FruquintinibNCT06169202
A Study of Fruquintinib in Combination With Irinotecan and Capecitabine for the Second-line Treatment of Patients
An observational study of Fruquintinib and Irinotecan, run by China Medical University, China at 1 site in China.
Trial summary
This is a real-world observational study of fruquintinib in combination with irinotecan and capecitabine for the second-line treatment of patients with advanced colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fruquintinib, Irinotecan, Capecitabine
- What is being tested?
- fruquintinib, Irinotecan and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to Jun 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
- No healthy volunteers
- Adult, Older adult
Study population: Male or female patients between the ages of 18-75 years
Who may be able to join
- Subjects voluntarily enrolled in the study and signed an informed consent form, were compliant and cooperated with follow-up visits;
- Patients with metastatic colorectal adenocarcinoma confirmed by pathology or histology;
- Patients with second-line metastatic colorectal adenocarcinoma who have failed prior standard first-line treatment (recurrence within 6 months of the end of adjuvant chemotherapy is considered first-line treatment failure);
- Tumor tissue testing at the primary or metastatic site allows enrollment in second-line therapy regardless of whether the KRAS, NRAS, or BRAF genes are wild-type or mutant, and regardless of microsatellite status as MSS/ pMMR or MSI-H/dMMR. For MSI-H/dMMR patients, first-line treatment was similarly allowed for enrollment if immunotherapy was used in the second line;
- Age: 18-75 (inclusive of 18 and 75), male or female;
- ECOG score: 0-1;
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- Expected survival ≥ 3 months;
- At least one measurable lesion (based on RECIST 1.1 criteria);
- Patients must undergo UGT1A1 genetic testing;
- Major organs and bone marrow function were essentially normal (no blood components or cell growth factors had been used in the 14 days prior to enrollment):
- 1)Blood count: leukocytes ≥ 3.5 x 109 /L, neutrophils ≥ 1.5 x 109 /L, platelets ≥ 100 x 109 /L, hemoglobin ≥ 90 g/L; 2)International normalized ratio (INR) ≤ 1.5 x upper limit of normal (ULN) and activated partial thromboplastin time (APTT) ≤ 1.5 x ULN; 3)Liver function: total bilirubin ≤ 1.5 x ULN; ALT/AST/ALP ≤ 2.5 x ULN in the absence of liver metastases; ALT/AST/ALP ≤ 5 x ULN in the presence of liver metastases; 4)Renal function: serum creatinine ≤ 1.5 x ULN and creatinine clearance (CCr) ≥ 60 mL/min (see Appendix); 5)Normal cardiac function with left ventricular ejection fraction (LVEF ) ≥50% by 2D cardiac ultrasound; 11. Male or female patients of childbearing potential will voluntarily use an effective method of contraception, e.g., double-barrier contraception, condoms, oral or injectable contraceptives, intrauterine devices, etc., for the duration of the study and for 6 months after the last study dose. All female patients will be considered of childbearing potential unless the female patient is naturally menopausal, has undergone artificial menopause or sterilization (e.g., hysterectomy, bilateral adnexectomy, or radiation ovarian irradiation, etc.), unless the female patient has a serum or urinalysis that shows no pregnancy within the 7 days prior to the study, and must be a non-lactating patient.
Who cannot join
- Patients who are allergic to furaquintinib, irinotecan, and capecitabine;
- Received anti-angiogenic small molecule TKI class (regorafenib, apatinib, lenvatinib, amlotinib, etc.) medications other than furoquinotinib prior to enrollment, etc;
- Patients using furaquintinib and irinotecan prior to enrollment;
- Those who have participated in a clinical trial of another antitumor drug within 4 weeks prior to enrollment or who are in the process of conducting another clinical trial;
- Other malignancy within the past 5 years, except basal or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;
- The patient has any current disease or condition that interferes with drug absorption or the patient is unable to take furaquintinib orally;
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- Any surgical (except biopsy) or invasive treatment or manipulation within 4 weeks prior to the start of enrollment and the surgical incision has not completely healed (except for intravenous cannulation, puncture drainage, etc.);
- There is pleural effusion, pericardial effusion, ascites, and it causes the patient to cause respiratory syndrome (≥ CTC AE grade 2 dyspnea);
- Clinically significant electrolyte abnormalities as judged by the investigator;
- Patients with current hypertension uncontrolled by medications were defined as patients who had hypertension and could not obtain good control with antihypertensive medication (systolic blood pressure ≥150 mmHg and diastolic blood pressure 100 mmHg);
- Urine routine suggests urinary protein ≥3+ and the amount of urinary protein >3.5g in 24 hours; and
- Patients with current GI disease such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresected tumors, or other conditions that may cause GI bleeding or perforation as determined by the investigator;
