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. 2024 Sep 3;15:1460282. doi: 10.3389/fimmu.2024.1460282

Table 1.

Ongoing clinical trials of immunotherapy on liver cancer.

NCT Number Study Type Phase Status Sample Size(n) Conditions Outcome Measures
NCT05109052 Interventional I/II Withdrawn 48 HCC Safety and Tolerability
NCT05185505 Interventional IV Recruiting 24 HCC 1 Acute Rejection 2 AE 3 ORR 4 atezolizumab/bevacizumab therapy 5 liver transplantation 6 necrotic tumors 7 RFS 8 OS 9 Tumor biomarkers 10 Immune Cell Biomarkers
NCT05609695 Observational NA Not yet recruiting 100 HCC 1 OS 2 TR 3 PFS
NCT05942560 Interventional NA Not yet recruiting 160 Depression, Anxiety, HCC, CBT 1 Depression symptoms 2 Anxiety symptoms 3 Quality of life score 4 Immune variables 5 OS
NCT05873244 Interventional II Recruiting 44 HCC 1 PFS 2 OS 3 radiological response rate 4 time-to-progression 5 AE
NCT05443230 Observational NA Enrolling by invitation 200 HCC, Sarcopenia 1 Short-term results 2 Long-term results
NCT05717400 Interventional IV Recruiting 15 HCC 1 Overall Response Rate
NCT05484908 Interventional NA Not yet recruiting 60 HCC, Liver Failure, Immune-Mediated Hepatitis 1 Mortality rate 2 Model for end-stage liver disease (MELD) score variation
NCT06045286 Interventional I Recruiting 30 Colorectal Liver Metastases 1 ORR 2 PFS 3 OS
NCT06199232 Interventional NA Not yet recruiting 47 Liver Metastasis Colon Cancer, Failed From Standard Treatment, MSS, ctDNA Genotype 1 PFS 2 OS 3 ORR 4 DCR 5 AE
NCT05550090 Observational NA Recruiting 40 Metastatic Breast Cancer in the Liver 1 Correlation between DCE-MRI parameters combined with IVIM parameters and efficacy of chemotherapy in patients with liver metastasis of breast cancer
NCT05438420 Interventional I/II Recruiting 120 HCC, Cervical Cancer, Esophageal Cancer, Gastric Cancer 1 AE 2 TR 3 Change in the area under curve (AUC) of Q702 and its primary metabolites
NCT06047015 Interventional I/II Not yet recruiting 12 Liver Metastasis Colon Cancer 1 Complications 2 Abscopal effect 3 Tumor-specific immune response 4 PFS 5 Quality of life questionnaire
NCT05677113 Interventional II Recruiting 115 Liver Metastases, Colorectal Cancer 1 PFS 2 Clearance of ctDNA 3 Side-effect profile of QBECO 4 Quality of recovery 5 Five-year overall survival
NCT05833126 Interventional II Recruiting 25 Recurrent Liver Cancer After Liver Transplantation 1 Acute graft rejection rate 2 ORR 3 OS 4 PFS 5 Time to Progression 6 SAE 7 Graft Rejection
NCT05451043 Interventional II Not yet recruiting 62 HCC, Biliary Tract Cancer, Pancreatic Cancer, Cholangiocarcinoma 1 Investigating and establishing the efficacy of propranolol in boosting the effects of immunotherapy 2 Feasibility of study therapy 3 Safety/tolerability 4 PFS 5 OS
NCT05039736 Interventional II Withdrawn 0 HCC 1 overall response rate
