Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to learn if immunotherapy in combination with tumor draining lymph nodes-sparing radiotherapy (TDLN-sparing RT) and chemotherapy works to treat locally advanced esophageal squamous cell cancer in adults.
Researchers will compare immunotherapy in combination with TDLN-sparing RT and chemotherapy to TDLN-sparing RT and chemotherapy to see if immunotherapy works more effectively when using TDLN-sparing RT to treat locally advanced esophageal squamous cell cancer
Participants will:
TDLN-sparing RT for esophageal cancer 50.4Gy/28Fx Paclitaxel plus cisplatin every 3 weeks for 4 cycles PD-1 inhibitors or observation every 3 weeks for 1 year
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concurrent Immunotherapy plus TDLN-sparing RT and Chemotherapy | Experimental | PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year. Paclitaxel 135mg/m2 d1, cisplatin 25mg/m2 d1-3, once every 3 weeks for 4 cycles, or other guideline recommended regimens for 4 cycles. TDLN-sparing radiotherapy 50.4Gy/28Fx. |
|
| TDLN-sparing RT and Chemotherapy | Active Comparator | Paclitaxel 135mg/m2 d1, cisplatin 25mg/m2 d1-3, once every 3 weeks for 4 cycles, or other guideline recommended regimens for 4 cycles. TDLN-sparing radiotherapy 50.4Gy/28Fx. It is allowed to accept immunotherapy followed by radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunotherapy | Drug | PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS for patients with TDLN V15 ≤ 50% | 2 years | |
| PFS for all patients | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| OS for patients with TDLN V15 ≤ 50% | 2 years | |
| OS for all patients | 2 years | |
| Adverse events |
Not provided
Inclusion Criteria:
7. Eastern Cooperative Oncology Group(ECOG) performance status: 0-1 8. Life expectancy ≥3 months 9. Adequate organ functions Absolute neutrophil counts (ANC) ≥1.5×109⁄L; Hemoglobin (Hb) ≥9g⁄dl; Platelet (Plt) ≥100×109⁄L; Total bilirubin ≤1.5 upper limit of normal (ULN); Aspartate transaminase (AST) ≤2.5 ULN; Alanine aminotransferase (ALT) ≤2.5 ULN; Creatinine ≤1.5 ULN 10.Received no more than 3 cycles immunotherapy and/or chemotherapy
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dashan Zhao | Contact | +862164175590 | kuaile_z@sina.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D017606 | Chlorine Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| chemotherapy: Paclitaxel/Cisplatin or other guideline recommended regimens | Drug | Paclitaxel 135mg/m2 d1, cisplatin 25mg/m2 d1-3, once every 3 weeks for 4 cycles. or other guideline recommended regimens |
|
| TDLN-sparing RT | Radiation | TDLN-sparing radiotherapy 50.4Gy/28Fx. |
|
| up to 2 years |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D007287 |
| Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |