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

Advanced Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04835324
• Other study ID #: ChineseAcademyMedicalSciences
• Status: Active, not recruiting
• Start date: October 1, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: March 2022
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 650
• Est. completion date: October 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
China	Cancer Hospital,Chinese Academy of Medical Sciences	Beijing	Beijing
China	National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College	Beijing

Sponsors (10)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences	Affiliated Hospital of Hebei University, Beijing Hospital, First Hospital of China Medical University, Hebei Medical University Fourth Hospital, Jiangsu Cancer Institute & Hospital, Shandong Cancer Hospital and Institute, Shanxi Province Cancer Hospital, The Affiliated Hospital of Qingdao University, The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-month Overall Survival rate	6 months OS rate of patients who received regorafenib treatment.	6 month
Primary	1 year Overall Survival rate	1 year OS rate of patients who received regorafenib treatment.	1 year
Primary	overall survival	overall survival of patients who received regorafenib treatment.	1 year
Secondary	objective response rate	Investigator assessed according to RECIST v1.1	1 year
Secondary	Disease control rate	Investigator assessed according to RECIST v1.1	1 year
Secondary	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.	1 year