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

NCT ID: NCT04616040

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1030 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2026-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Esophageal Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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unresectable locally advanced/recurrent or metastatic esophageal cancer

Camrelizumab

Intervention Type DRUG

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

Interventions

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Camrelizumab

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University

OTHER

Sponsor Role lead

Responsible Party

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Shen Lin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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LION-EC

Identifier Type: -

Identifier Source: org_study_id