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This is a Phase III, multicenter, open-label, randomized controlled trial. The study aims to compare organ preservation versus esophagectomy in patients with locally advanced, resectable thoracic esophageal squamous cell carcinoma (ESCC) who achieve a complete or partial clinical response (cCR/cPR) following neoadjuvant immunochemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Organ Preservation with Radical Chemoradiotherapy | Experimental | Patients achieving clinical complete or partial response (cCR/cPR) after neoadjuvant immunochemotherapy will receive definitive chemoradiotherapy for organ preservation. Radiotherapy (50.4 Gy/28 fractions, IMRT) with concurrent weekly chemotherapy (e.g., paclitaxel + cisplatin). Patients with ycCR after chemoradiotherapy will enter observation. Patients with residual disease will undergo salvage esophagectomy. |
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| Immediate Esophagectomy | Experimental | Patients achieving cCR/cPR after neoadjuvant immunochemotherapy will undergo immediate radical esophagectomy (McKeown or Ivor-Lewis procedure) with 2-field or 3-field lymph node dissection. Postoperative immunotherapy (up to 8 cycles) may be administered based on pathological findings (ypT≥1 or N+). |
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| Non-Responder Surgery | Active Comparator | Patients with stable disease (cSD) or progressive disease (cPD) after neoadjuvant immunochemotherapy will undergo immediate radical esophagectomy, which is the standard of care for this subgroup. Postoperative treatment is determined by pathological findings. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy | Drug | This is the standard induction therapy administered to all enrolled patients. It consists of the PD-1 inhibitor Toripalimab combined with Nab-paclitaxel |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year Event-Free Survival (EFS) Rate | Event-Free Survival is defined as the time from randomization (for responders) or from the start of neoadjuvant therapy (for the overall population) until the occurrence of any of the following events: Local recurrence of esophageal cancer. Distant metastasis. Death from any cause | 3 years after randomization/treatment initiation |
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Inclusion Criteria:
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Based on the study protocol, the Inclusion Criteria translated into English are as follows:
Age 18-75 years, any sex.
ECOG Performance Status 0-1.
Histologically confirmed, previously untreated thoracic esophageal squamous cell carcinoma (ESCC).
Clinical stage cT2N0M0, T3N0-2M0 (AJCC 8th Edition), assessed as resectable with a potential for R0 resection by endoscopic ultrasound (EUS), PET-CT, and contrast-enhanced CT. Patients with cervical lymph node metastasis may also be included if deemed suitable for three-field lymphadenectomy by a multidisciplinary team assessment.
Adequate bone marrow, hepatic, and renal function:
Signed written informed consent form (ICF).
Exclusion Criteria:
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Based on the study protocol, the Exclusion Criteria you listed translate into English as follows:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Zheng, M.D./Ph.D | Contact | (+86)0371-65587610 | hnszlyylixiang@163.com | |
| Song | Contact | (+86)0371-65587610 | hnszlyylixiang@163.com |
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| Radiation with Concurrent Chemotherapy | Combination Product | Chemotherapy administered concurrently with radiotherapy |
|
| Radical Esophagectomy | Procedure | Standard surgical procedure with lymph node dissection |
|
| 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 |
|---|---|
| C000656314 | toripalimab |
| C520255 | 130-nm albumin-bound paclitaxel |
| D017671 | Platinum Compounds |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D007287 | Inorganic Chemicals |
| D055585 | Physical Phenomena |
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