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

NCT ID: NCT04835324

Last Updated: 2022-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

650 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-10-01

Brief Summary

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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

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Conditions

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Advanced Colorectal Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Hospital

OTHER_GOV

Sponsor Role collaborator

Jiangsu Cancer Institute & Hospital

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role collaborator

Shanxi Province Cancer Hospital

OTHER

Sponsor Role collaborator

Affiliated Hospital of Hebei University

OTHER

Sponsor Role collaborator

Shandong Cancer Hospital and Institute

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role collaborator

First Hospital of China Medical University

OTHER

Sponsor Role collaborator

Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Aiping Zhou

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yunbo Zhao

Role: STUDY_CHAIR

Beijing Hospital

Liangjun Zhu

Role: STUDY_CHAIR

Jiangsu Cancer Institute & Hospital

Zimin Liu

Role: STUDY_CHAIR

The Affiliated Hospital of Qingdao University

Wei Bai

Role: STUDY_CHAIR

Shaanxi Provincial Cancer Hospital

Aimin Zang

Role: STUDY_CHAIR

Affiliated Hospital of Hebei University

Bo Liu

Role: STUDY_CHAIR

Shandong Cancer Hospital and Institute

Hong Zong

Role: STUDY_CHAIR

The First Affiliated Hospital of Zhengzhou University

Shengmian Li

Role: STUDY_CHAIR

The fourth hospital of Hebei medical university and hebei cancer hospital

Xiujuan Qu

Role: STUDY_CHAIR

First Hospital of China Medical University

Aiping Zhou

Role: PRINCIPAL_INVESTIGATOR

Cancer Hospital Chinese Academy of Medical Science

Locations

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Cancer Hospital,Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status

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

Beijing, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 38166647 (View on PubMed)

Other Identifiers

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ChineseAcademyMedicalSciences

Identifier Type: -

Identifier Source: org_study_id

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