Regorafenib Treatment Patterns and Survival Outcomes in Advanced Colorectal Cancer: A Real-world Study

March 9, 2022 updated by: Aiping Zhou, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

This is a multi-center, retrospective, real-world study. The purpose of this study is to observe the effectiveness and safety of regorafenib in Chinese advanced colorectal cancer patients.

The main observational goals include overall survival(OS), 6 month OS rate, 1 year OS rate, and treatment time failure (TTF), other study goals include objective response rate( ORR)、Disease control rate（DCR）and adverse event(AE) of regorafenib.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

650

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100021
        • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
    • Beijing
      • Beijing, Beijing, China, 100021
        • Cancer Hospital,Chinese Academy of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

About 1000 patients in this observational study were recruited in 10 Chinese medical centers since July 2017 to October 2020.

Description

Inclusion Criteria:

  1. Patients with colorectal cancer confirmed by pathological tissue or cytology；
  2. The pathological type of colorectal tumor was adenocarcinoma；
  3. Patients with recurrent or metastatic, unresectable advanced colorectal cancer；
  4. Patients who received regorafenib at least one period treatment.

Exclusion Criteria:

  1. Patients participating in other interventional clinical studies while taking regorafenib;
  2. Patients with other malignant tumors within 5 years before regorafenib treatment, except for cured cervical carcinoma in situ, skin squamous cell carcinoma or basal cell carcinoma, early papillary thyroid carcinoma, etc.;
  3. The investigator deems that there are other factors that are not suitable for patients who participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-month Overall Survival rate
Time Frame: 6 month
6 months OS rate of patients who received regorafenib treatment.
6 month
1 year Overall Survival rate
Time Frame: 1 year
1 year OS rate of patients who received regorafenib treatment.
1 year
overall survival
Time Frame: 1 year
overall survival of patients who received regorafenib treatment.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response rate
Time Frame: 1 year
Investigator assessed according to RECIST v1.1
1 year
Disease control rate
Time Frame: 1 year
Investigator assessed according to RECIST v1.1
1 year
Incidence of Adverse Events (AEs)
Time Frame: 1 year
Number of patients with AE, treatment-related AE (TRAE), AE of special interest (AESI), serious adverse event (SAE) assessed by CTCAE v5.0.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborators

Shanxi Province Cancer Hospital
The Affiliated Hospital of Qingdao University
Beijing Hospital
Shandong Cancer Hospital and Institute
The First Affiliated Hospital of Zhengzhou University
Affiliated Hospital of Hebei University
Jiangsu Cancer Institute & Hospital
Hebei Medical University Fourth Hospital
First Hospital of China Medical University

Investigators

  • Study Chair: Yunbo Zhao, Beijing Hospital
  • Study Chair: Zimin Liu, The Affiliated Hospital of Qingdao University
  • Study Chair: Wei Bai, Shanxi Provincial Cancer Hospital
  • Study Chair: Aimin Zang, Affiliated Hospital of Hebei University
  • Study Chair: Bo Liu, Shandong Cancer Hospital and Institute
  • Study Chair: Hong Zong, The First Affiliated Hospital of Zhengzhou University
  • Study Chair: Shengmian Li, The Fourth Hospital of Hebei Medical University and Hebei Cancer Hospital
  • Study Chair: Xiujuan Qu, First Hospital of China Medical University
  • Principal Investigator: Aiping Zhou, Cancer Hospital Chinese Academy of Medical Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2020

Primary Completion (ACTUAL)

February 1, 2022

Study Completion (ANTICIPATED)

October 1, 2022

Study Registration Dates

First Submitted

March 28, 2021

First Submitted That Met QC Criteria

April 6, 2021

First Posted (ACTUAL)

April 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 11, 2022

Last Update Submitted That Met QC Criteria

March 9, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChineseAcademyMedicalSciences

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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