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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Esophageal Cancer
• Intervention / Treatment: Drug: Camrelizumab

• Study Type: Observational
• Enrollment (Anticipated): 1030

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

unresectable locally advanced/recurrent or metastatic esophageal cancer

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
unresectable locally advanced/recurrent or metastatic esophageal cancer	Drug: Camrelizumab; The recommended formulation of Camrelizumab is 200 mg every time, or 3 mg/Kg according to body weight, intravenously infused.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events of Camrelizumab	especially Occurrence of ≥Grade 3 immune-related AEs	an expected average of 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events of Camrelizumab	including other occasional or rare AEs	an expected average of 24 months
Overall Survival	Duration from the date of initial treatment to the date of death due to any cause	an expected average of 24 months
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
Objective Response Rate (ORR)	Proportion of objective complete response and partial response patients	an expected average of 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Peking University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2026

Study Registration Dates

• First Submitted: October 10, 2020
• First Submitted That Met QC Criteria: November 1, 2020
• First Posted (ACTUAL): November 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 1, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: LION-EC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No