Ignite Creation Date:
2024-05-06 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03608878
Status:
TERMINATED
Last Update Posted:
2021-05-06
First Post:
2018-07-23
Brief Title:
Adagloxad SimoleninOBI-821 in Combination With TACE Therapy in HCC Patients With GALNT14-rs9679162-non-TT Genotype
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
Randomized Controlled Open Label Clinical Trial for Adagloxad SimoleninOBI-821 in Combination With TACE Therapy in Hepatocellular Carcinoma Patients With GALNT14-rs9679162-non-TT Genotype
Status:
TERMINATED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The biopsies in the first 5 screened patients were all negative for Globo-H of which positive is required to include the patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
TACE against HCC is the standard of care for BCLC stage B patients In this exploratory study the investigators assess the efficacy of TACE with or without adagloxad simoleninOBI-821 treatment in GALNT14 non-TT HCC population
Detailed Description:
Hepatocellular carcinoma HCC is the fifth most common solid cancers worldwide and the third leading cause of cancer-related death Early stage HCC can be cured by surgical removal or non-surgical ablation procedures albeit a high recurrence rate up to 75 in 5 years remains an unsolved problem On the other hand in patients with unresectable HCC the standard therapy is still under intensive clinical investigations In patients without portal vein occlusionthrombosis or extrahepatic metastasis namely Barcelona Clinical Liver Cancer BCLC Stage B transcatheter arterial chemoembolization TACE is believed to be an effective palliative treatment The beneficial effect of TACE on overall survival has been mild to moderate as reviewed in a previous study Thus TACE is generally considered a palliative therapy TACE induces tumor necrosis but at the same time it also induces angiogenesis owing to the increases of hypoxia-inducible factors and endothelial growth factors to trigger regrowth of tumors
It has been known that GALNT14 genotype is associated with treatment responses Patients with GALNT14 TT genotype response well to both TACE and chemotherapy
A new immunotherapy is directed against Globo H a carbohydrate antigen that is expressed at high levels on the surface of a variety of tumor cells These Globo H-specific antibodies can effectively induce complement dependent cytotoxicity CDC as well as antibody-dependent cell-mediated cytotoxicity ADCC by IgM and IgG respectively together with other cellular immune responses to kill tumors In the clinical setting Globo H has been evaluated as the target of active immunotherapy in a few clinical trials including an ongoing Phase IIIII trial of adagloxad simoleninOBI-821 sponsored by OBI Pharma Inc as a potential treatment for stage IV metastatic breast cancers and possibly other cancer types expressing Globo series TACAs Although vaccination with adagloxad simoleninOBI-821 did not improve progression-free survival PFS in patients with previously treated metastatic breast cancer in a post-hoc analysis patients who developed a humoral immune response to Globo H had a longer PFS than those who did not indicating that adagloxad simoleninOBI-821 treatment could be of benefit when an antibody response can be developed
Furthermore overexpression of tumor-specific antigen Globo H can contribute to enhanced tumor angiogenesis and tumor-associated immune suppression and in turn positively correlate with tumor aggressiveness and poor survival in patients In the present study only non-TT less favorable groups will be enrolled and the patients will be randomized to examine the hypothesis that the TACE adagloxad simoleninOBI-821 treatment is beneficial in the BCLC class B advanced HCC patients
It has been known that GALNT14 genotype is associated with treatment responses Patients with GALNT14 TT genotype response well to both TACE and chemotherapy
A new immunotherapy is directed against Globo H a carbohydrate antigen that is expressed at high levels on the surface of a variety of tumor cells These Globo H-specific antibodies can effectively induce complement dependent cytotoxicity CDC as well as antibody-dependent cell-mediated cytotoxicity ADCC by IgM and IgG respectively together with other cellular immune responses to kill tumors In the clinical setting Globo H has been evaluated as the target of active immunotherapy in a few clinical trials including an ongoing Phase IIIII trial of adagloxad simoleninOBI-821 sponsored by OBI Pharma Inc as a potential treatment for stage IV metastatic breast cancers and possibly other cancer types expressing Globo series TACAs Although vaccination with adagloxad simoleninOBI-821 did not improve progression-free survival PFS in patients with previously treated metastatic breast cancer in a post-hoc analysis patients who developed a humoral immune response to Globo H had a longer PFS than those who did not indicating that adagloxad simoleninOBI-821 treatment could be of benefit when an antibody response can be developed
Furthermore overexpression of tumor-specific antigen Globo H can contribute to enhanced tumor angiogenesis and tumor-associated immune suppression and in turn positively correlate with tumor aggressiveness and poor survival in patients In the present study only non-TT less favorable groups will be enrolled and the patients will be randomized to examine the hypothesis that the TACE adagloxad simoleninOBI-821 treatment is beneficial in the BCLC class B advanced HCC patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None