OncoMatch/Clinical Trials/NCT03942328
Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) Combined With Immune Checkpoint Inhibition After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer
Is NCT03942328 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for stage iii hepatocellular carcinoma ajcc v8.
Treatment: Atezolizumab · Bevacizumab · Pneumococcal 13-valent Conjugate Vaccine · Therapeutic Autologous Dendritic Cells · Durvalumab — This early phase I trial studies the side effects of autologous dendritic cells and a vaccine called Prevnar in combination with immune checkpoint inhibition (with bevacizumab and atezolizumab or druvalumab) in treating patients liver cancer that cannot be removed by surgery (unresectable) after undergoing standard high-dose external beam radiotherapy. Autologous dendritic cells are immune cells generated from patients' own white blood cells that are grown in a special lab and trained to stimulate the immune system to destroy tumor cells. A pneumonia vaccine called Prevnar may also help stimulate the immune system. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Immunotherapy with monoclonal antibodies, such as atezolizumab and durvalumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving autologous dendritic cells and Prevnar in combination with immune checkpoint inhibition after radiotherapy may be safe, and tolerable and may stimulate the body's own immune system to fight against the tumor in patients with unresectable liver cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Cholangiocarcinoma
Disease stage
Required: Stage III, IV (AJCC v8)
Excluded: Stage BARCELONA CLINIC LIVER CANCER (BCLC) STAGE D DISEASE
Stage III Hepatocellular Carcinoma AJCC v8; Stage III Intrahepatic Cholangiocarcinoma AJCC v8; Stage IV Hepatocellular Carcinoma AJCC v8; Stage IV Intrahepatic Cholangiocarcinoma AJCC v8; Unresectable Hepatocellular Carcinoma; Unresectable Intrahepatic Cholangiocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: immune checkpoint inhibitor
Previously received immune modulating therapies including but not limited to immune checkpoint inhibitors targeting PD-1 PDL-1 CTLA4, etc.; or prior dendritic cell therapy
Cannot have received: dendritic cell therapy
Previously received...prior dendritic cell therapy
Cannot have received: liver radiation
Prior liver radiation, including radioembolization
Cannot have received: allogeneic stem cell or solid organ transplantation
Prior allogeneic stem cell or solid organ transplantation
Lab requirements
Blood counts
GROUP 2 HCC ONLY: ANC ≥ 1000/mm^3, ALC ≥ 500/mm^3, AMC ≥ 300/mm^3, platelets ≥ 50,000/mm^3, hemoglobin ≥ 9.0 g/dL. GROUP 3 iCCA ONLY: ANC ≥ 1000/mm^3, ALC ≥ 500/mm^3, AMC ≥ 300/mm^3, platelets ≥ 50,000/mm^3, hemoglobin ≥ 9.0 g/dL.
Kidney function
GROUP 2 HCC ONLY: Creatinine ≤ 2 mg/dL. GROUP 3 iCCA ONLY: Creatinine ≤ 2 mg/dL.
Liver function
GROUP 2 HCC ONLY: Total bilirubin < 1.5 mg/dL; AST and ALT ≤ 5 x ULN. GROUP 3 iCCA ONLY: Total bilirubin < 1.5 x ULN; AST, ALT, ALP ≤ 2.5 x ULN.
GROUP 2 HCC ONLY: ANC ≥ 1000/mm^3; ALC ≥ 500/mm^3; AMC ≥ 300/mm^3; platelets ≥ 50,000/mm^3; hemoglobin ≥ 9.0 g/dL; total bilirubin < 1.5 mg/dL; AST and ALT ≤ 5 x ULN; creatinine ≤ 2 mg/dL; PT/INR/aPTT ≤ 1.5 x ULN; absence of proteinuria. GROUP 3 iCCA ONLY: ANC ≥ 1000/mm^3; ALC ≥ 500/mm^3; AMC ≥ 300/mm^3; platelets ≥ 50,000/mm^3; hemoglobin ≥ 9.0 g/dL; total bilirubin < 1.5 x ULN; AST, ALT, ALP ≤ 2.5 x ULN; creatinine ≤ 2 mg/dL; PT/INR/aPTT ≤ 1.5 x ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Rochester · Rochester, Minnesota
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