Esophageal Cancer
Conditions
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.
Interventions
DRUGCamrelizumab
The recommended formulation of Camrelizumab is 200 mg every time, or 3 mg/Kg according to body weight, intravenously infused.
Sponsors
Peking University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Sign informed consent and voluntarily participate in this study. 2. 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; 3. Age ≥ 18 years old; 4. The investigator determines that the patient can receive Camrelizumab as a single agent or combination therapy.
Exclusion criteria
1. Evidence suggests that the patient is pregnant or breastfeeding; 2. Other drug blinded clinical trials are currently underway; 3. Other situations that are not suitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events of Camrelizumab | an expected average of 24 months | especially Occurrence of ≥Grade 3 immune-related AEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events of Camrelizumab | an expected average of 24 months | including other occasional or rare AEs |
| Overall Survival | an expected average of 24 months | Duration from the date of initial treatment to the date of death due to any cause |
| Progression-free Survival (PFS) | an expected average of 24 months | A duration from the date of initial treatment to radiographic disease progression or death of any cause |
| Objective Response Rate (ORR) | an expected average of 24 months | Proportion of objective complete response and partial response patients |
Other
| Measure | Time frame | Description |
|---|---|---|
| Correlations between biomarkers and clinical activity | an expected average of 24 months | tumor biopsies are collected before start of treatment, for assessing the relationship between different biomarkers (e.g. PD-L1 expression) with different camrelizumab-based regimens |
Countries
China
Outcome results
None listed