Status unknownNCT04835324Updated Mar 11, 2022

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

An observational study in Advanced Colorectal Cancer, sponsored by Chinese Academy of Medical Sciences. Status unknown at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-11.

Sponsored by Chinese Academy of Medical Sciences · Observational

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Active, not recruiting — may be out of date.

Study type: Observational
Model: Case-only
Time perspective: Retrospective
Enrollment: 650
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Advanced Colorectal Cancer

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Colorectal Neoplasms 5,599

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 650 is above the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

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Lead sponsor

Chinese Academy of Medical Sciences is the lead sponsor of 235 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
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.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Observational model: Case-only
Time perspective: Retrospective
Enrollment: 650 participants (actual)
Patient registry: No

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

2 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04835324
Lead sponsor: Chinese Academy of Medical Sciences
Collaborators: Beijing Hospital, Jiangsu Cancer Institute & Hospital, The Affiliated Hospital of Qingdao University, Shanxi Province Cancer Hospital, Affiliated Hospital of Hebei University, Shandong Cancer Hospital and Institute, The First Affiliated Hospital of Zhengzhou University, Hebei Medical University Fourth Hospital, First Hospital of China Medical University
Responsible party: Aiping Zhou (Chief Physician, Chinese Academy of Medical Sciences) — Principal investigator
First posted: Apr 8, 2021
Start date: Oct 1, 2020
Primary completion: Feb 1, 2022
Completion: Oct 1, 2022 (estimated)
Last update: Mar 11, 2022

Study contacts

Yunbo Zhao

study chair · Beijing Hospital

Liangjun Zhu

study chair · Jiangsu Cancer Institute & Hospital

Zimin Liu

study chair · The Affiliated Hospital of Qingdao University

Wei Bai

study chair · Shanxi Provincial Cancer Hospital

Aimin Zang

study chair · Affiliated Hospital of Hebei University

Bo Liu

study chair · Shandong Cancer Hospital and Institute

Hong Zong

study chair · The First Affiliated Hospital of Zhengzhou University

Shengmian Li

study chair · The fourth hospital of Hebei medical university and hebei cancer hospital

Xiujuan Qu

study chair · First Hospital of China Medical University

Aiping Zhou

principal investigator · Cancer hospital Chinese academy of medical science

Oversight

FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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