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

Guangdong Provincial People's Hospital155 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

155

Conditions

Esophageal Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Outcomes

Primary Outcomes

Objective Response Rate (ORR)

Objective Response Rate

Time frame: Up to 24 weeks

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

Time frame: Up to 12 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.

Time frame: Up to 36 weeks

Secondary Outcomes

Pathologic complete response rate (pCR)

The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery

Time frame: Three to five working days after surgery

R0 resection rate

The R0 resection rate of esophagectomy

Time frame: Three to five working days after surgery

Overall survival

Overall survival rate

Time frame: from the date of diagnosis to the date of death, assessed up to 100 months

Event-free survival

EFS

Time frame: 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

Major pathological response

≤10% residual viable tumor follow NAIC

Time frame: Three to five working days after surgery