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| Name | Class |
|---|---|
| Suzhou Suncadia Biopharmaceuticals Co., Ltd. | INDUSTRY |
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The purpose of this study is to explore the efficacy and safety of compare the efficacy and safety of PD-1 inhibitor and chemotherapy(treatment group) with chemoradiotherapy(control group) in neoadjuvant treatment of resectable thoracic esophageal squamous cell carcinoma.
This is a randomized, open-label, phase II study of PD-1 inhibitor combined With neoadjuvant chemotherapy versus neoadjuvant chemoradiotherapy in subjects With resectable locally advanced thoracic esophageal squamous cell carcinoma. The patients will be divided into two groups(1:1). In the treatment group, PD-1 inhibitor ,albumin-bound paclitaxel and cisplatin will be given every 3 weeks for 2-4 cycles as neoadjuvant therapy. In the control gourp, albumin-bound paclitaxel and cisplatin will be given every 3 weeks for 2 cycles as neoadjuvant therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD-1 Inhibitor+albumin-bound paclitaxel+cisplatin | Experimental | Participants receive PD-1 Inhibitor 200mg on Day 1 every 3 weeks (Q3W), albumin-bound paclitaxel 125 mg/m^2 on Day 1, 8 Q3W, and cisplatin 75 mg/m^2 on Day 1 Q3W, a total of 2-4 cycles,followed by surgery. |
|
| Albumin-bound paclitaxel+cisplatin+radiotherapy | Active Comparator | Participants receive albumin-bound paclitaxel 125 mg/m^2 on Day 1, 8 Q3W, and cisplatin 75 mg/m^2 on Day 1 Q3W, a total of 2 cycles combined with radiotherapy(40Gy/2Gy),followed by surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 inhibitor | Drug | PD-1 Inhibitor 200mg D1 Q3W |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic complete response (pCR) rate | Within 14 working days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | Within 14 working days after surgery | |
| Overall Survival (OS) | OS is defined as the time from randomization until death from any cause. | Up to 8 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuoyan Liu | Contact | +86 13805088816 | shuoyanliu2010@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Shuoyan Liu | Fujian Cancer Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer Hospital | Recruiting | Fuzhou | Fujian | China |
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| Albumin-Bound Paclitaxel |
| Drug |
125 mg/m^2 D1/D8 Q3W |
|
| Cisplatin | Drug | 75 mg/m^2 D1 Q3W |
|
| Radiation | Radiation | 40Gy/2.0Gy |
|
| Disease Free Survival (DFS) | The time from the first day of the date of surgery to local or distant recurrence, or death caused by any cause, whichever occurs first; | Up to 8 years |
| the Second Hospital of Longyan | Not yet recruiting | Longyan | Fujian | China |
|
| the First Hospital of Putian City | Not yet recruiting | Putian | Fujian | China |
|
| Fujian Medical University 2nd Affiliated Hospital | Not yet recruiting | Quanzhou | Fujian | China |
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| Quanzhou First Hospital | Not yet recruiting | Quanzhou | Fujian | China |
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| the First Affiliated Hospital of Xiamen University | Not yet recruiting | Xiamen | Fujian | China |
|
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D000077277 | Esophageal Squamous Cell Carcinoma |
| 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 |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
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| ID | Term |
|---|---|
| D000082082 | Immune Checkpoint Inhibitors |
| D000068196 | Albumin-Bound Paclitaxel |
| D002945 | Cisplatin |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D055585 | Physical Phenomena |
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