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NCT Number: NCT04616040

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

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Sign informed consent and voluntarily participate in this study.
  • 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;
  • Age ≥ 18 years old;
  • The investigator determines that the patient can receive Camrelizumab as a single agent or combination therapy.

Exclusion criteria

  • Evidence suggests that the patient is pregnant or breastfeeding;
  • Other drug blinded clinical trials are currently underway;
  • Other situations that are not suitable for inclusion in this study.

Treatment and study plan

Camrelizumab

Drug

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

Primary outcomes

  1. Adverse events of Camrelizumab

    Time frame: an expected average of 24 months

    especially Occurrence of ≥Grade 3 immune-related AEs

Secondary outcomes

  1. Adverse events of Camrelizumab

    Time frame: an expected average of 24 months

    including other occasional or rare AEs

  2. Overall Survival

    Time frame: an expected average of 24 months

    Duration from the date of initial treatment to the date of death due to any cause

  3. Progression-free Survival (PFS)

    Time frame: an expected average of 24 months

    A duration from the date of initial treatment to radiographic disease progression or death of any cause

  4. Objective Response Rate (ORR)

    Time frame: an expected average of 24 months

    Proportion of objective complete response and partial response patients

Other outcomes

  1. Correlations between biomarkers and clinical activity

    Time frame: an expected average of 24 months

    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

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2026
First posted
Nov 4, 2020
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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