FruquintinibNCT06099314
Fruquintinib in the Cross-line Treatment of Refractory mCRC
An observational study of Fruquintinib and Metastatic Colorectal Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 3 sites in China.
Trial summary
This is a real-world study. Patients with metastatic colorectal cancer who have progressed (PD) after third-line treatment with fruquintinib combined with PD-1 inhibitors will receive fruquintinib combined with TAS-102 as fourth-line therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fruquintinib, Metastatic Colorectal Cancer
- What is being tested?
- Fruquintinib+PD-1 inhibitors and Fruquintinib+TAS-102
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 36 participants
- Where
- 3 sitesChina
- Study dates
- Oct 2023to Sep 2025
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients with metastatic colorectal cancer
Who may be able to join
- -
- To be enrolled in this study, patients must meet all of the following criteria:
- Age ≥18 years, ≤75 years;
- No gender limitation;
- Patients with metastatic colorectal cancer confirmed by histopathology had previously received 2-line system therapy with fluorouracil, oxaliplatin, irinotecan, anti-VEGF, anti-EGFR (RAS and BRAF wild type) (treatment with anti-VEGF-TKI is not allowed), and had received fruquinitinib combined with PD-1 inhibitors for third-line treatment. After progression (PD) (confirmed by RECIST 1.1 ), fruquinitinib combined with TAS-102 as fourth-line therapy was received.
- Expected survival ≥12 weeks
- Must have at least one measurable lesion (RECIST1.1).
- Full organ and bone marrow function.
Who cannot join
- -
- Patients will not be admitted to the study if they meet any of the following criteria:
- Patients with contraindications to study drugs (fruquinitinib, PD-1 inhibitor, TAS-102);
- allergic to the investigational drug or any of its adjuncts;
- There are other non-investigational drugs during third-line and fourth-line treatment;
- Pregnant or lactating female subjects;
- Patients with a large number of pleural effusion or ascites requiring drainage;
- Patients considered unsuitable for inclusion in this study by the investigators.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
TONGJI Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Dongbo Liu
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
ZhenYu Lin
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430022
wenbo wang
About this study
Official title: A Real-world Study of Fruquintinib in the Cross-line Treatment of Refractory mCRC
This is a real-world study. Patients with metastatic colorectal cancer who have progressed (PD) after third-line treatment with fruquintinib combined with PD-1 inhibitors will receive fruquintinib combined with TAS-102 as fourth-line therapy. The objective of this study was to observe the efficacy and safety of cross-line（from third to fourth line）treatment with fruquinitinib.
Read the detailed description
This is a real-world study. Patients with metastatic colorectal cancer confirmed by histopathology had previously received 2-line system therapy with fluorouracil, oxaliplatin, irinotecan, anti-VEGF, anti-EGFR (RAS and BRAF wild type) (treatment with anti-VEGF-TKI is not allowed), and had received fruquinitinib combined with PD-1 inhibitors for third-line treatment. After progression (PD) (confirmed by RECIST 1.1 ), fruquinitinib combined with TAS-102 as fourth-line therapy was received. The primary endpoint was observation the overall survival (OS) of fourth-line treatment of mCRC with fruquinitinib and TAS-102. The study objective is to explore the possibility of cross-line rechallenge of fruquinitinib.
- Conditions
- Fruquintinib, Metastatic Colorectal Cancer
- Being tested
- Fruquintinib+PD-1 inhibitors, Fruquintinib+TAS-102
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruquintinib+PD-1 inhibitorsDrug
Third-line treatment with fruquintinib combined with PD-1 inhibitors. Fruquintinib: 5mg,Oral once daily,2 weeks on/1 week off,Q3W； PD-1 inhibitor：for example, Sintilimab,iv,200mg, Q3W.
Fruquintinib+TAS-102Drug
Fourth-line treatment with fruquintinib combined with TAS-102 . Fruquintinib: 3-5mg(Depending on the patient's physical condition), Oral once daily,3 weeks on/1 week off,Q4W； TAS-102:orally, 35mg/m2 twice daily (maximum dose 80mg in a single dose) for days 1-5, repeated every 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Fruquintinib Rechallenge | 1. third-line treatment with fruquintinib combined with PD-1 inhibitors
2. fourth-line treatment with fruquintinib combined with TAS-102 Receives: Drug: Fruquintinib+PD-1 inhibitors; Drug: Fruquintinib+TAS-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival 2(OS2)
Overall survival (OS) of fourth-line treatment of mCRC with fruquinitinib and TAS-102
Measured: From the date of first fruquinitinib combined with TAS-102 treatment until the date of first documented date of death from any cause , assessed up to 12 months
Secondary outcomes (3)
Objective response rate 2(ORR2, investigator based on RECIST1.1)
Objective response rate (ORR) of fourth-line treatment of mCRC with fruquinitinib and TAS-102
Measured: from received fruquinitinib combined with TAS-102 to one year
Progression-free survival 2(PFS2, investigators based on RECIST1.1)
Progression-free survival (PFS) of fourth-line treatment of mCRC with fruquinitinib and TAS-102
Measured: From the date of first fruquinitinib combined with TAS-102 treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Disease control rate 2 (DCR2, investigators based on RECIST1.1)
Disease control rate (DCR) of fourth-line treatment of mCRC with fruquinitinib and TAS-102
Measured: from received fruquinitinib combined with TAS-102 to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study startOct 2023 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FruquintinibStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenyu Lin, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Zhenyu Lin, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099314
- Sponsor's protocol ID
- HMPL-013-C2-CRC05
- Status last verified
- Oct 2023
- First submitted
- 17 Oct 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study of Fruquintinib in the Cross-line Treatment of Refractory mCRC
- ClinicalTrials.gov ID
- NCT06099314
- Acronym / sponsor ID
- HMPL-013-C2-CRC05
- Conditions
- Fruquintinib, Metastatic Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 25 Oct 2023 (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 real-world study. Patients with metastatic colorectal cancer who have progressed (PD) after third-line treatment with fruquintinib combined with PD-1 inhibitors will receive fruquintinib combined with TAS-102 as fourth-line therapy. The objective of this study was to observe the efficacy and safety of cross-line（from third to fourth line）treatment with fruquinitinib.
