Clinical trial NCT04835324: Regorafenib Treatment Patterns and Survival Outcomes in Advanced Colorectal Cancer: A Real-world Study
Official title: Regorafenib Treatment Patterns and Survival Outcomes in Advanced Colorectal Cancer: A Real-world Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Advanced Colorectal Cancer
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Beijing Hospital
name: Jiangsu Cancer Institute & Hospital
name: The Affiliated Hospital of Qingdao University
name: Shanxi Province Cancer Hospital
name: Affiliated Hospital of Hebei University
name: Shandong Cancer Hospital and Institute
name: The First Affiliated Hospital of Zhengzhou University
name: Hebei Medical University Fourth Hospital
name: First Hospital of China Medical University
First posted: 2021-04-08
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 6-month Overall Survival rate
timeFrame: 6 month
measure: 1 year Overall Survival rate
timeFrame: 1 year
measure: overall survival
timeFrame: 1 year
Secondary outcomes:
measure: objective response rate
timeFrame: 1 year
measure: Disease control rate
timeFrame: 1 year
measure: Incidence of Adverse Events (AEs)
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital,Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College
Study officials:
affiliation: Beijing Hospital
name: Yunbo Zhao
role: STUDY_CHAIR
affiliation: Jiangsu Cancer Institute & Hospital
name: Liangjun Zhu
role: STUDY_CHAIR
affiliation: The Affiliated Hospital of Qingdao University
name: Zimin Liu
role: STUDY_CHAIR
affiliation: Shanxi Provincial Cancer Hospital
name: Wei Bai
role: STUDY_CHAIR
affiliation: Affiliated Hospital of Hebei University
name: Aimin Zang
role: STUDY_CHAIR
affiliation: Shandong Cancer Hospital and Institute
name: Bo Liu
role: STUDY_CHAIR
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Hong Zong
role: STUDY_CHAIR
affiliation: The fourth hospital of Hebei medical university and hebei cancer hospital
name: Shengmian Li
role: STUDY_CHAIR
affiliation: First Hospital of China Medical University
name: Xiujuan Qu
role: STUDY_CHAIR
affiliation: Cancer hospital Chinese academy of medical science
name: Aiping Zhou
role: PRINCIPAL_INVESTIGATOR
References: