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

• Conditions: Advanced Colorectal Cancer

• Registration Number: NCT04835324
• Lead Sponsor: Chinese Academy of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2021-03-28
• Study First Submitted QC: 2021-04-06
• Study First Posted: 2021-04-08
• Primary Completion: 2022-02-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-09
• Last Update Posted: 2022-03-11
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 650

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
objective response rate	1 year	Investigator assessed according to RECIST v1.1
Disease control rate	1 year	Investigator assessed according to RECIST v1.1
Incidence of Adverse Events (AEs)	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.

Trial Locations

Locations (2)

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, China