Fruquintinib plus anti-EGFR antibody for third-line metastatic colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional trial evaluates the combination of an oral anti-angiogenesis drug, fruquintinib, with an anti-EGFR antibody, cetuximab-beta, in patients with RAS wild-type metastatic colorectal cancer who have progressed after standard therapies. Enrolling up to 46 participants, the study administers fruquintinib daily in a 3 weeks on/1 week off schedule alongside cetuximab-beta to assess safety and preliminary efficacy. Eligible patients typically have measurable disease, good performance status, and prior exposure to fluoropyrimidine, oxaliplatin, and irinotecan, with tumor genetics confirmed as wild-type for KRAS, NRAS, and BRAF. The trial aims to determine whether this dual-targeted approach can provide additional clinical benefit compared with current third-line options. Results will inform feasibility and signal whether to pursue larger confirmatory studies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18-75 years, inclusive.
2. Fully informed about the study and willing to sign written informed consent.
3. Histologically confirmed metastatic or advanced colorectal adenocarcinoma.
4. Tumor confirmed as NRAS, KRAS, and BRAF wild-type.
5. At least one measurable lesion according to RECIST 1.1 criteria.
6. ECOG performance status of 0-1.
7. Estimated life expectancy ≥ 12 weeks.
8. Prior treatment with oxaliplatin- and irinotecan-based therapy, or failure of at least two prior standard regimens.
9. Prior treatments must have included fluoropyrimidine, oxaliplatin, and irinotecan (with or without bevacizumab or cetuximab).
10. Treatment failure defined as disease progression during therapy or within 3 months after last treatment, or intolerance to toxicity.
11. Recurrence within 6 months after adjuvant/neoadjuvant therapy is considered as first-line failure.
12. Adequate organ function within 7 days prior to enrollment:

    * ANC ≥ 1.5 × 10⁹/L
    * Platelets ≥ 80 × 10⁹/L
    * Hemoglobin ≥ 8 g/dL
    * Total bilirubin ≤ 1.5 × ULN
    * AST/ALT ≤ 2.5 × ULN (≤ 5 × ULN in liver metastasis)
    * Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min
    * INR ≤ 1.5 or APTT ≤ 1.5 × ULN
13. No receipt of blood products or growth factors within 14 days prior to enrollment.
14. Able and willing to comply with study procedures and follow-up.

Exclusion Criteria:

1. Unable or unwilling to comply with the study protocol.
2. Prior treatment with VEGFR tyrosine kinase inhibitors (e.g., regorafenib).
3. Participation in another clinical trial within 4 weeks.
4. Systemic anticancer therapy within 4 weeks before enrollment.
5. Uncontrolled hypertension (SBP \> 140 mmHg or DBP \> 90 mmHg).
6. Any condition that affects drug absorption or inability to take oral medication.
7. Active gastric or duodenal ulcer, ulcerative colitis, or tumor-related active bleeding.
8. Positive fecal occult blood (≥ ++) without endoscopic exclusion of bleeding.
9. Arterial or deep venous thrombosis within 6 months.
10. Significant bleeding within 2 months (melena, hematemesis, hemoptysis).
11. Stroke or transient ischemic attack within 12 months.
12. Significant cardiovascular disease:

    * Acute myocardial infarction within 6 months
    * Severe or unstable angina
    * Heart failure NYHA class \> II
    * Clinically significant arrhythmia requiring treatment
    * LVEF \< 50%
13. History of other malignancies within 5 years (except adequately treated in-situ cancers or early non-invasive cancers).
14. Uncontrolled active infection, including HBV or HCV (HBV DNA ≥ 1×10⁴ copies/mL or \>2000 IU/mL).
15. Pregnant or breastfeeding women.
16. Urine protein ≥ 2+ or 24-hour urine protein \> 1.0 g.
17. HIV-positive individuals.
18. Any condition that, in the investigator's judgment, makes the patient unsuitable for the study.

Where it's running

• National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Yongkun Sun — National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
• Study coordinator: Yongkun Sun
• Email: hsunyk@cicams.ac.cn
• Phone: (+86)010-87788800

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Prognostic Factors for Fruquintinib in Metastatic Colorectal Cancer

  This cohort study tests how clinical and biological factors relate to survival outcomes in adults with metastatic colorectal cancer treated with fruquintinib.

  Recruiting at 83 sites Federation Francophone de Cancerologie Digestive · Poitiers, France and 82 other locations · NCT07124858

• 5‑Fluorouracil–based chemotherapy plus fruquintinib for advanced or metastatic colorectal cancer

  This phase II test will combine 5‑FU–based chemotherapy with the oral drug fruquintinib as a first-line treatment for adults with locally advanced unresectable or metastatic colorectal cancer.

  Recruiting Phase 2 The Methodist Hospital Research Institute · Houston, Texas · NCT07042685

• Candonilimab with Fruquintinib and Paclitaxel Albumin-Bound as second-line treatment for advanced gastric cancer

  This phase 2 trial tests whether adding candonilimab to fruquintinib and nab-paclitaxel helps people with advanced gastric or gastroesophageal junction cancer who progressed after first-line therapy.

  Recruiting Phase 2 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07920224

• KRAS Inhibitor ETX-929 in advanced solid tumors

  This trial tests ETX-929, alone or with cetuximab, in people whose cancers have KRAS mutations and have progressed after prior therapy.

  Recruiting Phase 1/2 Ensem Therapeutics · Fairfax, Virginia · NCT07912593

• Ivarmacitinib with Camrelizumab and Fruquintinib in advanced colorectal cancer after prior therapies

  This trial tests whether combining ivarmacitinib with camrelizumab and fruquintinib can help patients with metastatic colorectal cancer who have progressed after multiple treatments.

  Recruiting Phase 2 Renmin Hospital of Wuhan University · Wuhan, Hubei · NCT07896096

• Neoadjuvant therapy for locally advanced low rectal cancer: adding fruquintinib to short-course radiotherapy with tislelizumab and CAPOX

  This study tests whether adding fruquintinib to short-course radiotherapy plus tislelizumab and CAPOX before surgery helps people with locally advanced low rectal cancer achieve a better tumor response.

  Recruiting Phase 2 Ruijin Hospital · Shanghai, Shanghai Municipality · NCT07888309

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.