Advanced Colorectal CancerNCT05928312
Fruquintinib Combined With Chemotherapy as Third-line /Third-line+ Treatment in Advanced Colorectal Cancer
A study testing Fruquintinib Combined With Chemotherapy in people with Advanced Colorectal Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
To explore the efficacy and safety of fruquintinib combined with chemotherapy as third-line/third-line+ Treatment in advanced metastatic colorectal cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Colorectal Cancer
- What is being tested?
- Fruquintinib Combined With Chemotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 28 Aug 2023to 1 Jun 2026
- Phase
- Interventional
- 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
- Have fully understood the study and voluntarily signed the informed consent
- Age ≥18 years old, male or female
- Advanced metastatic colorectal adenocarcinoma confirmed by histopathology
- The best efficacy evaluation of first-line chemotherapy (mFOLFOX6, XELOX, or FOLFIRI) in previous patients must be partial response (PR) or above or progression-free survival (PFS) ≥1 year, with a first-line drug withdrawal interval of more than 1 year. Pre-adjuvant/neoadjuvant therapy is allowed. If recurrence or metastasis occurs during or within 6 months after completion of adjuvant/neoadjuvant therapy, adjuvant/neoadjuvant therapy is considered a failure of first-line chemotherapy for advanced disease
- The patient has failed at least previous second-line treatment，The use of Cetuximab (KRAS and Braf wild type) and bevacizumab in previous anti-tumor regiments is required，Prior treatment with regorafenib or TAS-102 is permitted
- ECOG status 0-2 points
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- Expected survival ≥12 weeks
- Have at least one measurable lesion (RECIST version 1.1)
- Inadequate bone marrow reserve or organ function, as demonstrated by any of the following laboratory values: Absolute neutrophil count (ANC) ≥1.5×109/L Platelet count ≥80×109 / L Hemoglobin≥80 g/L（<8 g/dL） Serum albumin ≥3g/dL Alanine aminotransferase <2.5 × upper limit of normal (ULN) if no demonstrable liver metastases or <5 × ULN in the presence of liver metastases. Aspartate aminotransferase (AST) <2.5 × ULN if no demonstrable liver metastases or < 5 × ULN in the presence of liver metastases. Total bilirubin (TBL)<1.5 × ULN Creatinine≤ 1.5 × ULN concurrent with creatinine clearance ≤50 mL/min (measured or calculated by the Cockcroft-Gault equation) confirmation of creatinine clearance is only required when creatinine is ≤1.5 × ULN.
- Fertile male or female patients voluntarily used effective contraceptive methods, such as double barrier methods, condoms, oral or injectable contraceptives, intrauterine devices, etc., during the study period and within 6 months of the last study dose. All female patients will be considered fertile unless they have undergone natural menopause, artificial menopause, or sterilization (such as hysterectomy, bilateral adnexectomy, or irradiation of radioactive ovaries).
- Good compliance, cooperate with follow-up.
Who cannot join
- 1: Patients with known dMMR or MSI-H colorectal cancer who have not previously used anti-PD-1 or PD-L1 inhibitors
- 2: Previously received small molecule targeted drug therapy with fuquinitinib
- 3: Symptomatic brain or meningeal metastases (except those with brain metastases that have undergone local radiotherapy or surgery for more than 6 months and whose disease control is stable)
- 4: Severe infection (such as intravenous infusion of antibiotics, antifungals, or antiviral drugs) within 4 weeks prior to treatment, or unexplained fever > 38.5 ° C during screening/first administration
- 5: Have high blood pressure that is not well controlled by antihypertensive medications (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg)
- 6: Obvious clinical bleeding symptoms or obvious bleeding tendency within 3 months prior to treatment (bleeding > 30 mL within 3 months, hematemesis, black stool, blood in the stool), hemoptysis (> 5 mL of fresh blood within 4 weeks), etc. Or treatment of arterial venous thrombosis events within the preceding 6 months, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism
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- 7: Long-term anticoagulant therapy with warfarin or heparin, or long-term antiplatelet therapy (aspirin ≥300 mg/day or clopidogrel ≥75 mg/day) is required
- 8: During screening, it was found that the tumor invaded large vascular structures, such as pulmonary artery, superior vena cava or inferior vena cava, etc., and the researchers judged that there was a risk of major bleeding
- 9: The patient currently has gastrointestinal diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresectosed tumors, or other conditions determined by researchers that may cause gastrointestinal bleeding or perforation .Active heart disease, including myocardial infarction, severe/unstable angina, occurs 6 months before treatment. Left ventricular ejection fraction <50% by echocardiography showed poor arrhythmia control.
