Metastatic Colorectal CancerPhase 2NCT05004831
Fruquintinib Combined With TAS-102 in the Treatment of Patients With Advanced Metastatic CRC
A Phase 2 study testing fruquintinib plus TAS-102 in people with Metastatic Colorectal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
This phase II study aims to explore the efficacy and safety of fruquintinib combined with TAS-102 in the third-line treatment of patients with advanced metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- fruquintinib plus TAS-102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 11 Mar 2022to Sep 2024
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 and ≤ 75 years of age;
- Histological or cytological confirmed advanced metastatic colorectal cancer;
- Refractory to at least second line standard treatment containing fluorouracil, oxaliplatin and irinotecan;
- At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan or 20mm by conventional CT scan);
- ECOG performance status of 0-1;
- Life expectancy ≥ 12 weeks;
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- No previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitor (TKI);
- Signed and dated informed consent;
- Adequate hepatic, renal, heart, and hematologic functions;
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
Who cannot join
- Pregnant or lactating women;
- Any factors that influence the usage of oral administration or any disease or condition that affects drug absorption;
- Previous treatment with TAS-102;
- Participated in clinical trials of other drugs within four weeks before enrollment;
- Received other systemic anti-tumor therapy within 4 weeks before enrollment, including chemotherapy, signal transduction inhibitors, hormone therapy and immunotherapy;
- International normalized ratio (INR) > 1.5 or partially activated prothrombin time (APTT) > 1.5 × ULN;
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- Clinically significant electrolyte abnormalities;
- Subjected with hypertension that cannot be controlled by drugs, which is specified as: systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg;
- Unrelieved toxic reactions higher than CTCAE V5.0 grade 1 caused by any previous anti-cancer treatment;
- Incomplete healing of skin wound, surgical site, traumatic site, severe mucosal ulcer or fracture;
- Conditions that may cause gastrointestinal bleeding and perforation determined by the researcher;
- History of arterial thrombosis or deep venous thrombosis within 6 months before enrollment;
- Stroke and / or transient cerebral ischemia occurred within 12 months before enrollment;
- Cardiovascular diseases with significant clinical significance;
- LVEF<50%;
- Congestive heart failure New York Heart Association (NYHA) grade > 2;
- Evidence of CNS metastasis;
- Previous treatment with VEGFR inhibition;
- Ventricular arrhythmias requiring drug treatment;
- Proteinuria ≥ 2+ (1.0g/24hr);
- Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy;
- Other malignant tumors in the past 5 years, except skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;
- Active infection that is not controlled clinically, such as acute pneumonia, active hepatitis B or hepatitis C;
- By judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the first affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
JIANJUN PENG, PhD, 86-20-87332200 ext. 8211, aidigua@hotmail.com
About this study
Official title: Phase II Study of Fruquintinib Combined With TAS-102 in the Treatment of Patients With Advanced Metastatic CRC
This phase II study aims to explore the efficacy and safety of fruquintinib combined with TAS-102 in the third-line treatment of patients with advanced metastatic colorectal cancer.
Read the detailed description
This is a prospective, single center, one-arm phase II study. A total of 54 advanced mCRC patients refractory to standard therapies will be enrolled and administered with fruquintinib (4mg/d, qd po, D1-21, Q4W) combined with TAS-102 (70mg/m2/d, bid po, D1-5, 8-12, Q4W) until intolerable toxicity, disease progression or death. Primary endpoint of this study is PFS and secondary endpoints are OS, ORR, DCR and safety.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- fruquintinib plus 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 plus TAS-102Drug
fruquintinib 4mg/d, qd po, D1-21, Q4W; TAS-102 70mg/m2/d, bid po, D1-5, 8-12, Q4W
| Study group | Role | What they receive |
|---|---|---|
| fruquintinib plus TAS-102 | Experimental | fruquintinib plus TAS-102, orally given, Q4W Receives: Drug: fruquintinib plus TAS-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-free Survival
Measured: from randomization up to progressive disease or EOT due to any cause, up to 2 years
Secondary outcomes (4)
OS
Overall Survival
Measured: from randomization until death due to any cause, assessed up to 3 years
DCR
Disease Control Rate
Measured: from randomization up to progressive disease or EOT due to any cause, up to 2 years
ORR
Objective Response Rate
Measured: from randomization up to progressive disease or EOT due to any cause, up to 2 years
Safety and tolerance
Safety and tolerance evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0
Measured: from first dose to within 30 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start11 Mar 2022
- Primary completionSep 2023 (estimated)
- Study completionSep 2024 (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 Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Jian-jun, Sun Yat-sen University
- Investigators
- Jianjun Peng, M.D., Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004831
- Sponsor's protocol ID
- HMPL-013-FLAG-C106
- Status last verified
- Aug 2022
- First submitted
- 6 Aug 2021
- Last updated
- 18 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Peng J, Li Y, Huang L, Liu J, Xiao J, Xie D, Wang W, Zhang Z, Weng C, Chai X, Li H, Jiang X, Qian Y, Zhao R, Chen S, Jiang Z, Le L, Li X, Long J, Zhang H, Chen C, Cai S. Efficacy and Safety of Fruquintinib Plus TAS-102 in Patients With Previously Treated Metastatic Colorectal Cancer: Results From a Single-Arm, Multi-Center, Phase II Study. MedComm (2020). 2026 Oct 13;7(10):e71070. doi: 10.1002/mco2.71070. eCollection 2026 Oct.