- Patients with evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding >30 mL within 3 months, vomiting blood, black stool, blood in stool), hemoptysis (>5 mL of fresh blood within 4 weeks), or a thromboembolic event (including stroke events and/or transient ischemic attack) within 6 months;
- Clinically significant cardiovascular disease including, but not limited to, acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months prior to enrollment; new-onset angina pectoris in the 3 months prior to enrollment; congestive heart failure New York Heart Association (NYHA) classification >2; ventricular arrhythmias requiring pharmacologic therapy;
- Active or uncontrolled serious infection (≥ CTCAE grade 2 infection);
- Women who are pregnant (positive pregnancy test prior to administration) or are breastfeeding;
- Any other disease, clinically significant metabolic abnormality, physical examination abnormality, or laboratory test abnormality that, in the investigator's judgment, gives reason to suspect that the patient has a disease or condition for which the investigational drug is inappropriate (e.g., seizures requiring treatment), or that will interfere with the interpretation of the results of the study, or that puts the patient at high risk;
- Known human immunodeficiency virus (HIV) infection; known history of clinically significant liver disease, including viral hepatitis [known hepatitis B virus (HBV) carriers must exclude active HBV infection, i.e., HBV DNA positive (>1 × 104 copies/mL or >2000 IU/ml); known hepatitis C virus infection (HCV) and HCV antibody positive, or other hepatitis or cirrhosis;
- In the judgment of the investigator, the patient has other factors that may affect the results of the study or cause this study to be forced to be terminated midway, such as alcoholism, drug abuse, other serious illnesses (including psychiatric illnesses) that require comorbid treatment, serious laboratory test abnormalities, concomitant family or societal factors that would affect the patient's safety;
- Patients with brain metastases or/and carcinomatous meningitis;
- Received radiotherapy within 4 weeks prior to enrollment and the lesion observed in this study was in the radiotherapy target area; Comorbidities requiring prolonged treatment with immunosuppressive drugs or systemic or topical corticosteroids at immunosuppressive doses (>10 mg/day of prednisone or other active hormones).
Trial locations and contacts
1 site in 1 country.
Ling Xu, PhD contact
China1 site, 1 recruiting
- Recruiting
First Hospital of China Medical University
Shenyang, Liaoning, 110001
Yunpeng Liu, PhD, 86-24-83282312, cmu_trial@163.com
About this study
Official title: A Real-world Observational Study of Fruquintinib in Combination With Irinotecan and Capecitabine for the Second-line Treatment of Patients With Advanced Colorectal Cancer
This is a real-world observational study of fruquintinib in combination with irinotecan and capecitabine for the second-line treatment of patients with advanced colorectal cancer.
Read the detailed description
This is a real-world observational study of fruquintinib in combination with irinotecan and capecitabine for the second-line treatment of patients with advanced colorectal cancer..The purpose of the study is exploring the real-world efficacy and safety of fruquintinib in combination with irinotecan and capecitabine for the second-line treatment of patients with metastatic colorectal adenocarcinoma.
- Conditions
- Fruquintinib, Irinotecan, Capecitabine, Gastrointestinal Tumours
- Being tested
- fruquintinib, Irinotecan, Capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fruquintinibDevice
Also called elunate
4 mg orally once daily, D1-14, repeated every 3 weeks.
IrinotecanDrug
Also called kaiputuo
180 mg/m2, IV, day 1, repeated every 3 weeks. (Note: If patient has UGT1A1*28 and *6 as pure or double heterozygous variants, irinotecan dose 150 mg/m2, IV, day 1, repeated every 3 weeks, with close clinical observation).
CapecitabineDrug
Also called xiluoda
1000 mg/m2 orally twice daily, D1-14, repeated every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Fruquintinib in combination with irinotecan and capecitabine | Phase I: Treatment phase: 6-8 cycles (as determined by the researcher) 1. Irinotecan: 180 mg/m2, IV, day 1, repeated every 3 weeks. (Note: If patient has UGT1A1*28 and *6 as pure or double heterozygous variants, irinotecan dose 150 mg/m2, IV, day 1, repeated every 3 weeks, with close clinical observation).
2, Capecitabine: 1000 mg/m2 orally twice daily, D1-14, repeated every 3 weeks. 3. Fruquintinib: 4 mg orally once daily, D1-14, repeated every 3 weeks.
Phase II: Maintenance phase:
1, Fruquintinib: 4 mg orally once daily, D1-14, repeated every 3 weeks. 2. Capecitabine: 1000 mg/m2 orally twice daily, D1-14, repeated every 3 weeks Receives: Device: fruquintinib; Drug: Irinotecan; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.
Measured: one year
Secondary outcomes (2)
Objective Response Rate (ORR)
ORR, determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.
