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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT03053167
Eligibility Criteria:
Inclusion Criteria:
* life expectancy of at least 3 months;
* histological and/or cytological confirmation of ACC;
* disease progression while on first-line palliative oxaliplatin \& fluoropyrimidine chemotherapy or relapse within 6 months after adjuvant oxaliplatin \& fluoropyrimidine chemotherapy;
* wash-out time of 4 weeks after the last chemotherapy infusion or radiotherapy，and observed lesions not in the radiotherapy target；
* at least one measurable objective tumor lesion by spiral CT examination, the maximum diameter ≥ 1cm（according to RECIST 1.1）；
* ECOG performance status 0-1；
* satisfactory main organ function，laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/L, neutrophil count（ANC） ≥1.5×109/L, platelet count（PLT） ≥90×109/L, Serum creatinine（CR）≤1.5 upper normal limitation (UNL)，creatinine clearance rate (CCr) ≥60ml/min, total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL);
* For women with child bearing potential, a negative serum or urine pregnancy test result should be obtained before enrollment
* written informed consent.
Exclusion Criteria:
* prior exposure to irinotecan or raltitrexed;
* chronic enteropathy on unresolved bowel obstruction;
* Pregnant or lactated women;
* previous malignant disease other than carcinoma in situ of the cervix or basal cell carcinoma of the skin;
* Concurrent administration of any other investigational drug, or have been enrolled in other clinical trial with investigational drug treatment within the 30 days of start of study treatment；
* cerebral metastases or leptomeningeal carcinomatosis;
* severe or uncompensated concomitant medical conditions.
* Unsuitable for the study or other chemotherapy determined by investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03053167
Study Brief:
Protocol Section:
NCT03053167