Detailed description
This is a real-world study. Patients with metastatic colorectal cancer confirmed by histopathology had previously received 2-line system therapy with fluorouracil, oxaliplatin, irinotecan, anti-VEGF, anti-EGFR (RAS and BRAF wild type) (treatment with anti-VEGF-TKI is not allowed), and had received fruquinitinib combined with PD-1 inhibitors for third-line treatment. After progression (PD) (confirmed by RECIST 1.1 ), fruquinitinib combined with TAS-102 as fourth-line therapy was received. The primary endpoint was observation the overall survival (OS) of fourth-line treatment of mCRC with fruquinitinib and TAS-102. The study objective is to explore the possibility of cross-line rechallenge of fruquinitinib.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fruquintinib Rechallenge | – | Drug: Fruquintinib+PD-1 inhibitors, Drug: Fruquintinib+TAS-1021. third-line treatment with fruquintinib combined with PD-1 inhibitors 2. fourth-line treatment with fruquintinib combined with TAS-102 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic colorectal cancer
Key inclusion criteria (8 listed)
- -
- Age ≥18 years, ≤75 years;
- No gender limitation;
- Patients with metastatic colorectal cancer confirmed by histopathology had previously received 2-line system therapy with fluorouracil, oxaliplatin, irinotecan, anti-VEGF, anti-EGFR (RAS and BRAF wild type) (treatment with anti-VEGF-TKI is not allowed), and had received fruquinitinib combined with PD-1 inhibitors for third-line treatment. After progression (PD) (confirmed by RECIST 1.1 ), fruquinitinib combined with TAS-102 as fourth-line therapy was received.
- Expected survival ≥12 weeks
Key exclusion criteria (8 listed)
- -
- Patients with contraindications to study drugs (fruquinitinib, PD-1 inhibitor, TAS-102);
- allergic to the investigational drug or any of its adjuncts;
- There are other non-investigational drugs during third-line and fourth-line treatment;
- Pregnant or lactating female subjects;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fruquintinib+PD-1 inhibitorsThird-line treatment with fruquintinib combined with PD-1 inhibitors. Fruquintinib: 5mg,Oral once daily,2 weeks on/1 week off,Q3W； PD-1 inhibitor：for example, Sintilimab,iv,200mg, Q3W. | Drug | Fruquintinib Rechallenge |
| Fruquintinib+TAS-102Fourth-line treatment with fruquintinib combined with TAS-102 . Fruquintinib: 3-5mg(Depending on the patient's physical condition), Oral once daily,3 weeks on/1 week off,Q4W； TAS-102:orally, 35mg/m2 twice daily (maximum dose 80mg in a single dose) for days 1-5, repeated every 14 days. | Drug | Fruquintinib Rechallenge |
Primary outcome
Overall survival 2(OS2)
Time frame: From the date of first fruquinitinib combined with TAS-102 treatment until the date of first documented date of death from any cause , assessed up to 12 months
Overall survival (OS) of fourth-line treatment of mCRC with fruquinitinib and TAS-102
3 secondary outcomes
Objective response rate 2(ORR2, investigator based on RECIST1.1)
Time frame: from received fruquinitinib combined with TAS-102 to one year
Progression-free survival 2(PFS2, investigators based on RECIST1.1)
Time frame: From the date of first fruquinitinib combined with TAS-102 treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Disease control rate 2 (DCR2, investigators based on RECIST1.1)
Time frame: from received fruquinitinib combined with TAS-102 to one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
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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.
Zhenyu Lin principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fruquintinib and Metastatic Colorectal Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 3 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 8 inclusion and 8 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 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Contact Zhenyu Lin (15827130393, whxhlzy@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival 2(OS2) (time frame: From the date of first fruquinitinib combined with TAS-102 treatment until the date of first documented date of death from any cause , assessed up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Oct 2023.