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This is a prospective, single-arm, open-label,multi-center, phase II study, aiming to evaluate the efficacy and safety of AK104 combined with preoperative chemotherapy in patients with locally advanced ESCC.
Eligible patients first receive AK104 (10mg/kg, iv, Q2W) for one cycle in the induction period, and then patients receive AK104 (10mg/kg, iv, Q3W) combined with nab-paclitaxel (130mg/m2 ivgtt d1,d8, Q3W) and carboplatin ((AUC=5) d1,Q3W) for 2 cycles. After neoadjuvant therapy of 3 cycles, patient will undergo preoperative evaluation. For patients who can be performed for R0 surgery, surgery wil be performed in 4 to 6 weeks. Patients who do not achieve Pathological complete response (pCR) will receive AK104 (10mg/kg, iv, Q3W) as adjuvant therapy until disease progression or intolerable toxicity for up to 12 months. Patients who achieve pCR after surgery will be enrolled in observational follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK104 plus nab-paclitaxel and carboplatin | Experimental | In the induction period, AK104 (10mg/kg, iv, Q2W) is given for one cycle; and then AK104 (10mg/kg, iv, Q3W) is combined with nab-paclitaxel (130mg/m2 ivgtt d1,d8, Q3W) and carboplatin ((AUC=5) d1,Q3W) for 2 cycles; After R0 surgery, AK104 (10mg/kg, iv, Q3W) is given as adjuvant therapy for up to 12 months for those who do not achieve pCR. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK104, nab-paclitaxel, carboplatin | Drug | AK104 plus nab-paclitaxel and carboplatin as neoadjuvant therapy,and AK104 as adjuvant therapy for those who do not achieve pCR; |
|
| Measure | Description | Time Frame |
|---|---|---|
| pCR | Pathological complete response | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| MPR | Major pathologic response | up to 2 years |
| R0 resection rate | R0 resection rate | up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Wang | Contact | 13938244776 | fengw010@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Feng Wang | The First Affiliated Hospital of Zhengzhou University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anyang Cancer Hospital | Anyang | Henan | 450052 | China |
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|
| Downstaging rate | Downstaging rate | up to 2 years |
| DFS | Disease-free survival | up to 2 years |
| OS | Overall survival | up to 2 years |
| AE | Adverse event | up to 2 years |
| Feng Wang | Zhengzhou | Henan | 450052 | China |
|
| 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 |
| 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 |
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| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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