Colorectal CancerPhase 2NCT05451719
Fruquintinib Plus Capecitabine Versus Capecitabine as Maintenance Therapy for Metastatic Colorectal Cancer After First-line Chemotherapy
A Phase 2 study testing Fruquintinib Plus Capecitabine and Capecitabine in people with Colorectal Cancer and Colorectal Cancer Stage IV, run by Fudan University.
Trial summary
This is an open-label, multicenter, randomized phase 2 study evaluating the efficacy and safety of fruquintinib plus capecitabine versus capecitabine as maintenance therapy for metastatic colorectal cancer after first-line treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer, Colorectal Cancer Stage IV
- What is being tested?
- Fruquintinib Plus Capecitabine and Capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to Jul 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old at the time of signing the informed consent;
- Patients who have been histologically or cytologically confirmed adenocarcinoma of the colon or rectum (stage IV);
- Patients who have achieved disease control (including CR/PR and SD) after 6 cycles of first-line standard chemotherapy and are still unresectable;
- At least one measurable metastatic lesion(s) as defined by RECIST version 1.1;
- ECOG performance status of 0-2;
- Life expectancy≥3 months;
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- Adequate organ and bone marrow functions: Neutrophils >1.5×109/L, platelets >100×109/L, and hemoglobin >9 g/dL; Total bilirubin <1.5×upper limit of normal (ULN); aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and/or alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) <3×ULN (<5×ULN in case of liver metastases); Creatinine clearance (calculated according to Cockcroft and Gault) ≥60 mL/min; Serum creatinine < 1.5×ULN;
- 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;
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
Who cannot join
- Had a surgical procedure within 4 weeks prior to treatment; Received radiation therapy, radiofrequency therapy, chemotherapy, immunotherapy or molecular targeted therapy, or other investigational drugs within 2 weeks prior to treatment;
- Prior treatment with anti-vascular small-molecule targeted drugs, such as Fruquintinib or Regorafenib;
- A history of severe intolerance to capecitabine or 5-FU (i.e. grade 4 toxicity of one of the drugs; Grade 3-4 toxicity of other concomitant drugs is not excluded);
- Symptomatic brain or meningeal metastases (except for patients with BMS who have received local radiotherapy or surgery for more than 6 months and whose disease is stable).
- Patients with hypertension that cannot be well controlled by antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);
- Have obvious clinical bleeding symptoms or obvious bleeding tendency within 3 months before treatment (bleeding > 30 mL within 3 months, hematemesis, black feces, hematozoia), hemoptysis (fresh blood > 5 mL within 4 weeks), etc. Treatment for venous/venous thrombosis events within the previous 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; Long-term anticoagulant therapy with warfarin or heparin, or long-term antiplatelet therapy (aspirin ≥300 mg/day or clopidogrel ≥75 mg/day);
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- Active heart disease, including myocardial infarction, severe/unstable angina, 6 months prior to treatment. Echocardiography examination left ventricular ejection fraction < 50%, arrhythmia control is not good;
- The patient has had other malignant tumors within 3 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- Allergy to the study drug or any of its excipients;
- Severe infection with active or uncontrolled infection;
- Any other disease, with clinical significance of metabolic abnormalities, abnormal physical examination or laboratory abnormalities, according to researchers, there is reason to suspect the patient has not suitable for the use of study drugs of a disease or condition (such as have a seizure and require treatment), or will affect the interpretation of results, or to make patients in high-risk situations;
- Urine routine showed urine protein ≥2+, and 24-hour urine protein level >1.0g.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Fruquintinib Plus Capecitabine Versus Capecitabine as Maintenance Treatment for Metastatic Colorectal Cancer After First-line Chemotherapy: A Phase II, Randomized, Controlled Study
This is an open-label, multicenter, randomized phase 2 study evaluating the efficacy and safety of fruquintinib plus capecitabine versus capecitabine as maintenance therapy for metastatic colorectal cancer after first-line treatment. Patients who have already achieved disease control (including CR/PR and SD) after ≥6 cycles of standard first-line induction treatment, and are still unresectable would be assigned into 2 maintenance treatment groups by randomization in a 1:1 ratio to receive fruquintinib + capecitabine or capecitabine. All patients will be treated until progressive disease, death from any cause, unacceptable toxicity or informed consent withdrawal.
- Conditions
- Colorectal Cancer, Colorectal Cancer Stage IV
- Being tested
- Fruquintinib Plus Capecitabine, Capecitabine
- Keywords
- Colorectal Cancer
- 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 CapecitabineDrug
Fruquintinib at the dose determined in phase safety lead-in, orally once daily, on d1-21, given every 4 weeks (Q4W). Capecitabine at the dose 850mg/m2, orally twice daily, d1-7 and d15-21, given every 4 weeks (Q4W)
CapecitabineDrug
Capecitabine at the dose 850mg/m2, orally twice daily, d1-7 and d15-21, given every 4 weeks (Q4W)
| Study group | Role | What they receive |
|---|---|---|
| Fruquintinib Plus Capecitabine | Experimental | Maintenance therapy with Fruquintinib Plus Capecitabine Receives: Drug: Fruquintinib Plus Capecitabine |
| Capecitabine | Active comparator | Maintenance therapy with Capecitabine Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
A duration from the date of initial treatment to disease progression or death of any cause
Measured: From Baseline to primary completion date, about 24 months
Secondary outcomes (4)
Objective response rate (ORR, RECIST 1.1)
The incidence of confirmed complete response or partial response
Measured: From Baseline to primary completion date, about 24 months
Disease Control Rate (DCR, RECIST 1.1)
The incidence of complete response, partial response and stable disease
Measured: From Baseline to primary completion date, about 24 months
Overall survival (OS)
From the time of enrollment to death caused by any reason
Measured: From Baseline to primary completion date, about 24 months
The incidence of adverse events
The safety and tolerability of Surufatinib will be evaluated based on adverse events data.
Measured: From Baseline to primary completion date, about 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study startJul 2022 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionJul 2025 (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 Fudan 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junjie Peng, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451719
- Sponsor's protocol ID
- HMPL-013-FLAG-C116
- Status last verified
- Jul 2022
- First submitted
- 2 Jul 2022
- Last updated
- 12 Jul 2022
- Results posted
- No
- 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 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Fruquintinib Plus Capecitabine Versus Capecitabine as Maintenance Treatment for Metastatic Colorectal Cancer After First-line Chemotherapy: A Phase II, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT05451719
- Acronym / sponsor ID
- HMPL-013-FLAG-C116
- Conditions
- Colorectal Cancer, Colorectal Cancer Stage IV
- Keywords
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 11 Jul 2022 (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 an open-label, multicenter, randomized phase 2 study evaluating the efficacy and safety of fruquintinib plus capecitabine versus capecitabine as maintenance therapy for metastatic colorectal cancer after first-line treatment. Patients who have already achieved disease control (including CR/PR and SD) after ≥6 cycles of standard first-line induction treatment, and are still unresectable would be assigned into 2 maintenance treatment groups by randomization in a 1:1 ratio to receive fruquintinib + capecitabine or capecitabine. All patients will be treated until progressive disease, death from any cause, unacceptable toxicity or informed consent withdrawal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fruquintinib Plus Capecitabine | Experimental | Drug: Fruquintinib Plus CapecitabineMaintenance therapy with Fruquintinib Plus Capecitabine |
| Capecitabine | Active comparator | Drug: CapecitabineMaintenance therapy with Capecitabine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥18 years old at the time of signing the informed consent;
- Patients who have been histologically or cytologically confirmed adenocarcinoma of the colon or rectum (stage IV);
- Patients who have achieved disease control (including CR/PR and SD) after 6 cycles of first-line standard chemotherapy and are still unresectable;
- At least one measurable metastatic lesion(s) as defined by RECIST version 1.1;
- ECOG performance status of 0-2;
Key exclusion criteria (12 listed)
- Had a surgical procedure within 4 weeks prior to treatment; Received radiation therapy, radiofrequency therapy, chemotherapy, immunotherapy or molecular targeted therapy, or other investigational drugs within 2 weeks prior to treatment;
- Prior treatment with anti-vascular small-molecule targeted drugs, such as Fruquintinib or Regorafenib;
- A history of severe intolerance to capecitabine or 5-FU (i.e. grade 4 toxicity of one of the drugs; Grade 3-4 toxicity of other concomitant drugs is not excluded);
- Symptomatic brain or meningeal metastases (except for patients with BMS who have received local radiotherapy or surgery for more than 6 months and whose disease is stable).
- Patients with hypertension that cannot be well controlled by antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);
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 CapecitabineFruquintinib at the dose determined in phase safety lead-in, orally once daily, on d1-21, given every 4 weeks (Q4W). Capecitabine at the dose 850mg/m2, orally twice daily, d1-7 and d15-21, given every 4 weeks (Q4W) | Drug | Fruquintinib Plus Capecitabine |
| CapecitabineCapecitabine at the dose 850mg/m2, orally twice daily, d1-7 and d15-21, given every 4 weeks (Q4W) | Drug | Capecitabine |
Primary outcome
Progression-free Survival (PFS)
Time frame: From Baseline to primary completion date, about 24 months
A duration from the date of initial treatment to disease progression or death of any cause
4 secondary outcomes
Objective response rate (ORR, RECIST 1.1)
Time frame: From Baseline to primary completion date, about 24 months
Disease Control Rate (DCR, RECIST 1.1)
Time frame: From Baseline to primary completion date, about 24 months
Overall survival (OS)
Time frame: From Baseline to primary completion date, about 24 months
The incidence of adverse events
Time frame: From Baseline to primary completion date, about 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fruquintinib Plus Capecitabine and Capecitabine in people with Colorectal Cancer and Colorectal Cancer Stage IV, run by Fudan University.
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 9 inclusion and 12 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 12 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junjie Peng, MD, PhD (86-18017317122, pengjj67@hotmail.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 Baseline to primary completion date, about 24 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 12 Jul 2022.