to participate in this study by the researcher; 14. Those who are unwilling to participate in this study or unable to sign the informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.