Colorectal CancerPhase 2NCT06010888
Fruquintinib With mFOLFOX6/FOLFIRI as First-Line Therapy for Conversion Surgery in mCRC
A Phase 2 study testing Fruquintinib+mFOLFOX6/FOLFIRI in people with Colorectal Cancer, run by Fudan University at 1 site in China.
Trial summary
The goal of this clinical trial is to learn about the efficacy and safety of Fruquintinib with mFOLFOX6/FOLFIRI in patients with mCRC. The main question it aims to answer is: The conversion surgery rate of the therapy mentioned above. The ORR, R0 surgery rate, DCR, PFS, OS, and safety will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Fruquintinib+mFOLFOX6/FOLFIRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2023to 31 Mar 2026
- 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
- Provide written informed consent to participate in the study voluntarily.
- Male or female aged 18-75.
- Metastatic colorectal adenocarcinoma confirmed by histology or cytology.
- Have not received systematic anti-tumor therapy before; Patients who have received neoadjuvant/adjuvant therapy may be screened from the time of last chemotherapy to recurrence or progression more than 6 months.
- RAS/BRAF mutation status and UGT1A1*28/*6 gene polymorphism typing should be determined before enrollment.
- The ECOG PS score is 0 or 1.
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- Life expectancy is at least 3 months.
- According to RECIST 1.1, the investigators evaluated that there were measurable lesions at baseline (according to RECIST 1.1), which could be measured if they had not received local treatment such as radiotherapy (lesions located within the area of previous radiotherapy could also be selected as target lesions if progression was confirmed).
- The function of vital organs meets the following requirements (no blood component, cell growth factor correction therapy drugs are allowed within 14 days before the first use of the study drug);
- Absolute neutrophil count (ANC) ≥1.5×109/L
- Platelet ≥100×109/L;
- Hemoglobin ≥9g/dL;
- Serum albumin ≥2.5g/dL;
- Total bilirubin ≤1.5 × ULN; ALT and AST≤2.5 × ULN, if there is liver metastasis, ALT and AST≤5 × ULN;
- Serum creatinine ≤1.5 × ULN or creatinine clearance > 60 mL/min (Cockcroft-Gault);
- Activated partial thromboplastin time (APTT) and International Normalized ratio (INR) ≤1.5 × ULN (for stable dose anticoagulant therapy such as low molecular weight heparin or warfarin and INR within the intended therapeutic range of anticoagulants can be screened)
- Fertile female subjects are required to have a negative serum pregnancy test within 72 hours before the first dosing, are not breastfeeding, and use effective contraception (such as Iuds, contraceptives, or condoms) during the trial period and for at least 6 months after the last dosing of the study drug; Male subjects whose partner is a fertile woman should be surgically sterilized or agree to use effective contraception during the trial period and within 3 months after the last dose of the study drug. Sperm donation is not allowed during the study period;
Who cannot join
- Local radiotherapy was received within 4 weeks prior to the first administration of the study drug, and adverse events due to radiotherapy have not returned to baseline levels. Participants who received palliative radiotherapy for peripheral sites (such as bone metastases) before 4 weeks may be admitted to the study, but must have recovered from any acute adverse effects;
- Known active central nervous system (CNS) metastases and/or cancerous meningitis. Participants who have previously received BMS may participate in treatment provided they have stable BMS and have not been treated with steroids for BMS for at least 28 days prior to study start. This exception does not include cancerous meningitis, as patients with cancerous meningitis are excluded regardless of clinical stability;
- Major surgery, open biopsy, or severe trauma occurred 28 days before the first medication;
- Previous history of allergy to fluorouracil or irinotecan;
- Have high blood pressure that is not well controlled by antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg)
- Subjects have poorly controlled cardiovascular clinical symptoms or diseases, including but not limited to:
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- NYHA grade II or above heart failure; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmias that remain poorly controlled without or after clinical intervention.
- 7. Clinically significant bleeding symptoms or definite bleeding tendency, such as gastrointestinal bleeding, hemorrhagic ulcer or vasculitis, have occurred within 3 months before the first medication.
- 8. Arteriovenous thrombosis events occurring within 6 months before the first medication, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, and cerebral infarction), deep vein thrombosis and pulmonary embolism, etc. Shallow vein thrombosis can be included after being determined by the researcher.
- 9. There is another malignant tumor that is progressing or in need of aggressive treatment, except for non-melanoma skin cancer and cervical cancer in situ for which potential treatment has been performed.
- 10. In the investigator's judgment, the subject has other factors that may lead to the forced termination of the study, such as other serious medical conditions (including mental illness) requiring co-treatment, serious abnormalities in laboratory test values, and family or social factors that may affect the subject's safety or the circumstances in which the trial data are collected.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xinxiang Li, MD, Li, lxx1149@163.com
About this study
Official title: Fruquintinib With mFOLFOX6/FOLFIRI as First-Line Therapy for Conversion Surgery in mCRC: An Exploratory Clinical Trial
The goal of this clinical trial is to learn about the efficacy and safety of Fruquintinib with mFOLFOX6/FOLFIRI in patients with mCRC. The main question it aims to answer is:
The conversion surgery rate of the therapy mentioned above. The ORR, R0 surgery rate, DCR, PFS, OS, and safety will be evaluated.
