Metastasis Colorectal CancerPhase 2NCT06255379
Study of Fruquintinib Combined With Tegafur Gimeracil Oteracil in Patients With Metastatic Colorectal Cancer
A Phase 2 study testing Fuquinitinib+Tegafur Gimeracil Oteracil in people with Metastasis Colorectal Cancer and Colon Cancer, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
Trial summary
This is an Open, Single-arm, Multicenter, Prospective Phase II Study of Fuquinitinib Combined With Tegafur Gimeracil Oteracil in the Third-line Treatment of Patients With Advanced Metastatic CRC Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastasis Colorectal Cancer, Colon Cancer, Rectal Cancer
- What is being tested?
- Fuquinitinib+Tegafur Gimeracil Oteracil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2024to 21 Mar 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 and ≤ 75 years of age;
- Have fully understood and voluntarily sign the ICF for this study (the icf must be signed before any trial-specific procedures are performed);Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure;
- Histologically and/or cytologically documented metastatic colorectal adenocarcinoma;
- Refractory to at least second line standard treatment containing fluorouracil, oxaliplatin and irinotecan;
- At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan or 20mm by conventional CT scan);
- ECOG performance status of 0-1;
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- Life expectancy ≥ 12 weeks;
- No previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitor (TKI);
- Adequate hepatic, renal, heart, and hematologic functions;
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
Who cannot join
- Pregnant or lactating women;
- Any factors that influence the usage of oral administration or any disease or condition that affects drug absorption;
- Previous treatment with Tegafur Gimeracil Oteracil ;
- Participated in clinical trials of other drugs within four weeks before enrollment;
- Received other systemic anti-tumor therapy within 4 weeks before enrollment, including chemotherapy, signal transduction inhibitors, hormone therapy and immunotherapy;
- International normalized ratio (INR) > 1.5 or partially activated prothrombin time (APTT) > 1.5 × ULN;
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- Clinically significant electrolyte abnormalities;
- Subjected with hypertension that cannot be controlled by drugs, which is specified as: systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg;
- Unrelieved toxic reactions higher than CTCAE V5.0 grade 1 caused by any previous anti-cancer treatment;
- Incomplete healing of skin wound, surgical site, traumatic site, severe mucosal ulcer or fracture;
- Conditions that may cause gastrointestinal bleeding and perforation determined by the researcher;
- History of arterial thrombosis or deep venous thrombosis within 6 months before enrollment;
- Stroke and / or transient cerebral ischemia occurred within 12 months before enrollment;
- Cardiovascular diseases with significant clinical significance;
- LVEF<50%;
- Congestive heart failure New York Heart Association (NYHA) grade > 2;
- Evidence of CNS metastasis;
- Previous treatment with VEGFR inhibition;
- Ventricular arrhythmias requiring drug treatment;
- Proteinuria ≥ 2+ (1.0g/24hr);
- Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy;
- Other malignant tumors in the past 5 years, except skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;
- Active infection that is not controlled clinically, such as acute pneumonia, active hepatitis B or hepatitis C;
- By judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510000
Li xiaoyan, +86 020-81887233 ext. 35943
About this study
Official title: An Open, Single-arm, Multicenter, Prospective Phase II Study of Fuquinitinib Combined With Tegafur Gimeracil Oteracil in the Third-line Treatment of Patients With Advanced Metastatic CRC
This is an Open, Single-arm, Multicenter, Prospective Phase II Study of Fuquinitinib Combined With Tegafur Gimeracil Oteracil in the Third-line Treatment of Patients With Advanced Metastatic CRC
- Conditions
- Metastasis Colorectal Cancer, Colon Cancer, Rectal Cancer
- Being tested
- Fuquinitinib+Tegafur Gimeracil Oteracil
- Keywords
- Colorectal cancer, Fruquintinib, Tegafur Gimeracil Oteracil, mCRC
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fuquinitinib+Tegafur Gimeracil OteracilDrug
Fuquinitinib:5 mg once daily, 2 weeks on/1 week off,q3w; Tegafur Gimeracil Oteracil:BSA(body surface area)< 1.2m2,40mg/m2,p.o,bid,2 weeks on/1 week off,q3w; 1.2m2 < BSA （body surface area）< 1.5m2,50mg/m2,p.o,bid,2 weeks on/1 week off,q3w;BSA（body surface area） >1.5m2,60mg/m2,p.o,bid,2 weeks on/1 week off,q3w;
| Study group | Role | What they receive |
|---|---|---|
| Fuquinitinib +Tegafur Gimeracil Oteracil | Experimental | Not described Receives: Drug: Fuquinitinib+Tegafur Gimeracil Oteracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator
Measured: from randomization up to progressive disease or EOT due to any cause, up to 2 years
Secondary outcomes (4)
Objective response rate(ORR)
Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
Measured: from randomization up to progressive disease or EOT due to any cause, up to 2 years
Disease control rate(DCR)
DCR was defined as the percentage of participants who have a confirmed complete response（CR） or partial response（PR） or stable disease（SD） per RECIST 1.1 as assessed by investigator
Measured: from randomization up to progressive disease or EOT due to any cause, up to 2 years
Overall survival (OS)
OS is the time from enrollment to death due to any cause.