PubMed 42871678
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Fruquintinib Combined With TAS-102 in the Treatment of Patients With Advanced Metastatic CRC
- ClinicalTrials.gov ID
- NCT05004831
- Acronym / sponsor ID
- HMPL-013-FLAG-C106
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 13 Aug 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 phase II study aims to explore the efficacy and safety of fruquintinib combined with TAS-102 in the third-line treatment of patients with advanced metastatic colorectal cancer.
Detailed description
This is a prospective, single center, one-arm phase II study. A total of 54 advanced mCRC patients refractory to standard therapies will be enrolled and administered with fruquintinib (4mg/d, qd po, D1-21, Q4W) combined with TAS-102 (70mg/m2/d, bid po, D1-5, 8-12, Q4W) until intolerable toxicity, disease progression or death. Primary endpoint of this study is PFS and secondary endpoints are OS, ORR, DCR and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fruquintinib plus TAS-102 | Experimental | Drug: fruquintinib plus TAS-102fruquintinib plus TAS-102, orally given, Q4W |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥ 18 and ≤ 75 years of age;
- Histological or cytological confirmed advanced metastatic colorectal cancer;
- Refractory to at least second line standard treatment containing fluorouracil, oxaliplatin and irinotecan;
- At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan or 20mm by conventional CT scan);
- ECOG performance status of 0-1;
Key exclusion criteria (24 listed)
- Pregnant or lactating women;
- Any factors that influence the usage of oral administration or any disease or condition that affects drug absorption;
- Previous treatment with TAS-102;
- Participated in clinical trials of other drugs within four weeks before enrollment;
- Received other systemic anti-tumor therapy within 4 weeks before enrollment, including chemotherapy, signal transduction inhibitors, hormone therapy and immunotherapy;
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 plus TAS-102fruquintinib 4mg/d, qd po, D1-21, Q4W; TAS-102 70mg/m2/d, bid po, D1-5, 8-12, Q4W | Drug | fruquintinib plus TAS-102 |
Primary outcome
PFS
Time frame: from randomization up to progressive disease or EOT due to any cause, up to 2 years
Progression-free Survival
4 secondary outcomes
OS
Time frame: from randomization until death due to any cause, assessed up to 3 years
DCR
Time frame: from randomization up to progressive disease or EOT due to any cause, up to 2 years
ORR
Time frame: from randomization up to progressive disease or EOT due to any cause, up to 2 years
Safety and tolerance
Time frame: from first dose to within 30 days after the last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Derived from this study: PubMed 42871678Peng J, Li Y, Huang L, Liu J, Xiao J, Xie D, Wang W, Zhang Z, Weng C, Chai X, Li H, Jiang X, Qian Y, Zhao R, Chen S, Jiang Z, Le L, Li X, Long J, Zhang H, Chen C, Cai S. Efficacy and Safety of Fruquintinib Plus TAS-102 in Patients With Previously Treated Metastatic Colorectal Cancer: Results From a Single-Arm, Multi-Center, Phase II Study. MedComm (2020). 2026 Oct 13;7(10):e71070. doi: 10.1002/mco2.71070. eCollection 2026 Oct.
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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.
Jianjun Peng, M.D. principal investigator
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fruquintinib plus TAS-102 in people with Metastatic Colorectal Cancer, run by Sun Yat-sen University at 1 site 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 10 inclusion and 24 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 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jianjun Peng, M.D. (+8613602263939, pjianj@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: from randomization up to progressive disease or EOT due to any cause, up to 2 years). 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 NCT05004831, 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 18 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.