Measured: one year
Disease Control Rate (DCR)
Determined using RECIST v1.1 criteria.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start1 Jun 2023
- Primary completionApr 2025 (estimated)
- Study completionJun 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.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunpeng Liu, China Medical University, China
- Investigators
- Yunpeng Liu, PhD, Principal investigator, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169202
- Sponsor's protocol ID
- FIRELIGHT
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 13 Dec 2023
- 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 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Observational Study of Fruquintinib in Combination With Irinotecan and Capecitabine for the Second-line Treatment of Patients With Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06169202
- Acronym / sponsor ID
- FIRELIGHT
- Conditions
- Fruquintinib, Irinotecan, Capecitabine, Gastrointestinal Tumours
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 13 Dec 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 observational study of fruquintinib in combination with irinotecan and capecitabine for the second-line treatment of patients with advanced colorectal cancer.
Detailed description
This is a real-world observational study of fruquintinib in combination with irinotecan and capecitabine for the second-line treatment of patients with advanced colorectal cancer..The purpose of the study is exploring the real-world efficacy and safety of fruquintinib in combination with irinotecan and capecitabine for the second-line treatment of patients with metastatic colorectal adenocarcinoma.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fruquintinib in combination with irinotecan and capecitabine | – | Device: fruquintinib, Drug: Irinotecan, Drug: CapecitabinePhase I: Treatment phase: 6-8 cycles (as determined by the researcher) 1. Irinotecan: 180 mg/m2, IV, day 1, repeated every 3 weeks. (Note: If patient has UGT1A1*28 and *6 as pure or double heterozygous variants, irinotecan dose 150 mg/m2, IV, day 1, repeated every 3 weeks, with close clinical observation). 2, Capecitabine: 1000 mg/m2 orally twice daily, D1-14, repeated every 3 weeks. 3. Fruquintinib: 4 mg orally once daily, D1-14, repeated every 3 weeks. Phase II: Maintenance phase: 1, Fruquintinib: 4 mg orally once daily, D1-14, repeated every 3 weeks. 2. Capecitabine: 1000 mg/m2 orally twice daily, D1-14, repeated every 3 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female patients between the ages of 18-75 years
Key inclusion criteria (11 listed)
- Subjects voluntarily enrolled in the study and signed an informed consent form, were compliant and cooperated with follow-up visits;
- Patients with metastatic colorectal adenocarcinoma confirmed by pathology or histology;
- Patients with second-line metastatic colorectal adenocarcinoma who have failed prior standard first-line treatment (recurrence within 6 months of the end of adjuvant chemotherapy is considered first-line treatment failure);
- Tumor tissue testing at the primary or metastatic site allows enrollment in second-line therapy regardless of whether the KRAS, NRAS, or BRAF genes are wild-type or mutant, and regardless of microsatellite status as MSS/ pMMR or MSI-H/dMMR. For MSI-H/dMMR patients, first-line treatment was similarly allowed for enrollment if immunotherapy was used in the second line;
- Age: 18-75 (inclusive of 18 and 75), male or female;
Key exclusion criteria (21 listed)
- Patients who are allergic to furaquintinib, irinotecan, and capecitabine;
- Received anti-angiogenic small molecule TKI class (regorafenib, apatinib, lenvatinib, amlotinib, etc.) medications other than furoquinotinib prior to enrollment, etc;
- Patients using furaquintinib and irinotecan prior to enrollment;
- Those who have participated in a clinical trial of another antitumor drug within 4 weeks prior to enrollment or who are in the process of conducting another clinical trial;
- Other malignancy within the past 5 years, except basal or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;
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 |
|---|---|---|
| fruquintinibAlso: elunate4 mg orally once daily, D1-14, repeated every 3 weeks. | Device | Fruquintinib in combination with irinotecan and capecitabine |
| IrinotecanAlso: kaiputuo180 mg/m2, IV, day 1, repeated every 3 weeks. (Note: If patient has UGT1A1*28 and *6 as pure or double heterozygous variants, irinotecan dose 150 mg/m2, IV, day 1, repeated every 3 weeks, with close clinical observation). | Drug | Fruquintinib in combination with irinotecan and capecitabine |
| CapecitabineAlso: xiluoda1000 mg/m2 orally twice daily, D1-14, repeated every 3 weeks. | Drug | Fruquintinib in combination with irinotecan and capecitabine |
Primary outcome
Progression-free Survival (PFS)
Time frame: one year
PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.
2 secondary outcomes
Objective Response Rate (ORR)
Time frame: one year
Disease Control Rate (DCR)
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- 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.
Ling Xu, PhD contact
Yunpeng Liu, PhD principal investigator
First Hospital of China Medical University
1 site 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 Irinotecan, run by China Medical University, China 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: status not confirmed, as of the sponsor's last update on 13 Dec 2023. 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.
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 Yunpeng Liu, PhD (86-24-83282312, cmu_trial@163.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: one 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 13 Dec 2023.