Metastatic Colorectal CancerPhase 4NCT06118762
Clinical Study of Fruquintinib Combined With Raltitrexed in the Treatment of Metastatic Colorectal Cancer
A Phase 4 study testing Fruquintinib in people with Metastatic Colorectal Cancer, run by The First Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
To evaluate the efficacy and safety of Fruquintinib combined with Raltitrexed in the treatment of metastatic colorectal cancer that progressed or could not be tolerated after previous fluorouracil, oxaliplatin, and irinotecan based therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Fruquintinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2023to 1 Oct 2026
- Phase
- Phase 4
- 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 years and older
- 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, gender unlimited;
- Advanced metastatic colorectal adenocarcinoma confirmed by histopathology;
- The patient progressed or was intolerant after receiving at least previous standard therapy containing fluorouracil, oxaliplatin, and irinotecan.
- Each first-line treatment must include one or more chemotherapeutic agents for a duration of ≥1 cycle;
- Allow pre-adjuvant/neoadjuvant therapy. 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;
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- Prior chemotherapy combined with cetuximab or bevacizumab is permitted;
- Have at least one measurable lesion (RECIST 1.1 standard);
- Eastern Cooperative Oncology Group (ECOG) physical condition 0-1 score;
- Expected survival ≥12 weeks;
- The functions of vital organs during the first 14 days of enrollment meet the following requirements (the use of any blood components and cell growth factors during the first 14 days of enrollment is not allowed) :
- Absolute neutrophil count ≥1.5×109/L;
- Platelet ≥80×109/L;
- Hemoglobin ≥8g/dL;
- Total bilirubin < 1.5 × upper limit of normal（ULN）;
- Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) < 2.5 × ULN (< 5 × ULN in patients with liver metastasis);
- Serum creatinine ≤1 × ULN;
- endogenous creatinine clearance > 50ml/min;
- Women of childbearing age or men whose partners wish to have children need to take effective contraceptive measures.
Who cannot join
- Previous treatment with Fruquintinib or other anti-vascular endothelial growth factor receptor (VEGFR) inhibitors such as Apatinib, Regorafenib, and Anlotinib;
- Previous treatment with Raltitrexed;
- Participated in other drug clinical trials and received at least one drug therapy within four weeks prior to enrollment or received other systemic anti-tumor therapy, including chemotherapy, signal transduction inhibitors, hormone therapy, and immunotherapy within four weeks prior to enrollment;
- The patient currently has a disease or condition that affects drug absorption, or the patient cannot take Fruquintinib orally;
- The patient currently has gastrointestinal diseases such as gastric and duodenal active ulcers, ulcerative colitis, or active bleeding from unresectable tumors, or other conditions determined by researchers that may cause gastrointestinal bleeding or perforation;
- Patients with active bleeding or bleeding tendency;
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- History of severe cardiovascular and cerebrovascular diseases:
- Cerebrovascular accident (excluding lacunar infarction, minor cerebral ischemia, or transient ischemic attack), myocardial infarction, unstable angina, and poorly controlled arrhythmias (including QTc interval ≥ 450ms for men and 470 ms for women) within 6 months prior to first administration of the study drug (QTc interval Fridericia) Formula calculation);
- New York Heart Association (NYHA) Heart Function Rating \> Grade II or left ventricular ejection fraction (LVEF) < 50%;
- Have had other malignancies within the past 5 years, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;
- Clinically uncontrolled active infections, such as acute pneumonia, active hepatitis B or C (hepatitis B virus infection regardless of drug control, hepatitis B virus DNA≥1×104 copies /mL or \> 2000 IU/ml);
- There is known to be symptomatic central nervous system metastasis and/or cancerous meningitis. Participants with previously treated brain metastases may participate in the trial if their condition is stable (no evidence of radiographic progression at least 4 weeks prior to initial administration of the trial treatment), repeated radiographic studies confirm no evidence of new brain metastases or enlargement of the original brain metastases, and no steroid therapy is required at least 14 days prior to initial administration of the trial treatment. This exception does not include cancerous meningitis, which should be excluded regardless of whether it is clinically stable;
- Women who are pregnant (positive pregnancy test before medication) or breastfeeding;
- The patient currently has hypertension that cannot be controlled by drugs, which is prescribed as: systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg after taking antihypertensive drugs;
- Urine routine indicates urinary protein ≥2+, or 24-hour urinary protein volume \> 1.0g;
- 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, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Xiaodong Peng, pxddhbb@163.com
About this study
Official title: A Single-arm, Open, Multicenter Clinical Study of Fruquintinib Combined With Raltitrexed in the Treatment of Metastatic Colorectal Cancer
To evaluate the efficacy and safety of Fruquintinib combined with Raltitrexed in the treatment of metastatic colorectal cancer that progressed or could not be tolerated after previous fluorouracil, oxaliplatin, and irinotecan based therapy
Read the detailed description
To evaluate the progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety of Fruquintinib combined with Raltitrexed in 30 patients with metastatic colorectal cancer who had progressed or could not tolerate fluorouracil, oxaliplatin, and irinotecan based therapy.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Fruquintinib
- Keywords
- metastatic colorectal cancer, Fruquintinib, Raltitrexed
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FruquintinibDrug
Also called Raltitrexed
Fruquintinib capsule is taken orally once a day, 5 mg each time, and taken for 2 weeks and stopped for 1 week, every 21 days (3 weeks) for a cycle. Raltitrexed: 3 mg/m2 intravenously, on the first day of each cycle, for a treatment cycle of 3 weeks. Combination treatment until toxicity becomes intolerable, disease progression, or death.
