A Real-World Study Evaluating the Effectiveness and Safety of Immune Checkpoint Inhibitors and Chemotherapy for Advanced Esophageal Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Esophageal Cancer
- Sponsor
- Guangdong Provincial People's Hospital
- Enrollment
- 155
- Locations
- 2
- Primary Endpoint
- Safety as measured by number of participants with Grade 3 and 4 adverse events
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The role of preoperative chemotherapy as standard therapy is well-established for advanced esophageal cancer. Immunotherapeutic agents such as Immune checkpoint inhibitors has been shown to improve objective response rate in solid tumors. However, there is a paucity of data regarding the efficacy and safety of preoperative immunotherapy plus chemotherapy in esophageal cancer patients in real-world practice. This study set out to investigate whether the combination of preoperative chemotherapy and immune checkpoint inhibitors is beneficial to improve the objective response rate as well as the pathological complete response rate in a real-world scenario.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pathologically diagnosed as esophageal squamous cell carcinoma
- •Adequate organ function
- •No distant metastasis
- •The diseases could be resected or potentially resectable after immunochemotherapy assessed by a thoracic oncologist
Exclusion Criteria
- •incomplete medical record which affects statistical analysis
- •have participated in previous interventional clinical trials
- •other situations evaluated by investigators not meet the enrollment
Outcomes
Primary Outcomes
Safety as measured by number of participants with Grade 3 and 4 adverse events
Time Frame: Up to 12 weeks
Number of Grade 3 and 4 adverse events as defined by CTCAE v5.0
Objective Response Rate (ORR)
Time Frame: Up to 24 weeks
Objective Response Rate
Feasibility of immunochemotherapy defined as at least 80% of the patients completed all planned courses
Time Frame: Up to 36 weeks
The feasibility of immunochemotherapy was defined as at least 80% of the patients completed all planned courses.
Secondary Outcomes
- Major pathological response(Three to five working days after surgery)
- R0 resection rate(Three to five working days after surgery)
- Pathologic complete response rate (pCR)(Three to five working days after surgery)
- Overall survival(from the date of diagnosis to the date of death, assessed up to 100 months)
- Event-free survival(from the date of treatment initiation to the date of first progression (local recurrence of tumor or distant metastasis) or death from any cause, assessed up to 100 months)