Using fruquintinib with TAS-102 for advanced colorectal cancer treatment

A Real-world Study of Fruquintinib in the Cross-line Treatment of Refractory mCRC

This study is testing if combining two cancer drugs, fruquintinib and TAS-102, can help people with advanced colorectal cancer who haven't had success with other treatments.

Quick facts

• Study type: Observational
• Enrollment: 36 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Wuhan Union Hospital, China (Academic / other)
• Drugs / interventions: fruquinitinib, fruquintinib
• Locations: 3 sites (Wuhan, Hubei and 2 other locations)
• Trial ID: NCT06099314 on ClinicalTrials.gov

What this trial studies

This observational study focuses on patients with metastatic colorectal cancer who have not responded to previous treatments. After progressing on third-line therapy with fruquintinib and PD-1 inhibitors, participants will receive a fourth-line treatment combining fruquintinib with TAS-102. The primary goal is to observe the overall survival rates of this cross-line treatment approach. The study aims to explore the efficacy and safety of reintroducing fruquintinib in combination with TAS-102 after prior treatment failure.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with metastatic colorectal cancer who have previously undergone specific lines of therapy and have measurable lesions.

Not a fit: Patients who have contraindications to the study drugs or are allergic to them will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for patients with refractory metastatic colorectal cancer.

How similar studies have performed: While this approach is relatively novel, similar studies exploring cross-line treatments have shown promise in other contexts.

Eligibility criteria

Inclusion Criteria:

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To be enrolled in this study, patients must meet all of the following criteria:

1. Age ≥18 years, ≤75 years;
2. No gender limitation;
3. Patients with metastatic colorectal cancer confirmed by histopathology had previously received 2-line system therapy with fluorouracil, oxaliplatin, irinotecan, anti-VEGF, anti-EGFR (RAS and BRAF wild type) (treatment with anti-VEGF-TKI is not allowed), and had received fruquinitinib combined with PD-1 inhibitors for third-line treatment. After progression (PD) (confirmed by RECIST 1.1 ), fruquinitinib combined with TAS-102 as fourth-line therapy was received.
4. Expected survival ≥12 weeks
5. Must have at least one measurable lesion (RECIST1.1).
6. Full organ and bone marrow function.

Exclusion Criteria:

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Patients will not be admitted to the study if they meet any of the following criteria:

1. Patients with contraindications to study drugs (fruquinitinib, PD-1 inhibitor, TAS-102);
2. allergic to the investigational drug or any of its adjuncts;
3. There are other non-investigational drugs during third-line and fourth-line treatment;
4. Pregnant or lactating female subjects;
5. Patients with a large number of pleural effusion or ascites requiring drainage;
6. Patients considered unsuitable for inclusion in this study by the investigators.

Where this trial is running

Wuhan, Hubei and 2 other locations

• TONGJI Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)

Study contacts

• Principal investigator: Zhenyu Lin — Wuhan Union Hospital, China
• Study coordinator: Zhenyu Lin

Conditions Fruquintinib; Metastatic Colorectal Cancer