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

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

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.

Study Overview

• Status: Completed
• Conditions: Esophageal Cancer

• Study Type: Observational
• Enrollment (Actual): 155

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial People's Hospital
    • Shantou, Guangdong, China, 515031
      • Shantou Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed as potentially resectable (including initially-unresectable) esophageal squamous cell carcinoma via pathological specimen, KPS ≥ 80, has adequate organ function and no distant metastasis are included in the study

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Objective Response Rate (ORR)	Objective Response Rate	Up to 24 weeks
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival rate	from the date of diagnosis to the date of death, assessed up to 100 months
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
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
R0 resection rate	The R0 resection rate of esophagectomy	Three to five working days after surgery
Major pathological response	≤10% residual viable tumor follow NAIC	Three to five working days after surgery

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ACTUAL): October 1, 2021
• Study Completion (ACTUAL): October 31, 2021

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: March 28, 2021
• First Posted (ACTUAL): March 30, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: chemotherapy; immunotherapy; esophageal cancer; real-world study
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: RICE-retro

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No