NCT05893056 Interventional II Recruiting 25 Gastric Cancer Metastatic to Liver 1 ORR 2 DOR 3 PFS 4 OS 5 DCR 6 Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
NCT05169957 Interventional I Recruiting 18 Liver Metastases, Melanoma, Cutaneous, Melanoma, Mucosal, Melanoma, Ocular, Metastatic Melanoma 1 Percentage of patients who receive all planned radiotherapy 2 Proportion of patients who develop grade 3 or higher toxicity 3 OS 4 PFS 5 Proportion of patients with local control 6 ORR 7 BOR
NCT06117891 Observational NA Recruiting 300 Unresectable Hepatocellular Carcinoma 1 OS 2 Discriptive analysis 3 DOT 4 PFS 5 ORR 6 Treatment sequences post first-line AB or other IO combinations
NCT05588297 Interventional II Not yet recruiting 12 Colorectal Cancer Liver Metastases 1 R0 recession rate 2 Pathological complete response rate 3 TRG 4 ORR 5 EFS 6 DFS 7 OS 7 AE 8 Quality of life score
NCT05322187 Interventional II/III Not yet recruiting 15 HCC, Hepatoblastoma, Pediatric Cancer, Pediatric Solid Tumor, Transitional Cell Tumor 1 ORR 2 dynamic α-fetoprotein response (AFP-R) 3 AE 4 Health outcomes as assessed by the PROMIS® Pediatric Scale v1.0 Global Health 7 + 2 scores at baseline
NCT05510427 Interventional I Withdrawn 0 HCC, Cholangiocarcinoma 1 AE 2 MTD
NCT05984511 Interventional NA Not yet recruiting 234 HCC, Tumor Thrombus, Hepatic Portal Vein Tumor Invasion 1 OS 2 PFS 3 ORR 4 Duration of portal patency 5 AE
NCT05653531 Interventional NA Withdrawn 0 Liver Biomarkers, ICI, Lung Cancer, Transaminases 1 basal ALT blood concentration in lung cancer patients treated with ICI determined
NCT05233358 Interventional NA Not yet recruiting 176 HCC 1 PFS 2 OS 3 To Tumor Untreatable Progression 4 ORR 5 DCR 6 DOR 7 AE
NCT05339581 Interventional NA Not yet recruiting 78 HCC, Liver Transplant; Complications, Portal Vein Thrombosis, Radiotherapy; Complications 1 PVTT RR/NR 2 Alpha Fetoprotein Response (AFP-R) 3 PFS 4 ORR 5 TTP 6 DOR
NCT05411133 Interventional I Recruiting 68 HCC, Cholangiocarcinoma, Colorectal Adenocarcinoma, Esophageal Adenocarcinoma, Gastric Cancer, Gastroesophageal Junction, Gastrointestinal Cancer, Pancreatic Cancer 1 AE 2 Amount of Cabotamig (ARB202) in plasma 3 Biochemical and physiological effects 4 Effect of Cabotamig (ARB202) on tumour
NCT05937295 Interventional I Recruiting 20 Fibrolamellar Hepatocellular Carcinoma 1 To assess immunogenicity in terms of induction of peptide specific T-cell responses 2 Safety and Tolerability
NCT05332496 Observational [Patient Registry] NA Recruiting 220 HCC 1 PFS 2 OS 3 ORR 4 DOR 5 DCR 6 AE
NCT05332821 Observational [Patient Registry] NA Recruiting 474 HCC 1 OS 2 PFS 3 ORR 4 DOR 5 DCR 6 AE
NCT05647954 Interventional III Not yet recruiting 350 Melanoma Neuroendocrine Tumors Neuroectodermal Tumors, Neoplasms Germ Cell and Embryonal Neoplasms by Histologic Type, Neoplasms Neoplasms 1 PFS 2 OS 3 ORR 4 DCR 5 DOR 6 PFS 7 OS 8 AE
NCT05810402 Interventional NA Not yet recruiting 60 HCC, ICI, Liquid Biopsy 1 Percentage of patients with CTCs-PD-L1+ by CellSearch® technique 2 OS 3 PFS
