A Real-world Study Evaluating the Usage of Camrelizumab in Chinese Patients With Advanced Esophageal Cancer
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
1 other identifier
observational
1,030
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2020
CompletedFirst Posted
Study publicly available on registry
November 4, 2020
CompletedStudy Start
First participant enrolled
December 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedNovember 4, 2020
November 1, 2020
3 years
October 10, 2020
November 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events of Camrelizumab
especially Occurrence of ≥Grade 3 immune-related AEs
an expected average of 24 months
Secondary Outcomes (4)
Adverse events of Camrelizumab
an expected average of 24 months
Overall Survival
an expected average of 24 months
Progression-free Survival (PFS)
an expected average of 24 months
Objective Response Rate (ORR)
an expected average of 24 months
Other Outcomes (1)
Correlations between biomarkers and clinical activity
an expected average of 24 months
Study Arms (1)
unresectable locally advanced/recurrent or metastatic esophageal cancer
Interventions
The recommended formulation of Camrelizumab is 200 mg every time, or 3 mg/Kg according to body weight, intravenously infused.
Eligibility Criteria
unresectable locally advanced/recurrent or metastatic esophageal cancer
You may qualify if:
- 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);
- Age ≥ 18 years old;
- The investigator determines that the patient can receive Camrelizumab as a single agent or combination therapy.
You may not qualify if:
- Evidence suggests that the patient is pregnant or breastfeeding;
- Other drug blinded clinical trials are currently underway;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 10, 2020
First Posted
November 4, 2020
Study Start
December 1, 2020
Primary Completion
December 1, 2023
Study Completion (Estimated)
December 1, 2026
Last Updated
November 4, 2020
Record last verified: 2020-11