Disitamab Vedotin Combined With Fruquintinib for mCRC With HER2 Expression (NCT05661357) | Clinical Trial Compass
UnknownPhase 4
Disitamab Vedotin Combined With Fruquintinib for mCRC With HER2 Expression
China51 participantsStarted 2023-01-01
Plain-language summary
Single arm, prospective, exploratory clinical study of Disitamab Vedotin combined with Fruquintinib for advanced colorectal cancer with HER2 expression or mutation that has received at least two standard treatment failures
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Colorectal cancer patients aged ≥ 18 years and ≤ 75 years;
✓. ECOG score 0-1;
✓. Patients with advanced colorectal cancer who are pathologically diagnosed as HER2 expression or mutation and who fail or are intolerant after second-line treatment; Note: HER2 expression refers to patients with tumor cell immunohistochemical staining intensity of 1+, 2+or 3+confirmed to have expression at least once in the pathological detection/review of primary or metastatic lesions conducted by the pathology department of our hospital, or patients with advanced colorectal cancer with HER2 gene amplification or mutation confirmed by NGS.
✓. According to RECIST 1.1 standard, there is at least one measurable target lesion, and tumor imaging evaluation is conducted within 28 days before the first drug use;
✓. Estimated survival time ≥ 12 weeks;
✓. If the main organs function normally, they meet the following standards:
Exclusion criteria
✕. Have received anti-tumor treatment or radiotherapy for any malignant tumor in the past;
✕. At the same time, they received anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphate therapy or immunotherapy;
✕. The patient has undergone major surgery unrelated to colorectal cancer within 4 weeks before enrollment, or the patient has not fully recovered from such surgery;
✕. Serious heart disease or discomfort, including but not limited to the following diseases:
What they're measuring
1
ORR
Timeframe: through study completion, an average of 2 years
✕. Inability to swallow, intestinal obstruction or other factors affecting drug administration and absorption;
✕. People known to have a history of allergy to the drug components of this protocol; Have a history of immunodeficiency, including HIV test positive, HBV/HCV test positive, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;
✕. Women in pregnancy and lactation, women with fertility and positive baseline pregnancy test, or women in childbearing age who are unwilling to take effective contraceptive measures during the whole trial period and within 7 months after the last study drug use;
✕. Suffer from serious concomitant diseases or other concomitant diseases that may interfere with the planned treatment, or The investigator believes that the patient is not suitable to participate in any other situation of this study.