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This is a single-arm,open-label study to evaluate the efficacy and safety of tislelizumab plus chemotherapy for conversion therapy of patients with locally nonresectable ESCC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tislelizumab plus Chemotherapy | Experimental | In the single experimental arm, patients with locally nonresectable disease were subjected to receive neoadjuvant tislelizumab (200mg) plus chemotherapy (FP regimen) for conversion therapy. If conversion therapy succeeds, patients would proceed to surgery and adjuvant therapy. Otherwise, if patients were still not resectable after the conversion therapy, they will be treated by tislelizumab plus chemotherapy with or without palliative radiotherapy . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | The 1st to 3rd doses were administered concurrently with FP regimen chemotherapy, 200 mg Tislelizumab each, on D1, D22 and D43 by intravenous infusion. In patients with successful conversion, one dose of 200 mg was administered 21 days after surgery in concurrent with the 4th to 6th cycles of 5-Fu, then 6 cycles of 200 mg Tislelizumab as adjuvant therapy; in patients with failed conversion, chemotherapy combined with tislelizumab were administered, with or without radiation therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of translational treatment AE | Translational treatment-related AEs resulted in rates of surgery that were more than 30 days late or inoperable than originally planned | up to 2 years |
| MPR | The proportion of patients whose primary tumor cell residual was less than 10% in the total number of patients enrolled after transformation therapy | up to 2 years |
| pCR | Pathological complete response refers to that no tumor component or a small amount of carcinoma in situ component can be found on the horizontal line of pathological section after systemic treatment and surgical resection of the lesion. | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | The proportion of patients who completed R0 resection through 3 cycles of immunotherapy combined with chemotherapy in the total enrolled population.R0 finger resection margin under microscope was negative. | up to 2 years |
| Disease-free Survival,DFS |
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Inclusion Criteria:
Exclusion Criteria:
Patients meeting any of the following criteria are not eligible for inclusion:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tongpeng Xu, PhD | Contact | 18915594572 | tongpeng_xu_njmu@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial People's Hospital | Recruiting | Nanjing | Jiangsu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39179863 | Derived | Xu T, Bai J, Zhao K, Chen X, Wang S, Zhu S, Sun C, Zhao C, Wang T, Zhu L, Hu M, Pang F, Zhang J, Wang W, Shu Y, Li F, Zhou Y. Induction Therapy of Tislelizumab Combined with Cisplatin and 5-Fluorouracil and Subsequent Conversion Surgery in Patients with Unresectable Advanced Esophageal Squamous Cell Carcinoma: A Phase 2, Single Center Study. Ann Surg Oncol. 2024 Dec;31(13):9321-9331. doi: 10.1245/s10434-024-16033-x. Epub 2024 Aug 23. |
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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 |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D005472 | Fluorouracil |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
| 5-FU | Drug | A FP regimen with 5-Fu 850mg/m^2 d1-4 + cis-platinum 850mg/m^2 d1-4 was used, on D1, D22 and D43 infused intravenously. 3 cycles of 5-Fu 850mg/m^2 d1-4 adjuvant chemotherapy were started at 21 days after surgery in patients with a successful conversion. In patients with failed conversion, chemotherapy combined with tislelizumab were administered, with or without radiation therapy. |
|
| cis Platinum | Drug | A FP regimen with 5-Fu 850mg/m^2 d1-4 + cis-platinum 850mg/m^2 d1-4 was used, on D1, D22 and D43 infused intravenously. In patients with failed conversion, chemotherapy combined with tislelizumab were administered, with or without radiation therapy. |
|
The time from randomization to disease recurrence or death due to disease progression |
| up to 2 years |
| 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 |
| D006571 |
| Heterocyclic Compounds |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |