Metastatic Colorectal CancerPhase 2NCT05004441
Fruquintinib Combined With mFOLFOX6/FOLFIRI in First-line Treatment for Metastatic Colorectal Cancer
A Phase 2 study testing Fruquintinib Combined With mFOLFOX6/FOLFIRI in people with Metastatic Colorectal Cancer, run by Zhou Fuxiang at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Fruquintinib Combined With mFOLFOX6/FOLFIRI as the first-line treatment of 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 Combined With mFOLFOX6/FOLFIRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2021to 30 Nov 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
- Age ≥ 18 years, ≤75 years
- Histologically confirmed unresectable or metastatic stage colorectal cancer
- Known RAS activating mutation/wild type and BRAF wild type;
- Patients have not received systematic treatment for unresectable or metastatic colorectal cancer (those who have received adjuvant or neoadjuvant chemotherapy with one regimen and relapsed more than 12 months after the end of chemotherapy can be enrolled);
- At least one measurable disease according to RECIST 1.1 guidelines for solid tumors；
- BMI≥18；
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- ECOG 0-1
- Life expectancy > 12 weeks
- Patients must have adequate organ function
- Women of childbearing age must have a negative pregnancy test within the first day of the study, and contraceptive methods should be taken during the study until 6 months after the last administration;
- Informed consent has been signed.
Who cannot join
- Have received other systemic anti-tumor therapies within 2 weeks before recruited(eg.chemotherapy or radiotherapy, immunotherapy, biological or hormonal therapy, or any VEGFR inhibitor treatment);
- Known BRAF activating mutation
- systolic blood pressure > 140mmHg or diastolic blood pressure > 90mmHg regardless of any antihypertensive drugs; Or patients need more than two antihypertensive drugs;
- Clinically significant electrolyte abnormality;
- Proteinuria ≥ 2+ (1.0g/24hr);
- Patients have untreated central nervous system metastasis;
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- Patients have not recovered from all toxicities associated with prior anti-tumor therapy ,to acceptable baseline status, or a National Cancer Institute Common Terminology Criteria for Adverse Events(NCI CTCAE v5.0) Grade of 0 or 1, except for alopecia and oxaliplatin induced neurotoxicity ≤ 2 , and the previous surgery did not recover completely;
- Have received other systemic anti-tumor therapies within 4 weeks before recruited;
- Clinical uncontrolled active infections, such as acute pneumonia and active hepatitis B / C (previous history of hepatitis B virus infection, whether drug controlled or not, HBV DNA ≥ 104) × Copy number or ≥ 2000 IU / ml);
- Dysphagia or known malabsorption of drugs;
- Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in GI;
- Have evidence or history of bleeding tendency within 2 months after enrollment, the researcher assessed that moderate or severe bleeding tendency was not suitable for enrollment;
- Stroke (including transient ischemic attack) occurred within 12 months before admission;
- Patients had other malignant tumors in the past 5 years or at the same time (except for the cured skin basal cell carcinoma and cervical carcinoma in situ);
- Pregnant or lactating women;
- Allergic to fruquintinib；
- History of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or organ transplantation;
- Patients with acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before admission; Or a history of arterial thrombosis or deep venous thrombosis;
- There are concomitant diseases (such as severe hypertension, diabetes, thyroid disease, active infection, etc.) that seriously endanger the safety of patients or affect the completion of the study, or any laboratory abnormalities that are not suitable for participating in the clinical trial according to the judgment of the researcher,
- Serious psychological or mental disorders that may affect the compliance study;
- Participating in other drug clinical trials within 4 weeks before recruited.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fruquintinib Combined With mFOLFOX6/FOLFIRI in First-line Treatment for Metastatic Colorectal Cancer：HCCSC C02 Trial
The purpose of this study is to evaluate the efficacy and safety of Fruquintinib Combined With mFOLFOX6/FOLFIRI as the first-line treatment of Metastatic Colorectal Cancer
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Fruquintinib Combined With mFOLFOX6/FOLFIRI
- 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 Combined With mFOLFOX6/FOLFIRIDrug
Fruquintinib (3mg) will be given p.o. daily
| Study group | Role | What they receive |
|---|---|---|
| First-line treatment | Experimental | First-line treatment: Fruquintinib Combined With mFOLFOX6/FOLFIRI for eight cycles.
