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 @ 4:50 AM
Ignite Modification Date:
2025-12-25 @ 4:50 AM
NCT ID:
NCT01847118
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed advanced or metastatic malignant solid tumors;
* Patients failed the standard anti-tumor therapy or don't have standard regimen;
* At least one measurable lesion;
* At least 4 weeks from the last chemotherapy, 6 weeks from mitomycin, and nitrosourea treatment. If patients received anti-tumor biological products, at least four t1/2 of washout period is needed;
* Toxicity from previous treatment has to restore to ≤ grade 1 (NCI CTC4.0);
* ECOG performance status 0-1;
* Life expectancy ≥ 3 months;
* Adequate hematologic function: ANC ≥ 1.5 × 10\^9 /L, HB ≥ 90 g /L (blood transfusion allowed), PLT ≥ 100 × 10\^9 /L;
* Adequate hepatic function: ALT ≤ 2.5 × ULN, AST ≤ 2.5 × ULN, TBIL ≤ 1.5 × ULN (patients with liver metastases ALT ≤ 5 × ULN, AST ≤ 5 × ULN, TBIL ≤ 3 × ULN);
* Adequate renal function: creatinine ≤ 1 × ULN;
* Coagulation function: INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN;
* Patients of childbearing potential (male and female) must agree to use reliable methods of contraception until at least 12 weeks after the last dose.
Exclusion Criteria:
* HCV, TP or HIV antibody positive;
* Previously received anti-VEGF protein drugs, such as bevacizumab;
* Histologically proven squamous cell lung cancer or squamous cell carcinoma of the head and neck;
* Active hepatitis B infection;
* Evidence of serious infection;
* Symptomatic brain metastases;
* Patients with proteinuria at screening (urine protein ≥ 1+);
* History of abdominal fistula, gastrointestinal perforation, abdominal abscess within 6 months prior to enrollment;
* Serious non-healing wounds, ulcers or fractures;
* Major surgery (excluding biopsy) or significant trauma within 4 weeks prior to enrollment;
* Active bleeding within 3 months prior to enrollment;
* Bleeding diathesis or coagulation disorder;
* History of arterial or venous thrombosis;
* History of myocardial infarction or stroke within 6 months prior to enrollment;
* Unstable angina, congestive heart failure, New York Heart Association (NYHA) class II heart failure, uncontrollable arrhythmia, uncontrolled hypertension (systolic blood pressure\> 150 mmHg and/or diastolic blood pressure\> 100 mmHg);
* Pregnant and lactating women;
* Known allergies to any excipient in the study drug;
* Patients with alcohol or drug dependence;
* Participation in other clinical trials within 4 weeks before enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
74 Years
Study:
NCT01847118
Study Brief:
Protocol Section:
NCT01847118