HAIC Combined With Donafenib and Sintilimab for Unresectable ICC (NCT05348811) | Clinical Trial Compass
CompletedPhase 2
HAIC Combined With Donafenib and Sintilimab for Unresectable ICC
China25 participantsStarted 2022-06-13
Plain-language summary
To evaluate the safety and tolerability of HAIC combined with donafenib and sintilimab in first-line treatment of unresectable ICC.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Unresectable or metastatic histologically or cytologically confirmed ICC
* No previous systemic treatment or local anti-tumor treatment other than surgery (biliary drainage is allowed), admission was allowed for more than 6 months after the end of adjuvant therapy
* Child-Pugh score ≤7
* Life expectancy ≥ 3 months
* At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST)1.1 criteria
* Eastern Cooperative Oncology Group(ECOG) performance status (PS) ≤ 1
* The functional indicators of important organs meet the following requirements:
* Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1.5\*10\^9 /L; platelet (PLT) ≥ 80 \*10\^9 /L; hemoglobin (HGB) ≥ 9.0 g/dL
* Bilirubin ≤ 1.5 times upper limits of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 times ULN
* Serum creatinine ≤ 1.5 times ULN, and creatinine clearance ≥ 60 ml/min (calculated by Cockcroft-Gault formula)
* International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN
* Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline of TSH is outside the normal range, patients with normal total T3 (or FT3) and free tetraiodothyronine (FT4) can also be enrolled
* The myocardial enzyme profile was within the normal range
* For women who are not breastfeeding or pregnant, use contracept…