D-TACE-HAIC Combined With Envafolimab and Lenvatinib for Unresectable ICC (NCT06643208) | Clinical Trial Compass
RecruitingNot Applicable
D-TACE-HAIC Combined With Envafolimab and Lenvatinib for Unresectable ICC
China37 participantsStarted 2024-07-01
Plain-language summary
This is a prospective, single-arm, multicenter, phase II trial to evaluate the efficacy and safety of D-TACE-HAIC (GEMOX protocol) in combination with Envafolimab and Lenvatinib for unresectable intrahepatic cholangiocarcinoma.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Ages of 18 and 75;
* 2\. Child-Pugh liver function grade: A/B;
* 3\. ECOG score (see annex for scoring standards) : ≤1 score;
* 4\. ICC was confirmed by pathology and evaluated by two senior hepatobiliary surgeons as unresectable for surgery (including multiple intrahepatic lesions, local vascular invasion, local lymph node metastasis, and distant metastasis);
* 5\. According to RECIST 1.1 criteria, the patient has at least one measurable lesion (the CT/MRI scan diameter of the lesion can be measured ≥10mm, and the lesion has not received local treatment such as radiotherapy or freezing);
* 6\. The expected survival time is greater than 3 months;
* 7\. Patients who had not received any tumor-related targeting, immunization, radiotherapy or chemotherapy before enrollment;
* 8\. Functional indexes of vital organs met the following requirements: · Routine blood: absolute neutrophil count ≥1.5×109/L, Hb≥9.0g/L, PLT≥75×109/L; · Liver function: total bilirubin ≤1.5 times the upper limit of normal (ULN) (≤2.5 times ULN after biliary drainage in patients with obstructive jaundice); Alanine aminotransferase (ALT), aspartate aminotransferase (AST)≤ 5x ULN, albumin ≥30g /L; · Renal function: serum creatinine ≤1.5mg/dL, creatinine clearance ≥60ml /min; · Coagulation function: International standardized ratio (INR) and activated partial thromboplastin time (APTT)≤1.5 times ULN;
* 9\. No history of severe arrhythmia or heart failure; No history of severe ventilat…
What they're measuring
1
Objective response rate, ORR
Timeframe: Four weeks after the initiation of medication