A Real-world Study Evaluating the Usage of Camrelizumab in Chinese Patients With Advanced Esophageal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Camrelizumab.
- Who it may be relevant to
- Registry conditions: Esophageal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
- Drug Camrelizumab
The recommended formulation of Camrelizumab is 200 mg every time, or 3 mg/Kg according to body weight, intravenously infused.
Primary outcome measures
- Adverse events of Camrelizumab [Time frame: an expected average of 24 months]
Secondary outcome measures (4)
- Adverse events of Camrelizumab [Time frame: an expected average of 24 months]
- Overall Survival [Time frame: an expected average of 24 months]
- Progression-free Survival (PFS) [Time frame: an expected average of 24 months]
- Objective Response Rate (ORR) [Time frame: an expected average of 24 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
China · 1 center
- Beijing Cancer Hospital — Beijing
Identifiers
NCT: NCT04616040 · LION-EC