- Conditions
- Colorectal Cancer
- Being tested
- Fruquintinib+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+mFOLFOX6/FOLFIRIDrug
Fruquintinib: 4mg po qd, d1-d21, q4w with mFOLFOX6/FOLFIRI (standard)
| Study group | Role | What they receive |
|---|---|---|
| Fruquintinib+mFOLFOX6/FOLFIRI | Experimental | Not described Receives: Drug: Fruquintinib+mFOLFOX6/FOLFIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate（ORR）
Objective Response Rate: The proportion of participants in the analyzed population who developed complete (CR) or partial response (PR) according to RECIST 1.1 criteria.
Measured: through study completion, an average of 2 year
Secondary outcomes (4)
R0 Surgery Rate
R0 Surgery Rate: R0 corresponds to resection for cure or complete remission.
Measured: through study completion, an average of 2 year
Disease Control Rate（DCR）
Disease Control Rate: The proportion of subjects in the analyzed population who achieved CR, PR, or stable disease (SD) according to RECIST 1.1 criteria.
Measured: through study completion, an average of 2 year
Progression Free Survival（PFS）
Progression-Free Survival: Time from patient admission to first radiographic disease progression (RECIST 1.1 criteria) or death (whichever occurs first).
Measured: through study completion, an average of 2 year
Overall Survival（OS）
Overall Survival: From the time of patient admission to the time of subject's death, at the end of the study, if the subject is still alive, the last known date of subject's survival is the deletion date.
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start31 Oct 2023 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Mar 2026 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI XIN-XIANG, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010888
- Sponsor's protocol ID
- HMPL-013-SH-CRC-101
- Status last verified
- Aug 2023
- First submitted
- 21 Aug 2023
- Last updated
- 25 Aug 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 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fruquintinib With mFOLFOX6/FOLFIRI as First-Line Therapy for Conversion Surgery in mCRC: An Exploratory Clinical Trial
- ClinicalTrials.gov ID
- NCT06010888
- Acronym / sponsor ID
- HMPL-013-SH-CRC-101
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 31 Oct 2023 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 25 Aug 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.
The goal of this clinical trial is to learn about the efficacy and safety of Fruquintinib with mFOLFOX6/FOLFIRI in patients with mCRC. The main question it aims to answer is:
The conversion surgery rate of the therapy mentioned above. The ORR, R0 surgery rate, DCR, PFS, OS, and safety will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fruquintinib+mFOLFOX6/FOLFIRI | Experimental | Drug: Fruquintinib+mFOLFOX6/FOLFIRI |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Provide written informed consent to participate in the study voluntarily.
- Male or female aged 18-75.
- Metastatic colorectal adenocarcinoma confirmed by histology or cytology.
- Have not received systematic anti-tumor therapy before; Patients who have received neoadjuvant/adjuvant therapy may be screened from the time of last chemotherapy to recurrence or progression more than 6 months.
- RAS/BRAF mutation status and UGT1A1*28/*6 gene polymorphism typing should be determined before enrollment.
Key exclusion criteria (11 listed)
- Local radiotherapy was received within 4 weeks prior to the first administration of the study drug, and adverse events due to radiotherapy have not returned to baseline levels. Participants who received palliative radiotherapy for peripheral sites (such as bone metastases) before 4 weeks may be admitted to the study, but must have recovered from any acute adverse effects;
- Known active central nervous system (CNS) metastases and/or cancerous meningitis. Participants who have previously received BMS may participate in treatment provided they have stable BMS and have not been treated with steroids for BMS for at least 28 days prior to study start. This exception does not include cancerous meningitis, as patients with cancerous meningitis are excluded regardless of clinical stability;
- Major surgery, open biopsy, or severe trauma occurred 28 days before the first medication;
- Previous history of allergy to fluorouracil or irinotecan;
- Have high blood pressure that is not 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+mFOLFOX6/FOLFIRIFruquintinib: 4mg po qd, d1-d21, q4w with mFOLFOX6/FOLFIRI (standard) | Drug | Fruquintinib+mFOLFOX6/FOLFIRI |
Primary outcome
Objective Response Rate（ORR）
Time frame: through study completion, an average of 2 year
Objective Response Rate: The proportion of participants in the analyzed population who developed complete (CR) or partial response (PR) according to RECIST 1.1 criteria.
4 secondary outcomes
R0 Surgery Rate
Time frame: through study completion, an average of 2 year
Disease Control Rate（DCR）
Time frame: through study completion, an average of 2 year
Progression Free Survival（PFS）
Time frame: through study completion, an average of 2 year
Overall Survival（OS）
Time frame: through study completion, an average of 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 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.
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+mFOLFOX6/FOLFIRI in people with Colorectal Cancer, run by Fudan University 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 17 inclusion and 11 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 25 Aug 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate（ORR） (time frame: through study completion, an average of 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 25 Aug 2023.