drugset / Trial / NCT04037241
Study of Anti-CEA CAR-T + Chemotherapy VS Chemotherapy Alone in Patients With CEA+Pancreatic Cancer & Liver Metastases
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is a randomized open-label phase 2b study of the efficacy and safety of regional infusion therapy with Anti-CEA CAR-T cells using the hepatic immunotherapy for metastases (HITM) method and the Trisalus pressure enabling drug delivery (PEDD) device alternating with systemic chemotherapy versus chemotherapy alone in patients with CEA-expressing pancreatic adenocarcinoma with liver metastases.
Timeline
- Start
- 2021-11-01
- Primary completion
- 2022-01-01
- Completion
- 2022-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | anti-CEA CAR-T cells | Cell therapy | — | Other |
| Background | Capecitabine | Small molecule | — | — |
| Background | Gemcitabine | Small molecule | — | — |
| Background | Leucovorin | Small molecule | — | — |
| Background | NLIR+FU/FA | Unknown | — | — |
| Background | Paclitaxel | Small molecule | — | — |
| Background | fluorouracil | Small molecule | — | — |