Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sir Run Run Shaw Hospital
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. This study plans to enroll patients diagnosed with advanced colorectal cancer who are treated at Sir Run Run Shaw Hospital, Zhejiang University School of Medicine.
2. Age ≥18 years.
3. Voluntarily participate in this study and sign the informed consent form.
4. Confirmed histological evidence of colon or rectal adenocarcinoma.
5. ECOG performance status score of 0-1.
6. Tumor SULF1 high expression confirmed by immunohistochemistry.
7. Distant metastasis or unresectable locally advanced colon or rectal adenocarcinoma confirmed by CT or MR evaluation, and according to RECIST v1.1 criteria, at least one measurable lesion confirmed by independent central imaging review, and after multidisciplinary discussion, it is considered that local treatment (surgery, intervention, radiotherapy, etc.) will not be performed currently or in the near future (within 2 months).
8. Patients with metastatic colorectal cancer who have received at least two prior lines of standard regimen therapy, including fluorouracil, oxaliplatin, and irinotecan.
9. The following laboratory test values obtained within 7 days before treatment on Day 1 of each treatment cycle, with adequate organ function:
Hemoglobin ≥90 g/L, neutrophil count ≥1.5×10⁹/L, platelet count ≥75×10⁹/L, serum total bilirubin ≤1.5× upper limit of normal (ULN), aspartate aminotransferase ≤2×ULN, alanine aminotransferase ≤3×ULN, serum creatinine ≤1.5×ULN.
10. Willing and able to comply with the study protocol and visit schedule.
11. Expected survival of at least 12 weeks.
You may not be if
1）Patients with severe infection, obstruction, active bleeding, or perforation requiring emergency surgery or stent placement.
2）History of prior or concurrent other active malignancies (except malignancies that have been curatively treated with no recurrence for more than 5 years, or carcinoma in situ that can be cured with adequate treatment).
3）Major surgery such as laparotomy, thoracotomy, or laparoscopic organ resection, or severe trauma within the previous 2 weeks.
4）Active coronary artery disease, severe/unstable angina, or newly diagnosed angina or myocardial infarction within 12 months before study enrollment.
5）Thrombotic or embolic events within the previous 6 months, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, or deep vein thrombosis.
6）New York Heart Association (NYHA) class II or higher congestive heart failure.
7）Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related disease, or active hepatitis B or hepatitis C.
8）Active inflammatory bowel disease or other colorectal diseases causing chronic diarrhea.
9）Any unresolved CTCAE grade 2 or higher toxicity caused by prior treatment (except anemia, alopecia, and skin pigmentation).
10）Known or suspected history of allergy to any relevant drug used in the study.
11）Patients scheduled to undergo local treatment (surgery, intervention, radiotherapy, etc.) in the near future (within 2 months).
12）Any medical condition that is unstable or may affect patient safety and study compliance.
13）Radiotherapy within \<4 weeks before the first dose of study drug, or chemotherapy, biological therapy, endocrine therapy, or small-molecule targeted therapy before the first dose of study drug (enrollment allowed if washout ≥5 half-lives from the first dose of study drug).
14）Insufficient hematopoietic function or organ function (correction with blood products such as transfusion within ≤14 days before the first dose of study drug is not allowed).
15）Vulnerable populations, including individuals with mental illness, cognitive impairment, critically ill patients, minors, pregnant women, illiterate individuals, etc.
