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

Not yet recruiting

• Conditions: Esophageal Cancer
• Interventions: Drug: Camrelizumab

• Registration Number: NCT04616040
• Lead Sponsor: Peking University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-10
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-01
• Last Update Submitted: 2020-11-01
• Study First Posted: 2020-11-04
• Last Update Posted: 2020-11-04
• Study Start: 2020-12-01
• Primary Completion: 2023-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1030

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
unresectable locally advanced/recurrent or metastatic esophageal cancer	Camrelizumab	-

Primary Outcome Measures

Name	Time	Method
Adverse events of Camrelizumab	an expected average of 24 months	especially Occurrence of ≥Grade 3 immune-related AEs

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS)	an expected average of 24 months	A duration from the date of initial treatment to radiographic disease progression or death of any cause
Objective Response Rate (ORR)	an expected average of 24 months	Proportion of objective complete response and partial response patients
Adverse events of Camrelizumab	an expected average of 24 months	including other occasional or rare AEs
Overall Survival	an expected average of 24 months	Duration from the date of initial treatment to the date of death due to any cause

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China