Esophageal Cancer
Conditions
Keywords
esophageal cancer, real-world study, immunotherapy, chemotherapy
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.
Interventions
None listed
Sponsors
The People's Hospital of Gaozhou
The General Hospital of Southern Theater Command
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
Guangdong Provincial People's Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Up to 24 weeks | Objective Response Rate |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Overall survival | from the date of diagnosis to the date of death, assessed up to 100 months | Overall survival rate |
Countries
China
Outcome results
None listed