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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04616040
Other study ID # LION-EC
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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