Can a targeted drug boost chemotherapy in advanced colorectal cancer?
NCT ID NCT05004441
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Researchers are testing whether adding fruquintinib to standard chemotherapy (mFOLFOX6 or FOLFIRI) helps people with metastatic colorectal cancer who have not yet received treatment for advanced disease. The trial enrolls adults up to age 75 with confirmed metastatic colorectal cancer and specific tumor genetics. Participants receive daily fruquintinib pills plus chemotherapy, and researchers measure how many tumors shrink and how long patients live without their cancer worsening.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fruquintinib, a targeted cancer drug, added to standard chemotherapy (mFOLFOX6 or FOLFIRI)
- What this could lead to
- If it works, this could offer a new first-line option that shrinks tumors more effectively for people with metastatic colorectal cancer.
- What could go wrong
- This is a small, early-stage trial, so the results may not hold up in larger studies. Adding fruquintinib to chemotherapy could also increase side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
43 people
The number who actually took part.
- Started
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Jul 2021
- Finished
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Nov 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 years, ≤75 years 2. Histologically confirmed unresectable or metastatic stage colorectal cancer 3. Known RAS activating mutation/wild type and BRAF wild type; 4. Patients have not received systematic treatment for unresectable or metastatic colorectal cancer (those who have received adjuvant or neoadjuvant chemotherapy with one regimen and relapsed more than 12 months after the end of chemotherapy can be enrolled); 5. At least one measurable disease according to RECIST 1.1 guidelines for solid tumors; 6. BMI≥18; 7. ECOG 0-1 8. Life expectancy \> 12 weeks 9. Patients must have adequate organ function 10. Women of childbearing age must have a negative pregnancy test within the first day of the study, and contraceptive methods should be taken during the study until 6 months after the last administration; 11. Informed consent has been signed. Exclusion Criteria: 1. Have received other systemic anti-tumor therapies within 2 weeks before recruited(eg.chemotherapy or radiotherapy, immunotherapy, biological or hormonal therapy, or any VEGFR inhibitor treatment); 2. Known BRAF activating mutation 3. systolic blood pressure \> 140mmHg or diastolic blood pressure \> 90mmHg regardless of any antihypertensive drugs; Or patients need more than two antihypertensive drugs; 4. Clinically significant electrolyte abnormality; 5. Proteinuria ≥ 2+ (1.0g/24hr); 6. Patients have untreated central nervous system metastasis; 7. Patients have not recovered from all toxicities associated with prior anti-tumor therapy ,to acceptable baseline status, or a National Cancer Institute Common Terminology Criteria for Adverse Events(NCI CTCAE v5.0) Grade of 0 or 1, except for alopecia and oxaliplatin induced neurotoxicity ≤ 2 , and the previous surgery did not recover completely; 8. Have received other systemic anti-tumor therapies within 4 weeks before recruited; 9. Clinical uncontrolled active infections, such as acute pneumonia and active hepatitis B / C (previous history of hepatitis B virus infection, whether drug controlled or not, HBV DNA ≥ 104) × Copy number or ≥ 2000 IU / ml); 10. Dysphagia or known malabsorption of drugs; 11. Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in GI; 12. Have evidence or history of bleeding tendency within 2 months after enrollment, the researcher assessed that moderate or severe bleeding tendency was not suitable for enrollment; 13. Stroke (including transient ischemic attack) occurred within 12 months before admission; 14. Patients had other malignant tumors in the past 5 years or at the same time (except for the cured skin basal cell carcinoma and cervical carcinoma in situ); 15. Pregnant or lactating women; 16. Allergic to fruquintinib; 17. History of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or organ transplantation; 18. Patients with acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before admission; Or a history of arterial thrombosis or deep venous thrombosis; 19. There are concomitant diseases (such as severe hypertension, diabetes, thyroid disease, active infection, etc.) that seriously endanger the safety of patients or affect the completion of the study, or any laboratory abnormalities that are not suitable for participating in the clinical trial according to the judgment of the researcher, 20. Serious psychological or mental disorders that may affect the compliance study; 21. Participating in other drug clinical trials within 4 weeks before recruited.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Zhongnan Hopital of Wuhan University
Wuhan, Hubei, 430071, China
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Other studies related to the condition(s) this trial covers.
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