A Real-world Study Evaluating the Usage of Camrelizumab in Chinese Patients With Advanced Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
The trial is a multi-center, open, observational registration study, which aims to evaluate the safety and efficacy of Camrelizumab (anti-PD-1 antibody) in the treatment of Chinese patients with advanced esophageal cancer in the real world.

Official Title
-----------------
A Non-interventional Registration Study Evaluating the Usage of Camrelizumab in the Treatment of Unresectable Locally Advanced/Recurrent or Metastatic Chinese Patients With Esophageal Cancer

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Drug: Camrelizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sign informed consent and voluntarily participate in this study. Unresectable locally advanced/recurring or distant metastatic esophageal cancer patients confirmed by histology or cytology (AJCC 8th edition); Unresectable locally advanced patients who are unable or unable to receive radical treatment (including radical radio chemotherapy or radical radiotherapy, etc.) may be considered for inclusion; Patients who progress or relapse after neoadjuvant or adjuvant therapy may also be considered for inclusion; Age ≥ 18 years old; The investigator determines that the patient can receive Camrelizumab as a single agent or combination therapy. Exclusion Criteria: Evidence suggests that the patient is pregnant or breastfeeding; Other drug blinded clinical trials are currently underway; Other situations that are not suitable for inclusion in this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| unresectable locally advanced/recurrent or metastatic esophageal cancer<br> | Drug: Camrelizumab<br>* The recommended formulation of Camrelizumab is 200 mg every time, or 3 mg/Kg according to body weight, intravenously infused.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events of Camrelizumab | especially Occurrence of ≥Grade 3 immune-related AEs | an expected average of 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events of Camrelizumab | including other occasional or rare AEs | an expected average of 24 months | 
| Overall Survival | Duration from the date of initial treatment to the date of death due to any cause | an expected average of 24 months | 
| Progression-free Survival (PFS) | A duration from the date of initial treatment to radiographic disease progression or death of any cause | an expected average of 24 months | 
| Objective Response Rate (ORR) | Proportion of objective complete response and partial response patients | an expected average of 24 months |