Chemotherapy, Esophageal Squamous Cell Carcinoma, Immunotherapy
Conditions
Keywords
Advanced Esophageal Carcinoma, Immunochemotherapy, Trajectory analysis, Blood cell counts
Brief summary
Conduct a retrospective and prospective study to confirm the association between blood cells counts and the efficacy and safety in immunochemotherapy in patients with advanced esophageal cancer.
Detailed description
Studies have already demonstrated the feasibility of prognostic role of protein biomarkers change during the treatment trajectory of patients in several carcinoma,However, no study focused on the value of trajectory analysis of blood cells counts of Immunochemotherapy in patients with advanced esophageal cancer. The investigators plan to analyze the dynamic change of blood cells counts longitudinally from preoperation to long term follow-up in advanced esophageal cancer and predict the efficacy and safety of immunochemotherapy.
Interventions
None listed
Sponsors
Guangdong Provincial People's Hospital
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Pathologically confirmed esophageal squamous cell carcinoma * Potentially resectable esophageal squamous cell carcinoma at first diagnosis (cT1-4a N1-2 M0, cT3-T4a N0M0) * Treatment-naive * Expected life span \> 6 months * Aged 18 - 75 years old * Adequate organ functions * Performance Status (PS) 0-2 * Participants are fully informed about the whole study and are willing to sign the informed consent
Exclusion criteria
* Previous history of thoracic surgery or radiation * Cervical or multi-origin esophageal cancer * Known or suspected experimental drug allergy * Pregnant or lactating women * Esophagomediastinal fistula * Peripheral neuropathy * Previous cancer history other than esophageal cancer * Severe organ function deterioration that can not tolerate neoadjuvant therapy * Previous autoimmune diseases * diabetic history \> 10 years * interstitial pulmonary disease, non-infectious pulmonitis * Active type B hepatitis * Any other conditions that may affect patients' safety and compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival and disease-free survival. | From the date of diagnosis to the date of death, assessed up to 100 months | Overall survival rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic complete response rate | Three to five working days after surgery | The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery |
| Objective Response Rate (ORR) | Up to 24 weeks | Immune-modified Response Evaluation Criteria In SolidTumors (iRECIST) criteria defined complete response and partial response |
| Major pathological response | Three to five working days after surgery | ess than 10% residual viable tumor follow neoadjuvant therapy |
| 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 | Event-free survival (EFS) |
Countries
China
Contacts
Primary Contactguibin Qiao, MD
Outcome results
None listed