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

Esophageal Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04616040
• Other study ID #: LION-EC
• Status: Not yet recruiting
• Start date: December 1, 2020
• Est. completion date: December 1, 2026

Study information

• Verified date: November 2020
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1030
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• Camrelizumab
The recommended formulation of Camrelizumab is 200 mg every time, or 3 mg/Kg according to body weight, intravenously infused.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlations between biomarkers and clinical activity	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	an expected average of 24 months
Primary	Adverse events of Camrelizumab	especially Occurrence of =Grade 3 immune-related AEs	an expected average of 24 months
Secondary	Adverse events of Camrelizumab	including other occasional or rare AEs	an expected average of 24 months
Secondary	Overall Survival	Duration from the date of initial treatment to the date of death due to any cause	an expected average of 24 months
Secondary	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
Secondary	Objective Response Rate (ORR)	Proportion of objective complete response and partial response patients	an expected average of 24 months