- 10: Patients with other malignant tumors (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) in the past 5 years or at the same time
- 11: Known allergy to the investigational drug or any of its excipients
- 12: Active or uncontrolled severe infection
- Known human immunodeficiency virus (HIV) infection
- Known history of clinically significant liver disease, including viral hepatitis [active HBV infection, i.e., positive HBV DNA (>1×104 copies /mL or >2000 IU/ml) must be excluded for known hepatitis B virus (HBV) carriers
- Known hepatitis C virus infection (HCV) and HCV RNA positive (>1×103 copies /mL), or other hepatitis, cirrhosis]
- 13. Any other medical condition, clinically significant metabolic abnormality, physical abnormality or laboratory abnormality, in which, in the investigator's judgment, there is reason to suspect that the patient has a medical condition or condition that is not suitable for the use of the investigational drug (such as having seizures and requiring treatment), or which would affect the interpretation of the study results or place the patient at high risk
- 14. Urine routine indicated urinary protein ≥2+, and 24-hour urinary protein quantity >1.0g.
- 15. Incomplete healing of skin wounds, surgical sites, trauma sites, severe mucosal ulcers or fractures
- 16. Stroke events and/or transient cerebral ischemia occurred within 12 months prior to enrollment
- 17. The patient has any current disease or condition that affects drug absorption, or the patient is unable to take fuquintinib orally
- 18. Women who are pregnant (positive pregnancy test before medication) or breastfeeding
- 19. The patients considered by the investigators to be unsuitable for inclusion in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhejiang Cancer Institute & Hospital
Hangzhou, Zhejing
Wangxia Lv, 13757141026, lvwangxia@163.com
HaiJun Zhong
About this study
Official title: The Efficacy and Safety of Fruquintinib Combined With Chemotherapy as Third-line /Third-line+ Treatment in Advanced Colorectal Cancer: An Open， Single-center Study
To explore the efficacy and safety of fruquintinib combined with chemotherapy as third-line/third-line+ Treatment in advanced metastatic colorectal cancer
Read the detailed description
Due to the limited efficacy of third-line treatment, the previously effective chemotherapy regimen is a new treatment mode. RE-OPEN, RE-OX and a Korean study confirmed that mCRC patients who had previously been effectively treated with oxaliplatin were retreated with oxaliplatin on the third line to help them achieve OS for 14.5 to 18.5 months. At the same time, a phase III randomized SUNLIGHT study showed good efficacy at the ASCO-GI Congress in 2023. The above studies show that the regimen of antivascular drugs combined with chemotherapy has a tendency to improve the survival of patients with third-line advanced colorectal cancer.
In order to further improve the efficacy of fruquintinib, we conducted a clinical study of fruquintinib combined with chemotherapy to observe the efficacy and safety of Third-line/Third-line+ treatment of advanced colorectal cancer, and to provide a more effective treatment plan for third-line and above treatment for advanced colorectal cancer patients.
- Conditions
- Advanced Colorectal Cancer
- Being tested
- Fruquintinib Combined With Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruquintinib Combined With ChemotherapyDrug
Also called Fruquintinib oxaliplatin irinotecan
1.Security introduction period:
[1] Safety introduction period (N=6), fruquintinib combined with three-week regimen:
- Fruquintinib: Three-week regimen of combined chemotherapy: 4mg/d, orally, once a day, taking the drug for 2 weeks and stopping the drug for 1 week, 3 weeks as a treatment cycle.
[2] Safety introduction period (N=6), fruquintinib combined 2-week regimen:
- Fruquintinib: two-week combination chemotherapy regimen: 4mg/d, orally, once a day, taking the drug for 3 weeks and stopping the drug for 1 week, 4 weeks as a treatment cycle.
- Dose expansion phase design(N=60) Cohort 1 (30 patients) : Fruquintinib combined with oxaliplatin. Cohort 2 (30 patients) : Fruquintinib combined with irinotecan .
| Study group | Role | What they receive |
|---|---|---|
| Advanced CRC | Experimental | Patients with Advanced CRC were given Fruquintinib Combine With Chemotherapy. Receives: Drug: Fruquintinib Combined With Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity(DLT)
Usually refers to the highest dose at which a subject's probability of developing DLT does not exceed the probability of target toxicity during the regime-specified DLT observation period.
Measured: up to 12 months
Objective response rate (ORR)
CR + PR rate according to the RECIST version 1.1 guidelines.
Measured: up to 12 months
Secondary outcomes (3)
Progression Free Survival (PFS)
To assess the efficacy of Surufatinib Combine With Immunotherapy and Chemotherapy as second-line therapy to Advanced CRC, patients by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Measured: up to 12 months
Overall survival time
OS was calculated from the date of pharmacy to death from any cause.
Measured: up to 36 months
Assess the anti-tumor activity:DCR
Disease control rate (DCR):CR + PR + SD rate according to the RECIST version 1.1 guidelines.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start28 Aug 2023 (estimated)
- Primary completion28 Jun 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wangxia LV, Zhejiang Cancer Hospital
- Investigators
- Wangxia Lv, Study chair, Zhejiang Cancer Institute & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928312
- Sponsor's protocol ID
- HMPL-013-FLAG-C127
- Status last verified
- Jul 2023
- First submitted
- 19 Jun 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Fruquintinib Combined With Chemotherapy as Third-line /Third-line+ Treatment in Advanced Colorectal Cancer: An Open， Single-center Study
- ClinicalTrials.gov ID
- NCT05928312
- Acronym / sponsor ID
- HMPL-013-FLAG-C127
- Conditions
- Advanced Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 28 Aug 2023 (estimated)
- Primary completion
- 28 Jun 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 3 Jul 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.
