OncoMatch/Clinical Trials/NCT06406816
Neoantigen Vaccine Plus Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma After Radical Resection
Is NCT06406816 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Chemotherapy
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)
Demographics
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.
Frequently asked questions
Is NCT06406816 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage IB or IIA or IIB or IIIA or IIIB is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages