Colorectal CancerPhase 2NCT06746545
A Prospective, Open-label, Single-arm Phase II Clinical Study of Fruquintinib Combined With S-1 for the Treatment of Metastatic Colorectal Cancer.
A Phase 2 study testing Fruquintinib+S-1 in people with Colorectal Cancer, run by Fujian Cancer Hospital.
Trial summary
Exploring the efficacy and safety of fruquintinib combined with S-1 for second-line and beyond treatment in patients with advanced colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Fruquintinib+S-1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 1 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Fully understand this study and voluntarily sign the informed consent form;
- Age ≥18 years, gender not limited;
- Confirmed advanced metastatic colorectal adenocarcinoma by histopathological examination;
- Patients have previously received at least one line of standard therapy containing fluorouracil, oxaliplatin, and irinotecan, and have progressed or are intolerant.
- Each line of treatment must include one or more chemotherapy drugs for a duration of ≥1 cycle;
- Adjuvant/neoadjuvant therapy is allowed. If recurrence or metastasis occurs during or within 6 months after completion of adjuvant/neoadjuvant therapy, it is considered a failure of first-line chemotherapy for progressive disease;
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- Prior use of chemotherapy combined with cetuximab or bevacizumab in antitumor treatment regimens is allowed;
- At least one measurable lesion (RECIST 1.1 criteria);
- ECOG performance status 0-1;
- Expected survival time ≥12 weeks;
- Within 14 days before enrollment, the function of major organs must meet the following requirements (no use of any blood components and cell growth factors within 14 days before enrollment):
- Absolute neutrophil count ≥1.5×10^9/L;
- Platelet count ≥80×10^9/L;
- Hemoglobin ≥8g/dL;
- Total bilirubin <1.5 times the upper limit of normal (ULN);
- ALT and AST <2.5 times ULN (<5 times ULN for patients with liver metastasis);
- Serum creatinine ≤1 times ULN;
- Endogenous creatinine clearance rate >50ml/min;
- Women of childbearing age or men with partners who wish to have children must use effective contraceptive measures;
- Agree to provide blood samples.
Who cannot join
- Have previously received treatment with fruquintinib or other anti-VEGFR (vascular endothelial growth factor receptor) inhibitors such as apatinib, regorafenib, and anlotinib;
- Have previously received treatment with tegafur;
- Have participated in another drug clinical trial within four weeks before enrollment and received at least one dose of medication, or have received other systemic antitumor treatments, including chemotherapy, signal transduction inhibitors, hormone therapy, and immunotherapy within four weeks before enrollment;
- Patients currently have diseases or conditions that affect drug absorption, or patients are unable to orally take fruquintinib;
- Patients currently have active gastric and duodenal ulcers, ulcerative colitis, and other gastrointestinal diseases, or have active bleeding from unresected tumors, or other conditions that may cause gastrointestinal bleeding or perforation as judged by the investigator;
- Have active bleeding or bleeding tendencies;
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- Have uncontrollable malignant pleural effusion, ascites, or pericardial effusion (defined as not effectively controlled by diuretics or puncture as judged by the investigator);
- Have a history of severe cardiovascular and cerebrovascular diseases:
- Cerebral vascular accidents (except for lacunar infarction, minor cerebral ischemia, or transient cerebral ischemic attacks), myocardial infarction, unstable angina, poorly controlled arrhythmias (including QTc interval for males ≥ 450ms, females ≥ 470ms) (QTc interval calculated using the Fridericia formula) within 6 months before the first dose of the study drug;
- New York Heart Association (NYHA) heart function classification > II or left ventricular ejection fraction (LVEF) < 50%;
- Have had other malignancies in the past 5 years, except for skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;
- Have clinically uncontrolled active infections, such as acute pneumonia, active hepatitis B or C (history of hepatitis B virus infection not under drug control, HBV DNA ≥1×10^4 copies/mL or >2000 IU/mL);
- Have clinically symptomatic central nervous system metastases and/or meningeal carcinomatosis;
- Patients currently have uncontrolled hypertension with medication, defined as: systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg after taking antihypertensive drugs;
- Urinalysis indicates urinary protein ≥2+, and re-examined 24-hour urinary protein quantity >1.0g;
- Pregnant (positive pregnancy test before medication) or breastfeeding women;
- The investigator judges that there are clinically significant severe electrolyte abnormalities, or the investigator believes that the patient is unsuitable for participation in this clinical study for other reasons.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Exploring the efficacy and safety of fruquintinib combined with S-1 for second-line and beyond treatment in patients with advanced colorectal cancer.
- Conditions
- Colorectal Cancer
- Being tested
- Fruquintinib+S-1
- 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+S-1Drug
Fruquintinib: 5 mg, oral, once daily，2w/1w；Q3W S-1：40-60 mg (dosed according to body surface area), oral，2w/1w；Q3W
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Drug: Fruquintinib+S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Tumor assessment will be performed using radiography method every 6 weeks, until the occurrence of progressive disease (PD), using RECIST v 1.1
Measured: from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year
Secondary outcomes (4)
Objective response rate (ORR)
Tumor assessment will be performed using radiography method every 6 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1
Measured: from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year
Overall survival (OS)
Tumor assessment will be performed using radiography method every 6 weeks until the occurrence of progressive disease (PD).
Measured: from randomization until death due to any cause, assessed up to 3 year
Disease control rate (DCR)
Tumor assessment will be performed using radiography method every 6 weeks until the occurrence of progressive disease (PD),using RECIST v 1.1
Measured: from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year]
Safety and tolerance evaluated by incidence, severity and outcomes of AEs
Safety and tolerance will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 5.0
Measured: from first dose to 30 days post 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 posted24 Dec 2024
- Study start1 Feb 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746545
- Sponsor's protocol ID
- F+S-1-CRC
- Status last verified
- Feb 2024
- First submitted
- 11 Dec 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Single-arm Phase II Clinical Study of Fruquintinib Combined With S-1 for the Treatment of Metastatic Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT06746545
- Acronym / sponsor ID
- F+S-1-CRC
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 24 Dec 2024 (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.
Exploring the efficacy and safety of fruquintinib combined with S-1 for second-line and beyond treatment in patients with advanced 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 |
|---|---|---|
| Experimental | Experimental | Drug: Fruquintinib+S-1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Fully understand this study and voluntarily sign the informed consent form;
- Age ≥18 years, gender not limited;
- Confirmed advanced metastatic colorectal adenocarcinoma by histopathological examination;
- Patients have previously received at least one line of standard therapy containing fluorouracil, oxaliplatin, and irinotecan, and have progressed or are intolerant.
- At least one measurable lesion (RECIST 1.1 criteria);
Key exclusion criteria (17 listed)
- Have previously received treatment with fruquintinib or other anti-VEGFR (vascular endothelial growth factor receptor) inhibitors such as apatinib, regorafenib, and anlotinib;
- Have previously received treatment with tegafur;
- Have participated in another drug clinical trial within four weeks before enrollment and received at least one dose of medication, or have received other systemic antitumor treatments, including chemotherapy, signal transduction inhibitors, hormone therapy, and immunotherapy within four weeks before enrollment;
- Patients currently have diseases or conditions that affect drug absorption, or patients are unable to orally take fruquintinib;
- Patients currently have active gastric and duodenal ulcers, ulcerative colitis, and other gastrointestinal diseases, or have active bleeding from unresected tumors, or other conditions that may cause gastrointestinal bleeding or perforation as judged by the investigator;
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+S-1Fruquintinib: 5 mg, oral, once daily，2w/1w；Q3W S-1：40-60 mg (dosed according to body surface area), oral，2w/1w；Q3W | Drug | Experimental |
Primary outcome
Progression free survival (PFS)
Time frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year
Tumor assessment will be performed using radiography method every 6 weeks, until the occurrence of progressive disease (PD), using RECIST v 1.1
4 secondary outcomes
Objective response rate (ORR)
Time frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year
Overall survival (OS)
Time frame: from randomization until death due to any cause, assessed up to 3 year
Disease control rate (DCR)
Time frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year]
Safety and tolerance evaluated by incidence, severity and outcomes of AEs
Time frame: from first dose to 30 days post the last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fruquintinib+S-1 in people with Colorectal Cancer, run by Fujian Cancer Hospital.
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 20 inclusion and 17 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: opening soon, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jintian Song (13115915866, 249599337@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year). 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 24 Dec 2024.