CRISEC: Chemoradiotherapy Plus Immunotherapy Followed by Surgery for Esophageal Cancer
Study Details
Study Description
Brief Summary
Neoadjuvant chemoradiotherapy is recommended as standard therapy for resectable esophageal cancer. The recurrence rate after surgery following neoadjuvant chemoradiotherapy is about 35%. Whether achieving pathological complete response after neoadjuvant chemoradiotherapy is significantly associated with recurrence after surgery. It is reported that immunotherapy combined with chemotherapy improved survival compared with chemotherapy alone in first line therapy of advanced esophageal cancer. We hypothesize that the addition of immunotherapy to neoadjuvant chemoradiotherapy is helpful to improving pathologic complete response and survival.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Tislelizumab arm Radiotherapy: PTV 41.4Gy in 23 Fractions,5 days per week; Chemotherapy: Paclitaxel (Albumin bound) (100mg per square meter of body-surface area weekly) and Caboplatin (area under the curve of 2 mg per milliliter per minute weekly) for 5 weeks, concurrent with radiotherapy; Immunotherapy: Tislelizumab (200mg per 3 weeks) |
Drug: Tislelizumab
neoadjuvant immunotherapy
|
Outcome Measures
Primary Outcome Measures
- Pathologic complete response rate [1 month after surgery]
Pathologic complete response rate
Secondary Outcome Measures
- Disease free survival [2 years after first medication of Tislelizumab]
Disease free survival
- overall survival [2 years after first medication of Tislelizumab]
overall survival
Eligibility Criteria
Criteria
Main Inclusion Criteria:
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Pathologically diagnosed as esophageal squamous cell carcinoma
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Initially diagnosed as thoracic esophageal cancer
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resectable or potantially resectable
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II-IVA according to AJCC 8th edition;
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KPS≥70
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Adequate organ function
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Union Hospital | Wuhan | Hubei | China | 430022 |
Sponsors and Collaborators
- Wuhan Union Hospital, China
- BeiGene
Investigators
- Principal Investigator: Kunyu Yang, MD, Wuhan Union Hospital, China
Study Documents (Full-Text)
None provided.More Information
Publications
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- Rice TW, Chen LQ, Hofstetter WL, Smithers BM, Rusch VW, Wijnhoven BP, Chen KL, Davies AR, D'Journo XB, Kesler KA, Luketich JD, Ferguson MK, Räsänen JV, van Hillegersberg R, Fang W, Durand L, Cecconello I, Allum WH, Cerfolio RJ, Pera M, Griffin SM, Burger R, Liu JF, Allen MS, Law S, Watson TJ, Darling GE, Scott WJ, Duranceau A, Denlinger CE, Schipper PH, Lerut TE, Orringer MB, Ishwaran H, Apperson-Hansen C, DiPaola LM, Semple ME, Blackstone EH. Worldwide Esophageal Cancer Collaboration: pathologic staging data. Dis Esophagus. 2016 Oct;29(7):724-733. doi: 10.1111/dote.12520.
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