Clinical trial · Interventional
A Phase II Study of Chemoradiotherapy With Nimotuzumab in Unresectable Esophageal Cancer
A Phase II Study of Chemoradiotherapy With Nimotuzumab in Unresectable Esophageal Squamous Cell Carcinoma Based on Nutritional Risk Screening Score (NRS2002)
NCT04207918CI-TRIAL-00077169completedPhase 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)
This phase II clinical study is designed to evaluate the 1 year local tumor control rates after the targeted therapy of intensity-modulated radiation therapy synchronized chemotherapy with nimotuzumab combined with S-1 in local advanced esophageal squamous cell carcinomas based on Nutritional Risk Screening NRS2002.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemoradiotherapy | — | UNRESOLVED | — |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Nimotuzumab | — | UNRESOLVED | — |
| Unresectable Malignant Neoplasm | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nimotuzumab | Drug | Nimotuzumab | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant Chemoradiotherapy（NCRT）
- description
- NCRT arm receives intensity-modulated radiotherapy concurrently with S-1（40-60/m2/d，orally twice a day） and nimotuzumab（400mg/d，by intravenous infusion once a week）.
- interventionNames
- Radiation: Radiotherapy
- Drug: Nimotuzumab
- Drug: S-1
Primary outcomes (1)
- measure
- Local control rate
- timeFrame
- 1 year
Secondary outcomes (9)
- measure
- Number of Participants with acute toxicities
- timeFrame
- 2-3 months
- description
- Acute toxicities are evaluated by NCI-CTC version 5.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥18 years * Pathologically or cytologically proven esophageal squamous cell carcinomas in patients staged as T2-4N0-1M0-1b (AJCC 6th TNM staging, M1b limited to clavicular or celiac lymph node metastasis) * Primary treatment accepted in Chinese Academy of Medical Sciences * KPS ≥70 * NRS score ≥2 * Cervical or thoracic esophageal cancer histologically proved esophageal cell carcinoma * Normal organ and marrow function as defined below: Hemoglobin: greater than or equal to 100g/L ;Leukocytes: greater than or equal to 3,500 G/L; Neutrophil: greater than or equal to 1,500 G/L; Platelets: greater than or equal to 100,000/mm3 ; Creatinine within normal upper limits; BUN within normal upper limits; AST/ALT: less than or equal to 1.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; Alkaline phosphatase :less than or equal to 1.5 times the upper limit * Informed consent Exclusion Criteria: * Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer * Any prior chemotherapy or other cancer treatment prior to this protocol * With any distant metastasis in liver, lung, bone, CNS or peritoneal transplantation * History of allergic reactions attributed to contrast medium, similar chemical or biologic complex * Existing esophageal fistula, perforation and cachexia * Existing active infection such as active tuberculosis and hepatitis * Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness * History of myocardial infarction within the past 6 months or history of ventricular arrhythmia * Participation in other clinical trials currently or within 4 weeks of selection * Pregnant or lactating females
References
Publications (0)
Data not yet available
No reference posted for this study.