Advanced Colorectal CancerNCT04835324
Regorafenib Treatment Patterns and Survival Outcomes in Advanced Colorectal Cancer: A Real-world Study
An observational study of Advanced Colorectal Cancer, run by Chinese Academy of Medical Sciences at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Colorectal Cancer
- How many people
- 650 participants
- Where
- 2 sitesChina
- Study dates
- 1 Oct 2020to 1 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: About 1000 patients in this observational study were recruited in 10 Chinese medical centers since July 2017 to October 2020.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Cancer Hospital,Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College
Beijing, 100021
About this study
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
- Advanced Colorectal Cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month Overall Survival rate
6 months OS rate of patients who received regorafenib treatment.
Measured: 6 month
1 year Overall Survival rate
1 year OS rate of patients who received regorafenib treatment.
Measured: 1 year
overall survival
overall survival of patients who received regorafenib treatment.
Measured: 1 year
Secondary outcomes (3)
objective response rate
Investigator assessed according to RECIST v1.1
Measured: 1 year
Disease control rate
Investigator assessed according to RECIST v1.1
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Oct 2020
- Primary completion1 Feb 2022
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Aiping Zhou, Chinese Academy of Medical Sciences
- Investigators
- Yunbo Zhao, Study chair, Beijing HospitalLiangjun Zhu, Study chair, Jiangsu Cancer Institute & HospitalZimin Liu, Study chair, The Affiliated Hospital of Qingdao UniversityWei Bai, Study chair, Shanxi Province Cancer HospitalAimin Zang, Study chair, Affiliated Hospital of Hebei UniversityBo Liu, Study chair, Shandong Cancer Hospital and InstituteHong Zong, Study chair, The First Affiliated Hospital of Zhengzhou UniversityShengmian Li, Study chair, The fourth hospital of Hebei medical university and hebei cancer hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835324
- Sponsor's protocol ID
- ChineseAcademyMedicalSciences
- Status last verified
- Mar 2022
- First submitted
- 28 Mar 2021
- Last updated
- 11 Mar 2022
- Results posted
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38166647
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regorafenib Treatment Patterns and Survival Outcomes in Advanced Colorectal Cancer: A Real-world Study
- ClinicalTrials.gov ID
- NCT04835324
- Acronym / sponsor ID
- ChineseAcademyMedicalSciences
- Conditions
- Advanced Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- 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
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- About 1000 patients in this observational study were recruited in 10 Chinese medical centers since July 2017 to October 2020.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
6-month Overall Survival rate
Time frame: 6 month
6 months OS rate of patients who received regorafenib treatment.
1 year Overall Survival rate
Time frame: 1 year
1 year OS rate of patients who received regorafenib treatment.
overall survival
Time frame: 1 year
overall survival of patients who received regorafenib treatment.
3 secondary outcomes
objective response rate
Time frame: 1 year
Disease control rate
Time frame: 1 year
Incidence of Adverse Events (AEs)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Derived from this study: PubMed 38166647Qu 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.
Related trials for Advanced Colorectal Cancer
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Not yet recruitingObservational study
Multidimensional Study Designed to Develop a Methodological Framework Based on MRI Data to Predict Pathological Complete Response (pCR) in Patients With Locally Advanced Rectal Cancer After Neoadjuvant Treatment
Rectal Cancer, Chemoradiotherapy
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yunbo Zhao study chair
Beijing Hospital
Liangjun Zhu study chair
Jiangsu Cancer Institute & Hospital
Zimin Liu study chair
The Affiliated Hospital of Qingdao University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Colorectal Cancer, run by Chinese Academy of Medical Sciences at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month Overall Survival rate (time frame: 6 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04835324, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.