Maintenance treatment: Fruquintinib and Capecitabine Receives: Drug: Fruquintinib Combined With mFOLFOX6/FOLFIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate (ORR)
Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
Measured: 36 months
Secondary outcomes (4)
disease control rate (DCR)
DCR was defined as the percentage of participants who have a confirmed complete response（CR） or partial response（PR） or stable disease（SD） per RECIST 1.1 as assessed by investigator
Measured: 36 months
Progression-Free Survival (PFS)
PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator
Measured: 36 months
overall survival (OS)
OS is the time from enrollment to death due to any cause.
Measured: 36 months
adverse events (AE)
overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use.
Measured: 36 months
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 start30 Jul 2021
- Primary completion30 May 2023
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhou Fuxiang
- Sponsor type
- University, hospital or other
- Collaborators
- Hubei Cancer Hospital, Henan Cancer Hospital, Xiangya Hospital of Central South University, Huangshi Central Hospital
- Responsible party
- Sponsor-investigator, Zhou Fuxiang, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004441
- Sponsor's protocol ID
- HCCSC C02
- Status last verified
- Sep 2026
- First submitted
- 6 Aug 2021
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fruquintinib Combined With mFOLFOX6/FOLFIRI in First-line Treatment for Metastatic Colorectal Cancer：HCCSC C02 Trial
- ClinicalTrials.gov ID
- NCT05004441
- Acronym / sponsor ID
- HCCSC C02
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Zhou FuxiangUniversity, hospital or other
- Collaborators
- Hubei Cancer Hospital, Henan Cancer Hospital, Xiangya Hospital of Central South University, Huangshi Central Hospital
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 Nov 2024 (actual)
- 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.
The purpose of this study is to evaluate the efficacy and safety of Fruquintinib Combined With mFOLFOX6/FOLFIRI as the first-line treatment of Metastatic Colorectal Cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First-line treatment | Experimental | Drug: Fruquintinib Combined With mFOLFOX6/FOLFIRIFirst-line treatment: Fruquintinib Combined With mFOLFOX6/FOLFIRI for eight cycles. Maintenance treatment: Fruquintinib and Capecitabine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years, ≤75 years
- Histologically confirmed unresectable or metastatic stage colorectal cancer
- Known RAS activating mutation/wild type and BRAF wild type;
- Patients have not received systematic treatment for unresectable or metastatic colorectal cancer (those who have received adjuvant or neoadjuvant chemotherapy with one regimen and relapsed more than 12 months after the end of chemotherapy can be enrolled);
- At least one measurable disease according to RECIST 1.1 guidelines for solid tumors；
Key exclusion criteria (21 listed)
- Have received other systemic anti-tumor therapies within 2 weeks before recruited(eg.chemotherapy or radiotherapy, immunotherapy, biological or hormonal therapy, or any VEGFR inhibitor treatment);
- Known BRAF activating mutation
- systolic blood pressure > 140mmHg or diastolic blood pressure > 90mmHg regardless of any antihypertensive drugs; Or patients need more than two antihypertensive drugs;
- Clinically significant electrolyte abnormality;
- Proteinuria ≥ 2+ (1.0g/24hr);
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 Combined With mFOLFOX6/FOLFIRIFruquintinib (3mg) will be given p.o. daily | Drug | First-line treatment |
Primary outcome
objective response rate (ORR)
Time frame: 36 months
Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
4 secondary outcomes
disease control rate (DCR)
Time frame: 36 months
Progression-Free Survival (PFS)
Time frame: 36 months
overall survival (OS)
Time frame: 36 months
adverse events (AE)
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Combined With mFOLFOX6/FOLFIRI in people with Metastatic Colorectal Cancer, run by Zhou Fuxiang 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 11 inclusion and 21 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: finished, as of the sponsor's last update on 17 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
objective response rate (ORR) (time frame: 36 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 17 Sep 2026.