A Real-World Study of Immune Checkpoint Inhibitors and Chemotherapy for Advanced Esophageal Cancer

Completed

• Conditions: Esophageal Cancer

• Registration Number: NCT04822103
• Lead Sponsor: Guangdong Provincial People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-03-28
• Study First Posted: 2021-03-30
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

• Pathologically diagnosed as esophageal squamous cell carcinoma
• KPS≥80
• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety as measured by number of participants with Grade 3 and 4 adverse events	Up to 12 weeks	Number of Grade 3 and 4 adverse events as defined by CTCAE v5.0
Objective Response Rate (ORR)	Up to 24 weeks	Objective Response Rate
Feasibility of immunochemotherapy defined as at least 80% of the patients completed all planned courses	Up to 36 weeks	The feasibility of immunochemotherapy was defined as at least 80% of the patients completed all planned courses.

Secondary Outcome Measures

Name	Time	Method
Major pathological response	Three to five working days after surgery	≤10% residual viable tumor follow NAIC
R0 resection rate	Three to five working days after surgery	The R0 resection rate of esophagectomy
Pathologic complete response rate (pCR)	Three to five working days after surgery	The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery
Overall survival	from the date of diagnosis to the date of death, assessed up to 100 months	Overall survival rate
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	EFS

Trial Locations

Locations (2)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China

Shantou Central Hospital; 🇨🇳 Shantou, Guangdong, China