NCT06031480 Interventional II Not yet recruiting 55 HCC 1 ORR
NCT04430452 Interventional II Recruiting 21 HCC 1 ORR 2 AE 3 PFS 4 DOR 5 OS
NCT06040177 Interventional I/II Recruiting 30 HCC Non-resectable, ICI, Portal Vein Tumor Thrombus 1 ORR 2 PFS 3 DCR 4 DOR 5 OS
NCT06205706 Interventional I/II Recruiting 104 HCC, Non Small Cell Lung Cancer, Solid Tumors 1 AE 2 SAE 3 Frequency of dose interruptions and dose reductions 4 DLT
NCT05278195 Observational NA Recruiting 300 HCC 1 OS 2 Specificity 3 Sensitivity 4 The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the radiomics artificial intelligence mode 5 Accuracy
NCT05406466 Interventional II Recruiting 25 Melanoma 1 ORR 2 DCR 3 DOR 4 TTR 5 PFS 6 OS 7 AE
NCT05070247 Interventional I/II Recruiting 313 HCC, Breast Cancer, Esophageal Cancer, Gastric Cancer,
Kidney Cancer, Mesothelioma, Nasopharyngeal Cancer, Non-small Cell Lung Cancer (NSCLC), Non-squamous, Pancreatic Cancer, Squamous Cell Cancer of Head and Neck (SCCHN)
1 Dose Escalation 2 Dose Expansion: Overall Response Rate (ORR) 3 DCR 4 DOR 5 TTR 6 PFS 7 OS 8 AE
NCT05665348 Interventional II/III Not yet recruiting 574 HCC, Metastatic Tumor 1 Objective response of treatment 2 OS 3 PFS 4 OR
NCT05879328 Observational NA Recruiting 12 HCC 1 RFS 2 TR 3 Complication rate 4 OS 5 Patients’ reported outcomes (PROs) 6 Comparison with historical series
NCT04777851 Interventional III Recruiting 496 HCC 1 PFS 2 OS 3 ORR 4 Time to unTACEable Progression (TTUP) 5 DOR
NCT04965714 Interventional II Withdrawn 0 Resectable HCC 1 AE 2 Rate of pathologic complete response 3 Necrosis of tumors 4 TTP 5 RFS 6 OS
NCT06041477 Interventional III Recruiting 540 HCC, Chemotherapeutic Toxicity, Chemotherapy Effect 1 PFS 2 OS 3 ORR 4 DCR 5 CRR 6 Safety profiles of all participants
NCT05897268 Interventional II Recruiting 25 HCC 1 ORR 2 PFS 3 OS 4 DOR 5 DCR 6 ORR 7 PFS 8 OS 9 AE
NCT05096715 Interventional I Not yet recruiting 20 Unresectable HCC 1 Dose Limiting Toxicity Rate 2 PFS 3 OS 4 In-field response rate 5 Change in Child-Pugh Score 6 Out of field response rate
NCT05092373 Interventional I Recruiting 36 too much 1 To assess the safety and tolerability of TTF, including the maximum tolerated dose (MTD) 2 ORR 3 PFS 4 OS
NCT05578430 Interventional II Not yet recruiting 54 Resectable HCC 1 MPR 2 RFS 3 ORR 4 AE
NCT05044676 Observational NA Recruiting 120 HCC 1 OS
NCT05516628 Interventional II Not yet recruiting 30 HCC 1 RFS 2 TTR 3 RFS 4 OS
NCT06218511 Interventional I Recruiting 10 HCC 1 DFS 2 PFS 3 OS 4 AE
NCT05625893 Interventional II Recruiting 63 HCC, Portal Vein Thrombosis 1 PFS 2 AE 3 OS 4 Time-to-progression 5 ORR 6 DCR 7 Local tumor progression rate
NCT04965454 Interventional II Recruiting 80 HCC Non-resectable 1 ORR 2 DCR
NCT05337137 Interventional I/II Recruiting 162 HCC 1 DLT 2 ORR 3 PFS
NCT06133062 Interventional II Recruiting 45 HCC Non-resectable 1 PFS 2 LC 3 TTP 4 ORR 5 OS 6 AE