To explore the efficacy and safety of fruquintinib combined with chemotherapy as third-line/third-line+ Treatment in advanced metastatic colorectal cancer
Detailed description
Due to the limited efficacy of third-line treatment, the previously effective chemotherapy regimen is a new treatment mode. RE-OPEN, RE-OX and a Korean study confirmed that mCRC patients who had previously been effectively treated with oxaliplatin were retreated with oxaliplatin on the third line to help them achieve OS for 14.5 to 18.5 months. At the same time, a phase III randomized SUNLIGHT study showed good efficacy at the ASCO-GI Congress in 2023. The above studies show that the regimen of antivascular drugs combined with chemotherapy has a tendency to improve the survival of patients with third-line advanced colorectal cancer.
In order to further improve the efficacy of fruquintinib, we conducted a clinical study of fruquintinib combined with chemotherapy to observe the efficacy and safety of Third-line/Third-line+ treatment of advanced colorectal cancer, and to provide a more effective treatment plan for third-line and above treatment for advanced colorectal cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced CRC | Experimental | Drug: Fruquintinib Combined With ChemotherapyPatients with Advanced CRC were given Fruquintinib Combine With Chemotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Have fully understood the study and voluntarily signed the informed consent
- Age ≥18 years old, male or female
- Advanced metastatic colorectal adenocarcinoma confirmed by histopathology
- The best efficacy evaluation of first-line chemotherapy (mFOLFOX6, XELOX, or FOLFIRI) in previous patients must be partial response (PR) or above or progression-free survival (PFS) ≥1 year, with a first-line drug withdrawal interval of more than 1 year. Pre-adjuvant/neoadjuvant therapy is allowed. If recurrence or metastasis occurs during or within 6 months after completion of adjuvant/neoadjuvant therapy, adjuvant/neoadjuvant therapy is considered a failure of first-line chemotherapy for advanced disease
- The patient has failed at least previous second-line treatment，The use of Cetuximab (KRAS and Braf wild type) and bevacizumab in previous anti-tumor regiments is required，Prior treatment with regorafenib or TAS-102 is permitted
Key exclusion criteria (22 listed)
- 1: Patients with known dMMR or MSI-H colorectal cancer who have not previously used anti-PD-1 or PD-L1 inhibitors
- 2: Previously received small molecule targeted drug therapy with fuquinitinib
- 3: Symptomatic brain or meningeal metastases (except those with brain metastases that have undergone local radiotherapy or surgery for more than 6 months and whose disease control is stable)
- 4: Severe infection (such as intravenous infusion of antibiotics, antifungals, or antiviral drugs) within 4 weeks prior to treatment, or unexplained fever > 38.5 ° C during screening/first administration
- 5: Have high blood pressure that is not well controlled by antihypertensive medications (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 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 Combined With ChemotherapyAlso: Fruquintinib oxaliplatin irinotecan1.Security introduction period: [1] Safety introduction period (N=6), fruquintinib combined with three-week regimen: 1. Fruquintinib: Three-week regimen of combined chemotherapy: 4mg/d, orally, once a day, taking the drug for 2 weeks and stopping the drug for 1 week, 3 weeks as a treatment cycle. [2] Safety introduction period (N=6), fruquintinib combined 2-week regimen: 1. Fruquintinib: two-week combination chemotherapy regimen: 4mg/d, orally, once a day, taking the drug for 3 weeks and stopping the drug for 1 week, 4 weeks as a treatment cycle. 2. Dose expansion phase design(N=60) Cohort 1 (30 patients) : Fruquintinib combined with oxaliplatin. Cohort 2 (30 patients) : Fruquintinib combined with irinotecan . | Drug | Advanced CRC |
Primary outcome
Dose-limiting toxicity(DLT)
Time frame: up to 12 months
Usually refers to the highest dose at which a subject's probability of developing DLT does not exceed the probability of target toxicity during the regime-specified DLT observation period.
Objective response rate (ORR)
Time frame: up to 12 months
CR + PR rate according to the RECIST version 1.1 guidelines.
3 secondary outcomes
Progression Free Survival (PFS)
Time frame: up to 12 months
Overall survival time
Time frame: up to 36 months
Assess the anti-tumor activity:DCR
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
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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.
Wangxia Lv study chair
Zhejiang Cancer Institute & Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fruquintinib Combined With Chemotherapy in people with Advanced Colorectal Cancer, run by Zhejiang Cancer Hospital 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 22 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 20 Jul 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 Wangxia Lv (13757141026, lvwangxia@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity(DLT) (time frame: up to 12 months). The study lists 2 primary outcomes in all. 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 20 Jul 2023.