| Study group | Role | What they receive |
|---|---|---|
| Fruquintinib combined with Raltitrexed group | Experimental | Fruquintinib combined with Raltitrexed therapy Receives: Drug: Fruquintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
The time from enrollment to disease progression or death
Measured: From date of randomization until the date of first documented progression or date of death
Secondary outcomes (4)
Objective response rate (ORR)
Proportion of patients with complete or partial response
Measured: through study completion, an average of 1 year
Disease control rate (DCR)
Proportion of patients assessed as having a complete response, partial response, or stable disease
Measured: through study completion, an average of 1 year
Overall survival (OS)
Patients were enrolled until their death from any cause
Measured: Through study completion, an average of 1year
Security
Safety was evaluated by adverse reactions
Measured: Through study completion, an average of 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start20 Oct 2023
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Nanchang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaodong Peng, Director, Study chair, The First Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118762
- Sponsor's protocol ID
- HMPL-013-E1-C002
- Status last verified
- Nov 2023
- First submitted
- 26 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open, Multicenter Clinical Study of Fruquintinib Combined With Raltitrexed in the Treatment of Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06118762
- Acronym / sponsor ID
- HMPL-013-E1-C002
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- metastatic colorectal cancer, Fruquintinib, Raltitrexed
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 7 Nov 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 evaluate the efficacy and safety of Fruquintinib combined with Raltitrexed in the treatment of metastatic colorectal cancer that progressed or could not be tolerated after previous fluorouracil, oxaliplatin, and irinotecan based therapy
Detailed description
To evaluate the progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety of Fruquintinib combined with Raltitrexed in 30 patients with metastatic colorectal cancer who had progressed or could not tolerate fluorouracil, oxaliplatin, and irinotecan based therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fruquintinib combined with Raltitrexed group | Experimental | Drug: FruquintinibFruquintinib combined with Raltitrexed therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Have fully understood the study and voluntarily signed the informed consent;
- Age ≥18 years old, gender unlimited;
- Advanced metastatic colorectal adenocarcinoma confirmed by histopathology;
- The patient progressed or was intolerant after receiving at least previous standard therapy containing fluorouracil, oxaliplatin, and irinotecan.
- Have at least one measurable lesion (RECIST 1.1 standard);
Key exclusion criteria (16 listed)
- Previous treatment with Fruquintinib or other anti-vascular endothelial growth factor receptor (VEGFR) inhibitors such as Apatinib, Regorafenib, and Anlotinib;
- Previous treatment with Raltitrexed;
- Participated in other drug clinical trials and received at least one drug therapy within four weeks prior to enrollment or received other systemic anti-tumor therapy, including chemotherapy, signal transduction inhibitors, hormone therapy, and immunotherapy within four weeks prior to enrollment;
- The patient currently has a disease or condition that affects drug absorption, or the patient cannot take Fruquintinib orally;
- The patient currently has gastrointestinal diseases such as gastric and duodenal active ulcers, ulcerative colitis, or active bleeding from unresectable tumors, or other conditions determined by researchers that may cause gastrointestinal bleeding or perforation;
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: RaltitrexedFruquintinib capsule is taken orally once a day, 5 mg each time, and taken for 2 weeks and stopped for 1 week, every 21 days (3 weeks) for a cycle. Raltitrexed: 3 mg/m2 intravenously, on the first day of each cycle, for a treatment cycle of 3 weeks. Combination treatment until toxicity becomes intolerable, disease progression, or death. | Drug | Fruquintinib combined with Raltitrexed group |
Primary outcome
Progression free survival (PFS)
Time frame: From date of randomization until the date of first documented progression or date of death
The time from enrollment to disease progression or death
4 secondary outcomes
Objective response rate (ORR)
Time frame: through study completion, an average of 1 year
Disease control rate (DCR)
Time frame: through study completion, an average of 1 year
Overall survival (OS)
Time frame: Through study completion, an average of 1year
Security
Time frame: Through study completion, an average of 1year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 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.
Xiaodong Peng, Director study chair
The First Affiliated Hospital of Nanchang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fruquintinib in people with Metastatic Colorectal Cancer, run by The First Affiliated Hospital of Nanchang 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 19 inclusion and 16 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 7 Nov 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Xiaodong Peng, Director (0086-457-079186427246, pxddhbb@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: From date of randomization until the date of first documented progression or date of death). 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 7 Nov 2023.