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| Name | Class |
|---|---|
| Beijing Bethune Charitable Foundation | UNKNOWN |
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The objective of this clinical trial is to determine whether the addition of immunotherapy combined with chemotherapy before chemoradiotherapy can increase the survival rate of patients with esophageal cancer. It will also assess the safety of this regimen. The primary questions it aims to answer include:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction group | Experimental | Patients receive induction therapy with sintilimab plus 3-weekly paclitaxel/carboplatin for 2 cycles, followed by concurrent chemoradiotherapy (weekly paclitaxel/carboplatin plus radiotherapy). |
|
| Standard group | Active Comparator | Patients receive concurrent chemoradiotherapy (weekly paclitaxel/carboplatin with radiotherapy), followed by 2 cycles of consolidation chemotherapy (4-weekly paclitaxel/carboplatin). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Biological | 200mg, once every three weeks, administered before concurrent chemoradiotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival rate | From the date of randomization to 3 years or until death, whichever comes first. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | From the date of randomization to 3 years or until disease progression or death, whichever occurs first. | |
| Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 | For the duration of treatment plus 30 days after the last dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinjun Ye | Jiangsu Cancer Institute & Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Cancer Hospital | Nanjing | Jiangsu | 210009 | China |
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| 3-Weekly Paclitaxel plus Carboplatin (TC) Chemotherapy | Drug | Three-weekly induction chemotherapy regimen: Paclitaxel (135 mg/m², d1) + Carboplatin (AUC=5, d1), administered every 21 days. |
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| Weekly TC Chemotherapy | Drug | Paclitaxel (50 mg/m², intravenous infusion on Day 1 of each week) combined with Carboplatin (AUC 2, intravenous infusion on Day 1 of each week), administered for 5 consecutive weeks as part of concurrent chemoradiotherapy. |
|
| Four-Weekly TC Consolidation Chemotherapy | Drug | Four-weekly consolidation chemotherapy regimen: Paclitaxel (175 mg/m², intravenous infusion on Day 1) combined with Carboplatin (AUC 5, intravenous infusion on Day 1), administered every 28 days for 2 cycles following concurrent chemoradiotherapy. |
|
| Definitive Radiotherapy | Radiation | Definitive radiotherapy administered at a total dose of 50.4 Gy in 28 daily fractions (1.8 Gy per fraction) over approximately 5.5 weeks, delivered concurrently with weekly chemotherapy. |
|
| Objective response rate | One month after the completion of treatment. |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
| D016190 | Carboplatin |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D013812 | Therapeutics |
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