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Tislelizumab combined with chemotherapy sequential neoadjuvant therapy for non-cCR patients after neoadjuvant chemoradiotherapy in locally advanced ESCC. And then the patients would receive surgery and adjuvant therapy according to the postoperative pathological results. It is expected that through this study, some high-risk patients could obtain better efficacy and prolong patient survival. At same time, low risk patients could avoid increasing perioperative complications and surgical risks, so that more patients could benefit from neoadjuvant treatment. The investigators aimed to explore a more accurate comprehensive treatment mode for patients with esophageal squamous cell carcinoma, and provide a certain scientific basis for the formulation of esophageal cancer diagnosis and treatment norms in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total neoadjuvant therapy | Experimental | The patients would receive neoadjuvant chemoradiotherapy treatment firstly. And then evaluated efficacy according to RECIST 1.1. If patients with cCR would receive surgery treatment after 4-6 weeks. After surgery, patients with pCR would always perform surveillance and patients with non-pCR would receive immunotherapy alone treatment. If patients evaluated as PD, they would receive new treatment regimen after MDT discussed. Other patients with PR and SD would receive 2 cycles of neoadjuvant immunochemotherapy. And then, Efficacy of immunochemotherapy would be evaluated according to RECIST 1.1. For patients suitable for surgery, surgery should be performed after 4-6 weeks of immunotherapy. After surgery, the patients with R0 resection would divided into two groups, if patients with pCR would always perform surveillance and patients with non-pCR would receive immunotherapy treatment. Other patients without R0 resection would receive new treatment regimen after MDT discussed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirelizumab | Drug | Two cycles of Tirelizumab (200mg administered as an intravenous infusion over 30 minutes per 3 weeks), D1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete pathologic response rate | Definition of complete pathologic response is "no cancer cell, including lympho nodes" which corresponds with tumor regression score 0. Definition of pathologic response is as follows. Tumor regression score Grade 0 and 1 will be defined as "responder" and 2 and 3 will be considered as "non-responders" | 3 months |
| Incidence of adverse events | Number of participants with treatment-related adverse events as assessed by Number of participants with treatment-related adverse events as assessed by treatment-related adverse events assessed by CTCAE v4.0 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Complete Remission | The clinical complete remission rate (cCR) was defined as the proportion of patients with clinically confirmed cT0 or cN0(AJCC Cancer Staging Manual,8th ed. 2017 edition ). | 3 months |
| Major Pathological Remission rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Cancer Hospital and Research Institute | Chengdu | Sichuan | 610041 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35720312 | Derived | He W, Wang C, Wu L, Wan G, Li B, Han Y, Li H, Leng X, Du K, Chen H, Wang Q, Peng L. Tislelizumab Plus Chemotherapy Sequential Neoadjuvant Therapy for Non-cCR Patients After Neoadjuvant Chemoradiotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma (ETNT): An Exploratory Study. Front Immunol. 2022 Jun 2;13:853922. doi: 10.3389/fimmu.2022.853922. eCollection 2022. |
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| Paclitaxel | Drug | Two cycles of paclitaxel (135mg/m2 administered as an intravenous infusion per 3 weeks), D1. |
|
| Carboplatin | Drug | Two cycles of carboplatin(AUC=5 administered as an intravenous infusion per 3 weeks) D1. |
|
| Neoadiuvant radiotherapy | Radiation | Simultaneous radiotherapy would be consecutively performed for 4 weeks with the total dose of 40Gy (40Gy/ 4W /20F), D1. |
|
The residual tumor after neoadjuvant treatment ≤ 10% residual tumor lesion in surgical specimen compared to baseline。
| 3 months |
| Objective Remission Rate | Objective response rate as assessed by RECISIST1.1 criteria, the percentage of subjects with CR or PR in the total number of subjects in the analysis data set during the period from the beginning of the treatment regimen to the disease progression date. | 3 months |
| Rate of R0 resection | Measure the rate of R0 resection with all margins microscopically clear. | 3 months |
| Events Free Survival | Event-free survival was defined as the time from the date of randomization to the date of the first documented non-fatal event (worsening cardiac function, hospitalization for congestive heart failure, liver function impairment, liver cirrhosis, transformation to AML, as defined in the protocol), or death, whichever occurred first. Participants who did not experience a non-fatal event as of the time of data cut-off (end of study), as well as participants who did not experience a non-fatal event and stopped study participation before the data cut-off, were censored as specified in the protocol. | Through study completion, an average of 1 year. |
| Overall Survival | Overall survival was the duration from the start of study treatment to death | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 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 |
|---|---|
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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