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 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT06259058
Eligibility Criteria:
Inclusion Criteria:
* Age: ≥18 years old.
* Histologically or cytologically proven pancreatic ductal adenocarcinoma.
* Multidisciplinary assessment as borderline resectable disease.
* At least one measurable lesion (according to RECIST v1.1).
* No prior antitumor therapy for pancreatic cancer.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 \~ 1.
* The expected survival time ≥3 months.
* Adequate bone marrow function as evidenced by: 1) Absolute neutrophil count (ANC) ≥1.5×10\^9/L, 2) Platelet count ≥100×10\^9/L, 3) Hemoglobin (Hb) ≥90 g/L, 4) White blood cell (WBC) ≥3.0×10\^9/L.
* Adequate hepatic function as evidenced by: 1) Serum total bilirubin ≤1.5 × upper limit of normal (ULN), 2) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN
* Adequate renal function as evidenced by serum creatinine (Cr)≤1.5 × ULN or creatinine clearance ≥60 mL/min.
* Agree and be able to comply with the plan during the study period. Provide written informed consent before entering the study screening.
Exclusion Criteria:
* Any other malignancy within 5 years, with the exception of cured in-situ carcinoma or basal cell carcinoma etc.
* Patients with distant metastases and/or cannot complete resection.
* Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment.
* Active HIV, HBV, HCV infection.
* Combined with uncontrollable systemic diseases.
* Presence of severe gastrointestinal disease (including active bleeding, \> grade 1 obstruction \[CTCAE v5.0\], or \> grade 1 diarrhea \[CTCAE v5.0\]).
* History of allergy or hypersensitivity to drug or any of their excipients.
* Patients who have chemotherapy and surgery contraindications.
* Documented serum albumin ≤3 g/dL
* Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1 within 14 days before the first administration.
* Pregnant or breastfeeding women, or subjects of childbearing age who refuse contraception.
* Participated in other trial within 30 days before the first administration.
* Patients who are not suitable to participate in this trial for any reason judged by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06259058
Study Brief:
Protocol Section:
NCT06259058