Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546969
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Chemoimmunotherapy Combined With Hyperthermia and Spatially-Fractionated Radiotherapy in Advanced Biliary Tract Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pilot Study of Chemoimmunotherapy Combined With Hyperthermia and Spatially-Fractionated Radiotherapy in Advanced Biliary Tract Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being done to see if the investigators can improve the outcome of patients with biliary tract cancer that do not qualify for surgery This study will compare the effects good andor bad of using a combination of standard of care chemoimmunotherapy with the addition of radiation and deep hyperthermia In this study participants will be receiving standard of care chemoimmunotherapy gemcitabine cisplatin and durvalumab radiation spatially fractionated radiation therapy and deep hyperthermia
Chemoimmunotherapy Chemoimmunotherapy is when chemotherapy drugs are combined with immunotherapy drugs Chemotherapy uses different drugs to kill or slow the growth of cancer cells whereas immunotherapy drugs are used to help the immune system attack cancer cells For this study the drugs Gemcitabine Cisplatin and Durvalumab will be used Chemoimmunotherapy will be delivered over 4 cycles for this study and can continue longer if the treating physician decides this is appropriate Each cycle will last 3 weeks
Spatially fractionated radiation therapy SFRT SFRT is a form of radiation therapy that gives a single large dose of radiation to large tumors or tumors that do not qualify for surgery This is not a standard type of treatment for people with this diagnosis For this study participants will be receiving radiation once on day 1 of the second chemoimmunotherapy cycle
Deep Hyperthermia HT Hyperthermia is used in combination with chemoimmunotherapy and radiation treatment in this study Hyperthermia has the potential to make both chemotherapy and radiation treatments more effective For this study participants will receive HT three times on the first day of cycles 2 3 and 4 of chemoimmunotherapy
Chemoimmunotherapy Chemoimmunotherapy is when chemotherapy drugs are combined with immunotherapy drugs Chemotherapy uses different drugs to kill or slow the growth of cancer cells whereas immunotherapy drugs are used to help the immune system attack cancer cells For this study the drugs Gemcitabine Cisplatin and Durvalumab will be used Chemoimmunotherapy will be delivered over 4 cycles for this study and can continue longer if the treating physician decides this is appropriate Each cycle will last 3 weeks
Spatially fractionated radiation therapy SFRT SFRT is a form of radiation therapy that gives a single large dose of radiation to large tumors or tumors that do not qualify for surgery This is not a standard type of treatment for people with this diagnosis For this study participants will be receiving radiation once on day 1 of the second chemoimmunotherapy cycle
Deep Hyperthermia HT Hyperthermia is used in combination with chemoimmunotherapy and radiation treatment in this study Hyperthermia has the potential to make both chemotherapy and radiation treatments more effective For this study participants will receive HT three times on the first day of cycles 2 3 and 4 of chemoimmunotherapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None