Measured: from randomization up to progressive disease or EOT due to any cause, up to 3 years
adverse events (AE)
overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use.
Measured: from day 1 of first dosing to 30days after permanent discontinuation of fruquintinib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start6 May 2024 (estimated)
- Primary completion21 Mar 2027 (estimated)
- Study completion21 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastasis Colorectal CancerStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255379
- Sponsor's protocol ID
- ZF-2023-387-01
- Other IDs
- HMPL-013-SC-CRC102
- Status last verified
- Apr 2024
- First submitted
- 4 Feb 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- 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 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single-arm, Multicenter, Prospective Phase II Study of Fuquinitinib Combined With Tegafur Gimeracil Oteracil in the Third-line Treatment of Patients With Advanced Metastatic CRC
- ClinicalTrials.gov ID
- NCT06255379
- Acronym / sponsor ID
- ZF-2023-387-01
- Conditions
- Metastasis Colorectal Cancer, Colon Cancer, Rectal Cancer
- Keywords
- Colorectal cancer, Fruquintinib, Tegafur Gimeracil Oteracil, mCRC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 6 May 2024 (estimated)
- Primary completion
- 21 Mar 2027 (estimated)
- Study completion
- 21 Mar 2027 (estimated)
- First posted
- 13 Feb 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.
This is an Open, Single-arm, Multicenter, Prospective Phase II Study of Fuquinitinib Combined With Tegafur Gimeracil Oteracil in the Third-line Treatment of Patients With Advanced Metastatic CRC
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fuquinitinib +Tegafur Gimeracil Oteracil | Experimental | Drug: Fuquinitinib+Tegafur Gimeracil Oteracil |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥ 18 and ≤ 75 years of age;
- Have fully understood and voluntarily sign the ICF for this study (the icf must be signed before any trial-specific procedures are performed);Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure;
- Histologically and/or cytologically documented metastatic colorectal adenocarcinoma;
- Refractory to at least second line standard treatment containing fluorouracil, oxaliplatin and irinotecan;
- At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan or 20mm by conventional CT scan);
Key exclusion criteria (24 listed)
- Pregnant or lactating women;
- Any factors that influence the usage of oral administration or any disease or condition that affects drug absorption;
- Previous treatment with Tegafur Gimeracil Oteracil ;
- Participated in clinical trials of other drugs within four weeks before enrollment;
- Received other systemic anti-tumor therapy within 4 weeks before enrollment, including chemotherapy, signal transduction inhibitors, hormone therapy and immunotherapy;
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 |
|---|---|---|
| Fuquinitinib+Tegafur Gimeracil OteracilFuquinitinib:5 mg once daily, 2 weeks on/1 week off,q3w; Tegafur Gimeracil Oteracil:BSA(body surface area)< 1.2m2,40mg/m2,p.o,bid,2 weeks on/1 week off,q3w; 1.2m2 < BSA （body surface area）< 1.5m2,50mg/m2,p.o,bid,2 weeks on/1 week off,q3w;BSA（body surface area） >1.5m2,60mg/m2,p.o,bid,2 weeks on/1 week off,q3w; | Drug | Fuquinitinib +Tegafur Gimeracil Oteracil |
Primary outcome
Progression Free Survival (PFS)
Time frame: from randomization up to progressive disease or EOT due to any cause, up to 2 years
PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator
4 secondary outcomes
Objective response rate(ORR)
Time frame: from randomization up to progressive disease or EOT due to any cause, up to 2 years
Disease control rate(DCR)
Time frame: from randomization up to progressive disease or EOT due to any cause, up to 2 years
Overall survival (OS)
Time frame: from randomization up to progressive disease or EOT due to any cause, up to 3 years
adverse events (AE)
Time frame: from day 1 of first dosing to 30days after permanent discontinuation of fruquintinib
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 29 Apr 2024.
- Individual participant dataSharing planned: No
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CRC
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.
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 Fuquinitinib+Tegafur Gimeracil Oteracil in people with Metastasis Colorectal Cancer and Colon Cancer, run by Guangzhou University of Traditional Chinese Medicine 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 10 inclusion and 24 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 29 Apr 2024. 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?
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 Yang xiaobing, PhD (+86 135-8030-9705, yangxiaobing2002@126.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, up to 2 years). 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 29 Apr 2024.