New combo may offer better option for Hard-to-Treat colorectal cancer
NCT ID NCT07362836
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a new drug combination (fruquintinib plus chemotherapy) works better than the current standard (bevacizumab plus chemotherapy) for people with a specific type of advanced colorectal cancer that has a RAS mutation. About 224 adults aged 18 to 75 will be randomly assigned to one of the two treatments. The main goal is to see how long patients live without their cancer getting worse.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 224 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2030
An estimate. End dates often move.
- 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
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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. Patients voluntarily participate in the study, sign the informed consent form, and have good compliance. 2. 18 years ≤ age ≤ 75 years. 3. Histologically and/or cytologically confirmed unresectable metastatic colorectal cancer. 4. RAS mutant type. 5. Previously received chemotherapy based on fluoropyrimidines (5-fluorouracil or capecitabine, etc.), oxaliplatin or irinotecan; previous adjuvant/neoadjuvant therapy is allowed. If recurrence or metastasis occurs during or within 6 months after adjuvant/neoadjuvant therapy, it is considered as the failure of first-line systemic chemotherapy for advanced disease. 6. Patients must have at least one measurable lesion (RECIST 1.1). 7. ECOG performance status 0-1. 8. Expected survival ≥ 12 weeks. 9. Blood tests (without blood transfusion within 14 days) 1) Absolute neutrophil count ≥ 1.5×10\^9/L, platelet count ≥ 100×10\^9/L, hemoglobin concentration ≥ 9g/dL; 2) Liver function tests (AST and ALT ≤ 2.5×ULN, bilirubin ≤ 1.5×ULN; if there is liver metastasis, AST and ALT ≤ 5×ULN); 3) Renal function (serum creatinine (Cr) ≤ 1.5×ULN, or creatinine clearance rate (CCr) ≥ 60ml/min); 4) Coagulation, international normalized ratio (INR) ≤ 1.5×ULN, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5×ULN; 5) Thyroid function, thyroid stimulating hormone (TSH) ≤ upper limit of normal (ULN); if abnormal, FT3 and FT4 levels should be examined, and patients with normal FT3 and FT4 levels can be included. 10. Women of childbearing age are willing to use medically approved effective contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study and for 3 months after the last administration of the study drug; for male subjects whose partners are of childbearing age, it is recommended to take effective contraceptive measures during the study and for 3 months after the last administration of the study drug. Exclusion Criteria: 1. Enrolled in another clinical study within the 4 weeks prior to enrollment in this study; 2. Previously received anti-angiogenic small molecule targeted drug treatment, such as fruquintinib, etc.; 3. Symptomatic brain or leptomeningeal metastases (except for those who have undergone local radiotherapy or surgery for brain metastases for more than 6 months and have stable disease control); 4. Experienced severe infection within 4 weeks prior to enrollment (e.g., requiring intravenous infusion of antibiotics, antifungal drugs, or antiviral drugs); 5. Hypertension that cannot be well controlled with antihypertensive drugs (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg); 6. Had active bleeding or coagulation disorders within 2 months prior to enrollment, had a bleeding tendency or was receiving thrombolytic therapy, and was assessed by the investigator as unsuitable for enrollment; 7. Had active heart disease within 6 months prior to treatment, including myocardial infarction, severe/unstable angina pectoris. Echocardiography showed left ventricular ejection fraction \< 50%, or had poorly controlled arrhythmia; 8. Had other malignant tumors within 5 years prior to enrollment or at the same time (except for cured basal cell carcinoma of the skin and cervical carcinoma in situ); 9. Known to be allergic to the study drug or any of its excipients; 10. Unable to take oral medication or the investigator judged that the subject had a condition that affected drug absorption; 11. Pregnant (positive pregnancy test before medication) or breastfeeding women; 12. Had active or uncontrolled severe infections 1) Known human immunodeficiency virus (HIV) infection; 2) Known history of clinically significant liver disease, including viral hepatitis \[known hepatitis B virus (HBV) carriers must be excluded from active HBV infection, i.e., HBV DNA positive (\>1×10\^4 copies/mL or \>2000 IU/mL); 3) Known hepatitis C virus (HCV) infection and HCV RNA positive (\>1×10\^3 copies/mL), or other hepatitis, liver cirrhosis; 13. Urinalysis indicated proteinuria ≥ 2+, and 24-hour urine protein quantification \> 1.0g; 14. Other situations judged by the investigator as unsuitable for inclusion in this study.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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