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This study includes patients with resectable esophageal squamous cell carcinoma who will undergo local radiotherapy (PTV: 1.5Gy Bid, for 5 days), followed by neoadjuvant treatment with Serplulimab combined with cisplatin and paclitaxel for three cycles. Afterward, they will undergo surgery. Postoperatively, researchers will select adjuvant treatment plans based on the patients' conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | PTV:1.5Gy Bid,5 days Serplulimab (300mg) + Albumin-bound paclitaxel + Cisplatin/Carboplatin, Q3W, 3cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serplulimab | Drug | Serplulimab (300mg) + Albumin-bound paclitaxel + Cisplatin/Carboplatin, Q3W, 3cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| pCR(Pathological Complete Response) | Definition of pathology complete response is "no cancer cell, including lympho nodes" | within 14 working days after operation |
| Measure | Description | Time Frame |
|---|---|---|
| MPR(Major Pathological Remission rate) | The residual tumor after neoadjuvant treatment ≤ 10% residual tumor lesion in surgical specimen compared to baseline. | within 14 working days after operation |
| ORR(Objective Response Rate) |
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Inclusion Criteria:
Patients with histologically confirmed squamous cell carcinoma of the esophagus (ESCC) staged as cT1-2N+M0 and cT3NanyM0 (AJCC 8th edition);
Aged between 18-75 years;
ECOG performance status score of 0-1;
The following laboratory tests confirm that the bone marrow, liver and kidney functions meet the requirements for study participation
No severe concomitant diseases with a life expectancy of less than 5 years;
Voluntary and able to comply with the study protocol during the study period;
Provide written informed consent prior to entering the study, and the patient has been informed that they can withdraw from the study at any time without any loss.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheng Dr.Zhang, MD. PhD. | Contact | 0086-139714426 | tonydppx@hotmail.com | |
| Rui Dr. Zhou, MD. PhD. | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
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The Objective Response Rate (ORR) will be defined as the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR) (RECIST V1.1)
| 3-4 weeks after the last cycle of neoadjuvant treatment |
| Rate of R0 resection | Measure the rate of R0 resection with all margins microscopically clear. | within 14 working days after operation |
| EFS (Events Free Survival) | The time from the start of treatment until any of the following events occur: any disease progression that prevents surgery, postoperative disease progression or recurrence, or death due to any cause | The date from the beginning of randomization to the date of first record. 5 years EFS |
| Safety assessment | Safety and tolerability based on incidence of treatment-emergent adverse events as assessed by CTCAE | From the first dose of study drug up to 30 days after last dose of any component of treatment or surgery or the initiation of subsequent anticancer therapy, whichever occurred first. Up to approximately 9 months. |
| 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 |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| 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 |
| D056831 | Coordination Complexes |
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