Advanced Hepatocellular Carcinoma Clinical Trial
Official title:
Autologous T Cells Modified by Chimeric Antigen Receptor Targeting EpCAM for Clinical Research on Advanced Digestive System Malignancies
A Phase I Clinical Study of Autologous T cells modified with chimeric antigen receptor targeting EpCAM ( EPCAM CAR-T) in Patients with malignant tumors of the digestive system (including advanced gastric cancer, colorectal cancer, liver cancer and pancreatic cancer) .
This is a phase I open-label, single and multiple infusion, dose escalation/cohort expansion study to evaluate the safety, cell pharmacokinetics, and preliminary efficacy of EPCAM CAR-T, infused intravenously in subjects who have been diagnosed with advanced malignant tumors of the digestive system (including advanced gastric cancer, colorectal cancer, liver cancer and pancreatic cancer) and refractory or intolerant to current standard systemic treatment. Primary objectives: •To evaluate the safety and tolerability of EPCAM CAR-T infused intravenously at escalating doses in patients with advanced malignant tumors of the digestive system. Secondary objectives: 1. The treatment of EpCAM CAR-T for patients with advanced digestive system malignancies, according to the dose-limiting toxicity and clinical response, including Possible side effects, determine the maximum tolerated dose (MTD), extended recommended dose (RDE) and/or recommended phase II dose (RP2D). 2. Assess the correlation between the pharmacodynamic (PD) biomarkers of IMC001 and clinical efficacy; EpCAM CAR-T expands and persists in vivo Correlation between sexual and pharmacodynamic (PD) biomarkers and adverse events. 3. To evaluate the preliminary anti-tumor efficacy of EpCAM CAR-T in patients with advanced digestive system malignancies. According to the evaluation criteria for the efficacy of solid tumors (RECIST) Version V.1.1, Evaluation Criteria for Efficacy of Immunotherapy for Solid Tumors (iRECIST), using objective response rate(ORR), duration of remission (DOR), disease control rate (DCR) and progression-free survival (PFS) description preliminary Anti-tumor activity. 4. The incidence of treatment-related adverse events. Exploratory purpose: 1. Assess changes in immune status of EPCAM CAR-T treatment. 2. Assess the change of CTC in the peripheral blood of patients and the clearance effect of CAR-T cell treatment on CTC. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05057845 -
Cryoablation Combined With Tislelizumab Plus Lenvatinib as Second-line or Later Therapy in Advanced Hepatocellular Carcinoma
|
Phase 2 | |
| Recruiting |
NCT02638857 -
Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen Combined With Transcatheter Arterial Chemoembolization for the Treatment of Advanced Hepatocellular Carcinoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT02632006 -
Immunotherapy Using Pluripotent Killer-Programmed Cell Death 1 (PIK-PD-1) Cells for the Treatment of Advanced Hepatocellular Carcinoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT00752063 -
Sorafenib With Capecitabine and Oxaliplatin for Advanced or Metastatic Hepatocellular Carcinoma
|
Phase 2 | |
| Completed |
NCT00517920 -
Phase 2 Study of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)
|
Phase 2 | |
| Recruiting |
NCT05797805 -
A Study of Tegavivint (BC2059) in Patients With Advanced Hepatocellular Carcinoma
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT05070156 -
B010-A Injection for Treating Patients With GPC3 Positive Advanced Hepatocellular Carcinoma
|
Early Phase 1 | |
| Not yet recruiting |
NCT06092112 -
A Clinical Trial for the Safety and Efficacy of CD-801 in Patients With Advanced Hepatocellular Carcinoma
|
Early Phase 1 | |
| Recruiting |
NCT01214343 -
Comparing Efficacy of Sorafenib Versus Sorafenib in Combination With Low-dose FP in Patients With Advanced HCC
|
Phase 3 | |
| Completed |
NCT00999882 -
Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of Tor Kinase Inhibitor in Liver Cancer Patients
|
Phase 1 | |
| Withdrawn |
NCT00756782 -
A Study of TAC-101 in Combination With TACE Versus TACE Alone in Asian Patients With Advanced Hepatocellular Carcinoma
|
Phase 2 | |
| Completed |
NCT00534664 -
Phase I/II Study of Amplitude-Modulated Electromagnetic Fields in the Treatment of Advanced Hepatocellular Carcinoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04503902 -
Toripalimab Combined With Donafenib in the Treatment of Advanced Hepatocellular Carcinoma
|
Phase 1/Phase 2 | |
| Terminated |
NCT04777708 -
BO-112 and Pembrolizumab for the Treatment of PD-1/PD-L1 Refractory Liver Cancer
|
Early Phase 1 | |
| Completed |
NCT04072679 -
Safety and Efficacy Study of Sintilimab Combined With IBI305 in Patients With Advanced Hepatocellular Carcinoma
|
Phase 1 | |
| Suspended |
NCT04066660 -
Study of Oligo-Fucoidan in Advanced Hepatocellular Carcinoma (HCC)
|
N/A | |
| Withdrawn |
NCT05592197 -
Safety and Efficacy of Radiation Plus TACE and Lenvatinib in Advanced HCC With PVTT
|
N/A | |
| Completed |
NCT02528643 -
A Study to Assess the Efficacy and Safety of Enzalutamide in Subjects With Advanced Hepatocellular Carcinoma
|
Phase 2 | |
| Active, not recruiting |
NCT04514484 -
Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV
|
Phase 1 | |
| Recruiting |
NCT04294498 -
Durvalumab for Advanced Hepatocellular Carcinoma in Patients With Active Chronic Hepatitis B Virus Infection
|
Phase 2 |