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 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT05124002
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years, male or female
* Histologically or cytologically confirmed intrahepatic mass-forming cholangiocarcinoma (IMCC) with unresectable lesion(s) or patients who refuse surgery
* At least one measurable lesion according RECIST v1.1 criteria \[spiral CT/MRI scan ≥ 10 mm (CT scan slice thickness no greater than 5 mm)\]
* Life expectancy ≥ 3 months
* The function of vital organs meets the following requirements: absolute neutrophil count (ANC) ≥ 3.5 × 10\^9/L; platelets ≥ 125 × 10\^9/L; hemoglobin ≥ 8 g/dL; Serum albumin ≥ 2.8 g/dL; bilirubin ≤ 3 ULN, ALT/AST ≤ 2.5 ULN; ALT/AST in the presence of liver metastases ≤ 5 ULN; creatinine ≤ 1.5 ULN; euthyroid; LVEF \> 50%
* The date of the first dose of study drug is ≥ 21 days from the date of previous anti-tumor treatment, and has recovered from adverse reactions to prior anti-tumor therapy to baseline or lower than grade 1 (according to CTCAE Version 5.0)(except alopecia)
* Female patients of childbearing potential (including early menopause, menopause \< 2 years, and non-surgical sterilization), male patients and their partners must agree to use effective contraceptive measures during the study
* Patients or their legal representatives can understand and offer informed consent, being willing to take part in the follow-up with good compliance
Exclusion Criteria:
* Pregnant or lactating women, men or women who are reluctant to take effective contraceptive measures
* Previous treatment with oncolytic viruses (such as T-VEC)
* Abnormal coagulation function, or having a bleeding tendency, or receiving thrombolytic or anticoagulant therapy
* Patients with poor glycemic control
* Known central nervous system tumors, including metastatic brain tumors
* Accompanied by any unstable systemic diseases, including but not limited to severe infection, resistant hypertension, unstable angina, stroke or myocardial infarction within 6 months, congestive heart failure, and serious cardiac arrhythmia requiring medication, renal or metabolic disease requiring medication
* Known hypersensitivity to the study drug or oxaliplatin, leucovorin calcium, fluorouracil
* History of immunodeficiency or autoimmune disease, or receiving long-term systemic steroid therapy within 7 days before enrollment, or any form of immunosuppressive therapy
* Other conditions that are not suitable for participating in this trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05124002
Study Brief:
Protocol Section:
NCT05124002