Fruquintinib + Chemotherapy for Colorectal Cancer

Overseen By Titilayo Olubajo

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: The Methodist Hospital Research Institute

Must not be taking: Corticosteroids, Immunosuppressants, others

Disqualifiers: Cardiac issues, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new treatment can help people with advanced colorectal cancer that cannot be surgically removed or has spread. Researchers are combining a new drug, fruquintinib (a type of targeted therapy), with standard chemotherapy to determine if this combination can slow cancer growth and is safe to use. This study targets individuals who have not previously received chemotherapy and have colorectal cancer that cannot be surgically removed or has metastasized. If successful, this trial could lead to a new treatment option for colorectal cancer. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to potential advancements in colorectal cancer treatment.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, if you are on chronic corticosteroids or other systemic immunosuppressive agents, you may not be eligible. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatment is likely to be safe?

Research has shown that fruquintinib, when combined with the best supportive care, offers a predictable and manageable safety profile for patients with advanced colorectal cancer. In studies, fruquintinib was used alongside chemotherapy and demonstrated safety, with expected and manageable side effects. Most patients tolerated the treatment well.

Common side effects included fatigue, nausea, and diarrhea, typically mild to moderate. More serious side effects occurred less frequently, indicating that while some side effects might arise, they are usually not severe. Researchers closely monitor patients to address any issues.

Overall, existing data suggests that fruquintinib is generally well-tolerated, making it a promising option for patients considering joining a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for colorectal cancer?

Unlike the standard treatments for colorectal cancer, which typically include chemotherapy regimens like FOLFIRI or FOLFOX, fruquintinib offers a novel approach by specifically targeting tumor blood vessels. Fruquintinib is a small molecule inhibitor that blocks vascular endothelial growth factor receptors (VEGFR), which are crucial for blood vessel growth in tumors. This targeted action can potentially improve the effectiveness of chemotherapy by cutting off the tumor's blood supply, starving it of nutrients needed for growth. Researchers are excited about fruquintinib because it could enhance the impact of existing chemotherapy regimens, potentially leading to better outcomes for patients.

What evidence suggests that this treatment might be an effective treatment for colorectal cancer?

Research has shown that fruquintinib can extend the lives of people with colorectal cancer. Studies have found that it improves both overall survival and progression-free survival compared to a placebo in those with metastatic colorectal cancer (mCRC). Real-world evidence suggests that fruquintinib is effective when used earlier in treatment. It generally causes manageable side effects. In this trial, all participants will receive fruquintinib combined with standard 5FU-based chemotherapy, which could offer a promising option for those with advanced colorectal cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Maen Abdelrahim, MD, PhD, Pharm D

Principal Investigator

The Methodist Hospital Research Institute

Abdullah Esmail, MD

Principal Investigator

Houston Methodist Neal Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with advanced colorectal cancer that can't be removed by surgery or has spread. Participants should not have had prior treatment for metastatic disease and must be able to take oral medication. They need normal organ function and no history of significant heart disease, bleeding disorders, or other cancers.

Inclusion Criteria

Measurable disease per RECISTv1.1

I am 18 years old or older.

Patients of childbearing potential must agree to use an adequate method of contraception during the study and for 30 days after the last dose of study treatment

Exclusion Criteria

I have had ongoing constipation or a blockage in my bowel in the last 6 months.

I am unable to give consent for medical procedures.

Serum creatinine or serum urea >1.5 × ULN

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 5FU-based chemotherapy in combination with fruquintinib in 28-day cycles

6 months

Monthly visits for each cycle

Maintenance

Participants with stable disease or better transition to maintenance therapy with 5FU and fruquintinib

Until disease progression or unacceptable toxicity

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Fruquintinib

Trial Overview The study tests a combination of fruquintinib with standard chemotherapy (FOLFIRI or mFOLFOX6) in cycles lasting 28 days. If the disease doesn't worsen after six months, patients move to a maintenance phase with just 5FU and fruquintinib until the cancer progresses or side effects become too severe.

How Is the Trial Designed?

Group I: 5FU-based chemotherapy (FOLFIRI or mFOLFOX6) with fruquintinib Experimental Treatment 1 Intervention

The trial includes a single treatment arm in which all enrolled patients receive a combination of 5-Fluorouracil (5FU)-based chemotherapy and fruquintinib. Patients are treated with either the FOLFIRI or mFOLFOX6 (FOLFIRI: folinic acid, 5FU, irinotecan; or mFOLFOX6: folinic acid, 5FU, oxaliplatin) regimen, both of which include 5-fluorouracil (5FU), leucovorin (LV), and either irinotecan or oxaliplatin, respectively. Fruquintinib is administered orally once daily for 21 days of each 28-day cycle. The initial three patients receive 4 mg of fruquintinib daily to assess safety; if no dose-limiting toxicities are observed, the dose is increased to 5 mg for subsequent patients. Treatment continues until disease progression, unacceptable toxicity, or patient withdrawal. After six months, patients with stable disease or better transition to a maintenance phase with 5FU and fruquintinib alone.

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

Takeda Development Center Americas, Inc.

Industry Sponsor

Trials

58

Recruited

10,800+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11859084/

Clinical Progress of Fruquintinib in Colorectal Cancer According to a systematic review and meta-analysis, the one-, three-, and five-year survival rates of CRC patients were 79%, 72%, and 62%, ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e23317

Real-world evidence of fruquintinib (Fruq) efficacy after ... The data suggest flexibility in treatment choices, with Fruquintinib showing improved OS when used earlier in the treatment sequence. These ...

3. onclive.com onclive.com/view/real-world-analysis-sheds-light-on-fruquintinib-use-in-later-line-metastatic-crc

Real-World Analysis Sheds Light on Fruquintinib Use in ... A real-world study in Portugal showed fruquintinib displayed a manageable safety profile and an efficacy trend in refractory colorectal cancer.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0959804925000498

Health-related quality of life associated with fruquintinib in ... Fruquintinib improved median TTD vs placebo in some QLQ-C30 subscales and ED-5D VAS. TTD to ECOG PS ≥2 or death was delayed with fruquintinib vs placebo.

5. esmogastro.org esmogastro.org/article/S2949-8198(25)00074-3/fulltext

Analysis of fruquintinib in patients with metastatic colorectal ... Fruquintinib improved OS and PFS versus placebo in patients with refractory mCRC. ... Grade ≥3 TEAEs occurred in 60% versus 47% of patients ( ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40163688/

Fruquintinib versus placebo in patients with refractory ... Conclusion: Fruquintinib + BSC demonstrated a predictable and manageable safety profile in pretreated patients with mCRC and is a novel oral ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.3571

Efficacy and safety of fruquintinib plus investigator's choice ... Efficacy and safety of fruquintinib plus investigator's choice of chemotherapy as second-line therapy in metastatic colorectal cancer: Updated ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0273230025002053

Real-World Safety of Fruquininib in Refractory metastatic ... The results provide critical safety information for clinicians managing refractory metastatic colorectal cancer with fruquintinib, supporting ...

9. esmoopen.com esmoopen.com/article/S2059-7029(24)01471-6/fulltext

Fruquintinib in refractory metastatic colorectal cancer The median progression-free survival was 5.0 months and the median overall survival was 11.4 months. Of them, 387 (74.4%) were treated with ...

10. academic.oup.com academic.oup.com/oncolo/article/30/3/oyae360/8101338

Fruquintinib versus placebo in patients with refractory ... Fruquintinib + BSC demonstrated a predictable and manageable safety profile in pretreated patients with mCRC and is a novel oral treatment ...