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This multicenter, prospective Phase II study investigates a response-adapted organ-preservation strategy in patients with resectable esophageal squamous cell carcinoma (ESCC). Participants will receive two cycles of induction chemoimmunotherapy with sugemalimab, nab-paclitaxel, and cisplatin. Patients who achieve a major clinical response will receive definitive radiotherapy plus sugemalimab followed by maintenance sugemalimab, while non-major responders will undergo surgery-based treatment strategies. The study aims to evaluate the efficacy and safety of this tailored treatment approach, with the primary endpoint being 2-year progression-free survival. Secondary and exploratory objectives include survival outcomes, quality of life, nutritional status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Major Response Organ Preservation Group | Experimental | Participants with a major clinical response after induction chemoimmunotherapy will receive radiotherapy plus sugemalimab followed by maintenance sugemalimab for organ preservation. |
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| Surgery Group | Active Comparator | Participants with partial response or stable disease after induction therapy will undergo surgical resection. |
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| Radiotherapy Followed by Surgery Group | Active Comparator | Participants with partial response or stable disease after induction therapy will receive radiotherapy followed by surgical resection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugemalimab and Chemotherapy | Drug | Sugemalimab 1200 mg administered intravenously every 3 weeks as induction, and maintenance immunotherapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| 2-year PFS rate | Up to 2 years after initiation of treatment |
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Inclusion Criteria:
Age 18-75 years. Histologically confirmed, previously untreated resectable esophageal squamous cell carcinoma (ESCC).
Clinical stage IB-III according to AJCC 8th edition. ECOG performance status 0-1. Adequate hematologic, hepatic, and renal function. Ability to provide written informed consent.
Exclusion Criteria:
Prior systemic therapy, radiotherapy, surgery, or immunotherapy for ESCC. Distant metastases or suspicious cervical lymph node metastases. Prior treatment with PD-1 or PD-L1 inhibitors. Active autoimmune disease requiring systemic treatment. Uncontrolled infection, including active hepatitis or HIV infection. Significant cardiovascular, pulmonary, or other serious medical conditions that may interfere with study participation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | China |
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| Nab-paclitaxel | Drug | 125 mg/m² administered intravenously on Days 1 and 8 every 3 weeks during induction therapy. |
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| Cisplatin | Drug | 75 mg/m² administered intravenously on Day 1 every 3 weeks during induction therapy. |
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| Radiation Therapy | Radiation | IMRT: PTV 41.4 Gy/23f,PGTV 49.45 Gy/23f |
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| 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 |
|---|---|
| C000723018 | sugemalimab |
| D004358 | Drug Therapy |
| C520255 | 130-nm albumin-bound paclitaxel |
| D002945 | Cisplatin |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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