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

Esophageal Cancer Clinical Trial

Official title:

A Real-World Study Evaluating the Effectiveness and Safety of Immune Checkpoint Inhibitors and Chemotherapy for Advanced Esophageal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04822103
• Other study ID #: RICE-retro
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: October 31, 2021

Study information

• Verified date: March 2022
• Source: Guangdong Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: October 31, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	Shantou Central Hospital	Shantou	Guangdong

Sponsors (8)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital	Affiliated Cancer Hospital & Institute of Guangzhou Medical University, First Affiliated Hospital of Shantou University Medical College, First Affiliated Hospital, Sun Yat-Sen University, Shantou Central Hospital, Shenzhen People's Hospital, The General Hospital of Southern Theater Command, The People's Hospital of Gaozhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	Objective Response Rate	Up to 24 weeks
Primary	Safety as measured by number of participants with Grade 3 and 4 adverse events	Number of Grade 3 and 4 adverse events as defined by CTCAE v5.0	Up to 12 weeks
Primary	Feasibility of immunochemotherapy defined as at least 80% of the patients completed all planned courses	The feasibility of immunochemotherapy was defined as at least 80% of the patients completed all planned courses.	Up to 36 weeks
Secondary	Pathologic complete response rate (pCR)	The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery	Three to five working days after surgery
Secondary	R0 resection rate	The R0 resection rate of esophagectomy	Three to five working days after surgery
Secondary	Overall survival	Overall survival rate	from the date of diagnosis to the date of death, assessed up to 100 months
Secondary	Event-free survival	EFS	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
Secondary	Major pathological response	=10% residual viable tumor follow NAIC	Three to five working days after surgery