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Clinical Trial NCT04776590 (CRISEC) for Esophagus Cancer, Neoadjuvant Therapy is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Chemoradiotherapy Plus Immunotherapy Followed by Surgery for Esophageal Cancer (CRISEC) Phase 2 30 Immunotherapy

Active, not recruiting
Clinical Trial NCT04776590 (CRISEC) is designed to study Treatment for Esophagus Cancer, Neoadjuvant Therapy. It is a Phase 2 interventional study that is active, not recruiting, having started on January 28, 2021, with plans to enroll 30 participants. Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, it is expected to complete by December 15, 2024. The latest data from ClinicalTrials.gov was last updated on April 12, 2024.
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 w...Show More
Official Title

Neoadjuvant Chemoradiotherapy Plus Tislelizumab Followed by Surgery for Thoracic Esophageal Squamous Cell Cancer: A Prospective, Single Arm, Pilot Study

Conditions
Esophagus CancerNeoadjuvant Therapy
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • CRISEC
  • ESC001
NCT ID Number
NCT04776590
Start Date (Actual)
2021-01-28
Last Update Posted
2024-04-12
Completion Date (Estimated)
2024-12-15
Enrollment (Estimated)
30
Study Type
Interventional
PHASE
Phase 2
Status
Active, not recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalTislelizumab 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)
Tislelizumab
neoadjuvant immunotherapy
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Pathologic complete response rate
Pathologic complete response rate
1 day on which pathologic results is reported
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Disease free survival
Disease free survival
2 years after surgery
overall survival
overall survival
2 years after enrollment
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Pathologically diagnosed as esophageal squamous cell carcinoma
  • Initially diagnosed as thoracic esophageal cancer
  • resectable or potantially resectable
  • II-IVA according to AJCC 8th edition；
  • KPS≥70
  • Adequate organ function
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology logoUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
BeiGene logoBeiGene
Study Responsible Party
kunyu yang, Principal Investigator, Director of Department of Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
No contact data.
1 Study Locations in 1 Countries

Hubei

Union Hospital, Wuhan, Hubei, 430022, China