Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT07047560
Eligibility Criteria:
Inclusion Criteria:
1. Signed the informed consent；
2. Male or female patients ≥18 years old;
3. ECOG physical status score is 0 or 1;
4. Patients with pathologically confirmed advanced colorectal carcinoma (all other histological types excluded);
5. Patients who experienced disease progression under either of the following circumstances:During or within 6 months after first-line oxaliplatin-containing chemotherapy, or within 1 year after completing oxaliplatin-based adjuvant chemotherapy post-resection;
6. Expected survival time ≥ 3 months;
7. Patients must have at least one measurable metastatic lesion according to RECIST version 1.1;
8. Normal organ function:
1. Hematology :Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (1500/mm3); Platelet count ≥ 100 × 109/L (100000/mm3); Hemoglobin ≥ 90g/L;
2. Kidney:The calculated value of creatinine clearance rate (CrCl) is ≥ 50 mL/min; Normal urine routine, urine protein\<2+or 24-hour (h) urine protein quantification\<1.0 g;
3. Liver:Total serum bilirubin (TBiL) ≤ 1.5 × ULN;AST and ALT ≤ 2.5 × ULN; For subjects with liver metastasis, AST and ALT can be ≤ 5 × ULN;Serum albumin (ALB) ≥ 30g/L;
4. Normal coagulation function, international standardized ratio (INR) ≤ 1.5 x ULN, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 x ULN;
9. Women of childbearing age must undergo a pregnancy test (serum or urine) with a negative result within 14 days before enrollment, and voluntarily use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of the study drug; For males, surgical sterilization or agreement to use appropriate methods of contraception during observation and within 8 weeks after the last administration of study medication should be considered;
10. Comply with the scheduled visits, treatment plans, laboratory tests, and other requirements of the study;
Exclusion Criteria:
1. History of other malignancies (except cured basal cell carcinoma or cervical carcinoma in situ);
2. Participation in other drug trials within 4 weeks prior to enrollment;
3. Uncontrolled hypertension (SBP \>160 mmHg or DBP \>100 mmHg);
4. Acute coronary syndrome (including MI/unstable angina) with coronary angioplasty/stent placement within 6 months;
5. NYHA class II+ heart failure, unstable angina, MI, or severe arrhythmia with cardiovascular impairment within 6 months;
6. Symptomatic brain metastases;
7. Severe comorbidities requiring hospitalization (e.g., ileus, bowel obstruction, pulmonary fibrosis, refractory diabetes, heart/kidney/liver failure, psychiatric/cerebrovascular disorders);
8. Gastrointestinal perforation/fistula, intra-abdominal abscess, or non-GI fistula within 6 months;
9. Concomitant use of strong CYP3A4/CYP2C8 inhibitors/inducers or UGT1A1 inhibitors within 2 weeks;
10. Pregnancy or lactation;
11. Other investigator-determined contraindications.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07047560
Study Brief:
Protocol Section:
NCT07047560