NCT05537402 Interventional II Recruiting 204 HCC 1 PFS 2 ORR 3 OS
NCT05717738 Observational NA Recruiting 300 HCC Non-resectable 1 Response Rate measured by mRECIST criteria 2 Number of Patients Amendable to Curative Surgical Interventions 3 TTP 4 PFS 5 OS 6 Pathological response 7 DCR 8 Quality of Life (QoL)
NCT05168163 Interventional II Recruiting 122 HCC 1 OS 2 PFS 3 ORR 4 DOR 5 AE
NCT05620771 Interventional II Recruiting 84 HCC 1 PFS 2 TTP 23 ORR 4 DOR 5 CBR 6 OS 7 AE
NCT05389527 Interventional II Active, not recruiting 43 HCC 1 MPR 2 PCR 3 Pathologic complete response (pCR) 4 ORR 5 R0 resection rate 6 DFS 7 OS 8 AE
NCT05488522 Interventional I Recruiting 18 HCC 1 Primary Objective 2 Secondary Objective 3 OS 4 PFS
NCT05101629 Interventional II Active, not recruiting 32 HCC 1 ORR 2 OS 3 Safety and toxicity
NCT05199285 Interventional II Recruiting 40 HCC 1 ORR 2 OS 3 PFS 4 Disease control 5 AE
NCT05822752 Interventional II Recruiting 120 HCC 1 BOR 2 DOR 3 PFS 4 OS
NCT05269381 Interventional I Recruiting 36 too much 1 AE 2 The number and percentage of participants who completed the sequencing with satisfactory data quality registration and identified at least 10 actionable peptides, meet the eligibility criteria for registration, and able to initiate vaccine production 3 Immunogenicity responders
NCT05327738 Interventional II Withdrawn 0 HCC 1 Proportion of progression-free participants 2 ORR 3 DCR 4 TTP 5 PFS 6 OS 7 Incidence of grade >= 3 adverse events
NCT05377034 Interventional II Recruiting 176 Locally Advanced Hepatocellular Carcinoma 1 BOR 2 DOR 3 TOR 4 PFS 5 OS
NCT05286320 Interventional I/II Not yet recruiting 27 Unresectable Hepatocellular Carcinoma, Lenvatinib,
Pembrolizumab, Stereotactic Body Radiotherapy
1 safety rate 2 ORR 3 PFS 4 OS 5 Immune biomarkers
NCT06024252 Observational NA Not yet recruiting 200 HCC 1 OS 2 PFS 3 ORR 4 One-year survival rate 5 Immune-TACE PFS 6 DCR 7 Treatment pattern
NCT05448677 Interventional II Recruiting 196 HCC 1 PFS 2 ORR
NCT05223816 Interventional II Recruiting 97 HCC, Intrahepatic Cholangiocarcinoma 1 Safety in Cohort1 2 ORR 3 PFS
NCT05797805 Interventional I/II Recruiting 108 Advanced Hepatocellular Carcinoma 1 AE 2 DLT 3 Evaluate efficacy of tegavivint as a single agent
NCT05776875 Interventional II Recruiting 24 HCC 1 AE 2 Response rate 3 Time to progression 4 Time to TACE progression (TTTP) 5 Time to untaceable progression
NCT05908786 Interventional I/II Recruiting 150 HCC 1 MPR 2 PCR 3 Relapse-Free Survival (RFS) 4 Event-Free Survival (EFS) 5 OS
NCT05396937 Interventional II Recruiting 42 HCC 1 ORR 2 Duration of Objective Response (DoR) 3 DCR 4 TTP 5 PFS 6 OS
NCT05903456 Interventional II Not yet recruiting 20 HCC 1 ORR 2 PFS 3 OS 4 DCR 5 Disease Control Rate 6 DOR 7 AE
NCT06066333 Interventional II Recruiting 12 ACC, Adrenocortical Carcinoma, Metastatic Adrenocortical Carcinoma 1 AE