NCT04835324

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
650

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

March 11, 2022

Status Verified

March 1, 2022

Enrollment Period

1.3 years

First QC Date

March 28, 2021

Last Update Submit

March 9, 2022

Conditions

Advanced Colorectal Cancer

Outcome Measures

Primary Outcomes (3)

  • 6-month Overall Survival rate

    6 months OS rate of patients who received regorafenib treatment.

    6 month

  • 1 year Overall Survival rate

    1 year OS rate of patients who received regorafenib treatment.

    1 year

  • overall survival

    overall survival of patients who received regorafenib treatment.

    1 year

Secondary Outcomes (3)

  • objective response rate

    1 year

  • Disease control rate

    1 year

  • Incidence of Adverse Events (AEs)

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patients participating in other interventional clinical studies while taking regorafenib;
  • 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.;
  • The investigator deems that there are other factors that are not suitable for patients who participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cancer Hospital,Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College

Beijing, 100021, China

Location

Related Publications (1)

  • Qu W, Liu Z, Chen X, Liu B, Zhao Y, Yan H, Qu X, Li S, Zang A, Sun Y, Zhu L, Zhou A. Regorafenib monotherapy or combined with an immune-checkpoint inhibitor as later-line treatment for metastatic colorectal cancer: a multicenter, real-world retrospective study in China. BMC Cancer. 2024 Jan 2;24(1):22. doi: 10.1186/s12885-023-11700-w.

    PMID: 38166647DERIVED

Study Officials

  • Yunbo Zhao

    Beijing Hospital

    STUDY CHAIR

  • Liangjun Zhu

    Jiangsu Cancer Institute & 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

    STUDY CHAIR

  • Aiping Zhou

    Cancer Hospital Chinese Academy of Medical Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

March 28, 2021

First Posted

April 8, 2021

Study Start

October 1, 2020

Primary Completion

February 1, 2022

Study Completion

October 1, 2022

Last Updated

March 11, 2022

Record last verified: 2022-03

Locations

CN(2)