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investigators plan to conduct a multicenter, prospective, randomized controlled, open, phase clinical study to compare the efficacy and safety of nimotuzumab with concurrent chemoradiation alone in elderly participants with advanced esophageal squamous cell carcinoma.
investigators plan to conduct a multicenter, prospective, randomized controlled, open, phase clinical study to compare the efficacy and safety of nimotuzumab with concurrent chemoradiation alone in elderly participants with advanced esophageal squamous cell carcinoma. The enrolled participants will be randomly ized into the trial and control group according to 1:1. The test group received nimotuzumab and radiotherapy; the control group received Tigio and radiotherapy. This study includes the screening period, treatment period, efficacy follow-up period, and survival follow-up period
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nimotuzumab plus concurrent chemoradiotherapy group | Experimental | S-1: TBSA<1.4 m²,40mg;TBSA=1.4-1.6 m²,50mg;TBSA>1.6 m²,60mg,po,BID, During the synchronous period of radiotherapy,QW,D1-D5, After radiotherapy,Q3W,D1-14,lasting for 1 year Nimotuzumab 400mg, iv, D1, Week 1; Nimotuzumab 200mg, iv, D8, QW, weeks 2-5. The prescribed dose required 95%PTV 50.4Gy/1.8Gy/28f SIB-PGTV 59.92Gy/2.14Gy/28 次 |
|
| concurrent chemoradiotherapy group alone | Active Comparator | S-1: TBSA<1.4 m²,40mg;TBSA=1.4-1.6 m²,50mg;TBSA>1.6 m²,60mg,po,BID, During the synchronous period of radiotherapy,QW,D1-D5, After radiotherapy,Q3W,D1-14,lasting for 1 year The prescribed dose required 95%PTV 50.4Gy/1.8Gy/28f SIB-PGTV 59.92Gy/2.14Gy/28 次 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimotuzumab | Drug | Nimotuzumab 400mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | PFSProgression-Free-Survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
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Inclusion Criteria:
1) Blood routine examination:
a.ALB≥30g/L; B. ALT and AST≤2.5ULN; ALT and AST 5 ULN; c.TBIL≤1.5ULN; D. Plasma Cr≤1.5ULN or creatinine clearance (CCr) of 60 ml/min; 9. Echocardiographic assessment: left ventricular ejection fraction (LVEF) low normal value (50%); 10. Women of childbearing age should agree to use contraception (e. g. intrauterine devices, contraceptives or condoms) during the study and within 6 months after the study; serum or urine pregnancy tests were negative within 7 days before study enrollment and must be non-lactating patients; men who agree to use contraception during the study and within 6 months after the end of the study period.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaolin MM GE, PHD | Contact | 13951818797 | doctorsxl@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaolin MM GE | The First Affiliated Hospital with Nanjing Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | China |
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| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C501466 | nimotuzumab |
| D005641 | Tegafur |
| C079198 | S 1 (combination) |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 |
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| Tegafur | Drug | S-1 60mg/m2 |
|
|
| radiotherapy | Radiation | PTV 50Gy/2Gy |
|
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |