OncoMatch/Clinical Trials/NCT06406816
Neoantigen Vaccine Plus Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma After Radical Resection
Is NCT06406816 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies Neoantigen Vaccine plus Capecitabine for intrahepatic cholangiocarcinoma.
Treatment: Neoantigen Vaccine plus Capecitabine — This study is a single-arm, open-label, exploratory clinical trial, with the primary objective to evaluate the efficacy and safety of the Neoantigen Vaccine plus capecitabine for the treatment of high-intermediate risk recurrent intrahepatic cholangiocarcinoma
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Disease stage
Required: Stage IB, IIA, IIB, IIIA, IIIB (AJCC TNM (8th edition, 2017))
classified as stage IB-IIIB according to AJCC TNM (8th edition, 2017)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: surgical resection — adjuvant
underwent surgical resection
Cannot have received: neoadjuvant therapy
Not receiving neoadjuvant therapy
Cannot have received: systemic adjuvant therapy
have not yet received systemic adjuvant therapy
Lab requirements
Blood counts
ANC ≥1.5×10^9/L; Platelet count ≥50×10^9/L; Hemoglobin ≥90g/L
Kidney function
Serum creatinine ≤1.5×ULN, or if >1.5×ULN, creatinine clearance rate (CCr) ≥45 mL/min; Urine protein <2+; if ≥2+, 24-hour urine protein quantification <1 g
Liver function
Total bilirubin (TBIL) ≤3×ULN; ALT and AST ≤5×ULN; Serum albumin ≥30g/L; Child-Pugh score grade A
Child-Pugh score grade A; ... Laboratory test values meet the following requirements, as follows: a. Hematology: Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelet count (PLT) ≥50×10^9/L; Hemoglobin (HGB) ≥90g/L b. Liver function: Total bilirubin (TBIL) ≤3×ULN; Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤5×ULN; Serum albumin ≥30g/L c. Renal function: Serum creatinine (Cr) ≤1.5×ULN, or for subjects with creatinine >1.5×ULN, creatinine clearance rate (CCr) ≥45 mL/min (Cockcroft-Gault formula); Urine routine results show urine protein <2+; For subjects with urine protein ≥2+ on baseline urine routine testing, 24-hour urine collection should be performed and 24-hour urine protein quantification <1 g d. Coagulation function: International normalized ratio (INR) or APTT ≤1.5×ULN;
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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