Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569225
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
GemcitabineCisplatinNab-Paclitaxel and Rilvegostomig in Resectable iCCA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Perioperative Therapy With GemcitabineCisplatinNab-Paclitaxel and Rilvegostomig for Patients With Resectable Intrahepatic Cholangiocarcinoma iCCA - A Phase II Trial
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:
NEOLANGIO
Brief Summary:
Biliary tract cancer is a highly aggressive and heterogeneous group of gastrointestinal cancers that arise from the intra- or extrahepatic bile ducts CCA or the gallbladder GBC1-3 While it accounts for only 07 of all malignant tumors and 3 of all gastrointestinal malignancies in adults both incidence and mortality are increasing Biliary tract cancers usually present at an advanced stage with only approximately 20 of patients being diagnosed with an early-stage disease 1 2 4 There is a high risk of recurrence post curative radical resection with 60-70 of patients recurring within 5 years with 5-year survival of around 25 1 2 5 There is evidence for use of adjuvant chemotherapy with fluoropyrimidine- based regimens as per the BILCAP and ASCOT phase III trials 5-7However despite advances in adjuvant treatment recurrence rates after resection of BTC remain high even with adjuvant chemotherapy For example in the BILCAP study 5-year RFS was reported as 339 95 CI 276 to 402 1 Therefore an unmet need exists to optimize peri-operative treatment to reduce recurrence and improve outcomes in patients with resectable BTC
Detailed Description:
The only curative management for iCCA is radical surgical resection However less than 35 of patients present with resectable disease at diagnosis and postoperative recurrence and relapse rates are around 50-70 Despite advances in diagnostics and therapeutic interventions prognosis remains poor with an overall 5-year survival of less than 201
The results of the TOPAZ-12 and KEYNOTE-9663 study have established PD-L1 durvalumab and PD-1 pembrolizumab inhibition in combination with gemcitabine and cisplatin as a new standard of care highlighting the role of immune checkpoint inhibition in advanced biliary tract cancer BTC In addition the combination of Nab-Paclitaxel and gemcitabine cisplatin has demonstrated efficacy in advanced BTC4 Several clinical trials evaluating the efficacy of neoadjuvant combinational therapy with gemcitabine cisplatin and PD-L1 inhibition are ongoing NCT04989218 NCT06050252 NCT04308174 Neoadjuvant treatment in iCCA allows for delivery of treatment pre surgery and can induce pathological responses and thereby improve survival Rilvegostomig is a novel anti-TIGITanti-PD-1 bispecific antibody that is currently investigated in a Phase III clinical trial ARTEMIDE-01 NCT04995523 for advanced or metastatic PD-L1-positive non-small cell lung cancer The study provided promising preliminary evidence on the safety and efficacy of Rilvegostomig56 Furthermore a Phase III clinical trial ARTEMIDE-Biliary01 using Rilvegostomig in combination with Capecitabine or GemcitabineCisplatin or S-1 as adjuvant therapy for BTC after resection is underway The efficacy of GemcitabineCisplatinNab-Paclitaxel and Rilvegostomig as neoadjuvant treatment in resectable iCCA has yet to be established
This is a phase II open-label multi-centre study to assess efficacy of GemcitabineCisplatinNab-Paclitaxel and Rilvegostomig treatment in pre-surgical setting for upfront resectable iCCA followed by adjuvant GemcitabineCisplatin and Rilvegostomig
40 patients are expected to enrol with resectable iCCA at three sites Patients will receive prior to surgery 2 cycles of combinational therapy with Gemcitabine 800mg Cisplatin 25mg Nab-Paclitaxel 100mg and Rilvegostomig Q3W Post-surgical resection adjuvant therapy will consist of 4 cycles of Gemcitabine 1000mg Cisplatin 25mg and Rilvegostomig Q3W Rilvegostomig Q3W will be continued for a total of 12 months in the adjuvant phase
All participants will be followed for survival until the end of study
Dosing of GemcitabineCisplatinNab-Paclitaxel and Rilvegostomig may be delayed per the trial management groups discretion but dose reduction will not be allowed Toxicity management for GemcitabineCisplatinNab-Paclitaxel and Rilvegostomig-related toxicity including management of immune-mediated reactions infusion-related reactions and non-immune-mediated reactions will be provided in the Toxicity Management Guidelines
The results of the TOPAZ-12 and KEYNOTE-9663 study have established PD-L1 durvalumab and PD-1 pembrolizumab inhibition in combination with gemcitabine and cisplatin as a new standard of care highlighting the role of immune checkpoint inhibition in advanced biliary tract cancer BTC In addition the combination of Nab-Paclitaxel and gemcitabine cisplatin has demonstrated efficacy in advanced BTC4 Several clinical trials evaluating the efficacy of neoadjuvant combinational therapy with gemcitabine cisplatin and PD-L1 inhibition are ongoing NCT04989218 NCT06050252 NCT04308174 Neoadjuvant treatment in iCCA allows for delivery of treatment pre surgery and can induce pathological responses and thereby improve survival Rilvegostomig is a novel anti-TIGITanti-PD-1 bispecific antibody that is currently investigated in a Phase III clinical trial ARTEMIDE-01 NCT04995523 for advanced or metastatic PD-L1-positive non-small cell lung cancer The study provided promising preliminary evidence on the safety and efficacy of Rilvegostomig56 Furthermore a Phase III clinical trial ARTEMIDE-Biliary01 using Rilvegostomig in combination with Capecitabine or GemcitabineCisplatin or S-1 as adjuvant therapy for BTC after resection is underway The efficacy of GemcitabineCisplatinNab-Paclitaxel and Rilvegostomig as neoadjuvant treatment in resectable iCCA has yet to be established
This is a phase II open-label multi-centre study to assess efficacy of GemcitabineCisplatinNab-Paclitaxel and Rilvegostomig treatment in pre-surgical setting for upfront resectable iCCA followed by adjuvant GemcitabineCisplatin and Rilvegostomig
40 patients are expected to enrol with resectable iCCA at three sites Patients will receive prior to surgery 2 cycles of combinational therapy with Gemcitabine 800mg Cisplatin 25mg Nab-Paclitaxel 100mg and Rilvegostomig Q3W Post-surgical resection adjuvant therapy will consist of 4 cycles of Gemcitabine 1000mg Cisplatin 25mg and Rilvegostomig Q3W Rilvegostomig Q3W will be continued for a total of 12 months in the adjuvant phase
All participants will be followed for survival until the end of study
Dosing of GemcitabineCisplatinNab-Paclitaxel and Rilvegostomig may be delayed per the trial management groups discretion but dose reduction will not be allowed Toxicity management for GemcitabineCisplatinNab-Paclitaxel and Rilvegostomig-related toxicity including management of immune-mediated reactions infusion-related reactions and non-immune-mediated reactions will be provided in the Toxicity Management Guidelines
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