Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05749900
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-01
First Post:
2023-02-19
Brief Title:
First-line Trastuzumab Gemcitabine Cisplatin and Nivolumab in Advanced HER2- Positive Biliary Tract Cancer a Multicenter Open-label Single-arm Phase IbII Trial HERBOT
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
First-line Trastuzumab Plus Chemoimmunotherapy for Biliary Tract Cancer HERBOT Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Biliary tract cancer is a rare malignant neoplasm including intrahepatic cholangiocarcinoma IhCCA extrahepatic cholangiocarcinoma EhCCA and Gallbladder cancer GBC Survival outcome of advanced BTCs are still poor and heterogeneity of tissue and molecular differences between BTCs limit the clinical studies in BTCs
Combination therapy of Gemcitabine and Cisplatin has become the standard of care after the ABC-02 trial This trial demonstrated that the addition of cisplatin to gemcitabine improved survival outcomes compared to that with gemcitabine alone However the median overall survival OS of GemCis chemotherapy is only about one year
Anti-Program cell death-1 anti-PD-1 inhibitor monotherapy including Nivolumab OPDIVO had shown efficacy in refractory advanced BTC Various ICIs combined with GemCis as the 1st line treatment in BTCs are under the trials Combination of Nivolumab and GemCis showed improved overall survival 154 months in a small sized study n30 with tolerable side effects in advanced BTC patients Recently reported interim analysis of phase III TOPAZ-1 trial NCT03875235 showed Durvalumab anti-PD-L1 agent combined with GemCis showed improvement of overall survival Considering other studies currently ongoing ICIs combined with GemCis are thought to be the future standard of care in 1st line treatment of advanced stage BTCs
HER2 amplificationoverexpression is presented as many as 15 of total BTC patients Basket trial of administration of pertuzumab and trastuzumab combination in previously treated HER2 positive advanced BTC patients showed promising overall response rate of 23 Also multicenter phase II study conducted by Korean investigators KCSG-HB19-14 showed promising effect of Trastuzumab combined with modified FOLFOX in GemCis refractory HER2 positive BTC patients with ORR of 294 Moreover preclinical data showed synergistic anti-cancer effect of trastuzumab combined with ICIs in HER2 positive cancers Similar data are reported in HER2 positive gastric cancer that phase II and phase III clinical data showed 1st-line ICIs combined with trastuzumab and cytotoxic chemotherapy showed promising overall survival outcomes
In treating HER2-positive advanced BTC the triple combination of nivolumab trastuzumab and cytotoxic chemotherapy GemCis may overcome innate resistance and activate an immune response to cancer along with inhibiting oncogenic signal from HER2 pathway resulting in a synergistic effect with a longer response
Combination therapy of Gemcitabine and Cisplatin has become the standard of care after the ABC-02 trial This trial demonstrated that the addition of cisplatin to gemcitabine improved survival outcomes compared to that with gemcitabine alone However the median overall survival OS of GemCis chemotherapy is only about one year
Anti-Program cell death-1 anti-PD-1 inhibitor monotherapy including Nivolumab OPDIVO had shown efficacy in refractory advanced BTC Various ICIs combined with GemCis as the 1st line treatment in BTCs are under the trials Combination of Nivolumab and GemCis showed improved overall survival 154 months in a small sized study n30 with tolerable side effects in advanced BTC patients Recently reported interim analysis of phase III TOPAZ-1 trial NCT03875235 showed Durvalumab anti-PD-L1 agent combined with GemCis showed improvement of overall survival Considering other studies currently ongoing ICIs combined with GemCis are thought to be the future standard of care in 1st line treatment of advanced stage BTCs
HER2 amplificationoverexpression is presented as many as 15 of total BTC patients Basket trial of administration of pertuzumab and trastuzumab combination in previously treated HER2 positive advanced BTC patients showed promising overall response rate of 23 Also multicenter phase II study conducted by Korean investigators KCSG-HB19-14 showed promising effect of Trastuzumab combined with modified FOLFOX in GemCis refractory HER2 positive BTC patients with ORR of 294 Moreover preclinical data showed synergistic anti-cancer effect of trastuzumab combined with ICIs in HER2 positive cancers Similar data are reported in HER2 positive gastric cancer that phase II and phase III clinical data showed 1st-line ICIs combined with trastuzumab and cytotoxic chemotherapy showed promising overall survival outcomes
In treating HER2-positive advanced BTC the triple combination of nivolumab trastuzumab and cytotoxic chemotherapy GemCis may overcome innate resistance and activate an immune response to cancer along with inhibiting oncogenic signal from HER2 pathway resulting in a synergistic effect with a longer response
Detailed Description:
This phase IbII study is designed to see whether trastuzumabnivolumabgemcitabinecisplatin is active as palliative 1st line treatment for HER2-positive biliary tract cancer 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