Neoadjuvant gemcitabine and cisplatin in combination with perioperative pembrolizumab versus upfront surgery for patients with primary resectable and borderline resectable perihilar and distal cholangiocarcinoma (NEODISCO): A Multicentre Phase 2B/3 Randomised Controlled Trial

Conditions

distal cholangiocarcinoma, Perihilar cholangiocarcinoma

Brief summary

Event free survival

Detailed description

Overall survival, Locoregional failure free interval, Distant metastasis-free interval, Resection rate, Radical resection rate, Postoperative complications (30 and 90 days), Postoperative moratlity (30 and 90 days), (Serious) adverse events, Toxicity (CTCAE V5.0), QoL: EORTC QLQ-C30, QoL: EQ-5D, Clinical response rate (using RECIST), Lymf node status: nodes 8, 9, 12A and 12P will be resected and examined by the pathologist to determine the N status., Serum CA 19-9 and CEA response: defined as the change in CA 19-9 levels after 3 and 6 cycles neoadjuvant, and during follow up after surgery, relative to baseline, Pathologic complete and partial response: assessed using the CAP (College of American Pathologists) pancreas protocol., Expression of biomarkers: including but not limited to analysis of circulation tumor DNA

Related papers

No related papers found yet.

Interventions

DRUGGEMCITABINE

DRUGCISPLATIN

DRUGPEMBROLIZUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Event free survival	—

Secondary

Measure	Time frame
Overall survival, Locoregional failure free interval, Distant metastasis-free interval, Resection rate, Radical resection rate, Postoperative complications (30 and 90 days), Postoperative moratlity (30 and 90 days), (Serious) adverse events, Toxicity (CTCAE V5.0), QoL: EORTC QLQ-C30, QoL: EQ-5D, Clinical response rate (using RECIST), Lymf node status: nodes 8, 9, 12A and 12P will be resected and examined by the pathologist to determine the N status., Serum CA 19-9 and CEA response: defined as the change in CA 19-9 levels after 3 and 6 cycles neoadjuvant, and during follow up after surgery, relative to baseline, Pathologic complete and partial response: assessed using the CAP (College of American Pathologists) pancreas protocol., Expression of biomarkers: including but not limited to analysis of circulation tumor DNA	—

Measure

Time frame

Overall survival, Locoregional failure free interval, Distant metastasis-free interval, Resection rate, Radical resection rate, Postoperative complications (30 and 90 days), Postoperative moratlity (30 and 90 days), (Serious) adverse events, Toxicity (CTCAE V5.0), QoL: EORTC QLQ-C30, QoL: EQ-5D, Clinical response rate (using RECIST), Lymf node status: nodes 8, 9, 12A and 12P will be resected and examined by the pathologist to determine the N status., Serum CA 19-9 and CEA response: defined as the change in CA 19-9 levels after 3 and 6 cycles neoadjuvant, and during follow up after surgery, relative to baseline, Pathologic complete and partial response: assessed using the CAP (College of American Pathologists) pancreas protocol., Expression of biomarkers: including but not limited to analysis of circulation tumor DNA

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Countries

Netherlands

Outcome results

None listed