Cadonilimab Plus FOLFOXIRI and Bevacizumab as First Line Therapy for Metastatic MSS Colorectal Cancer
Interventionsstudie
Phase 2
Fujian Cancer Hospital
Sponsor: Fujian Cancer Hospital
Zuletzt aktualisiert: 15. November 2023 Hinweis - Die Informationen stammen aus öffentlichen Registern und spiegeln möglicherweise nicht die Echtzeitänderungen am lokalen Studienzentrum wider.
Cadonilimab is a first-in-class bispecific, humanized IgG1 antibody targeting PD-1 and CTLA-4, which has the potential to boost immune surveillance in tumors.
This was a phase II study of cadonilimab in combination with bevacizumab and FOLFOXIRI as first line therapy for metastatic microsatellite stable (MSS) colorectal cancer. The goal of this clinical trial is to evaluated the efficacy and safety.
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Behandlungskategorie
Chemotherapie, Checkpoint-Inhibitoren, Andere Medikamente
* Patients with metastatic pMMR or MSS colorectal adenocarcinoma. Note: MMR or MSI status will be performed locally by an immunohistochemistry (IHC) or PCR based test for eligibility.
* Patients who are naïve to systemic treatment in metastatic setting.
* Patients with previous neoadjuvant or adjuvant chemotherapy (that may have included oxaliplatin or investigational VEGF inhibitors) are eligible if the treatment was completed > 12 months before inclusion.
* Patients with the presence of at least one lesion with measurable disease as per RECIST 1.1 guidelines. Lesions in previously irradiated areas should not be considered measurable unless they have clearly progressed since the radiotherapy.
* Patients have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Ausschlusskriterien
* Patients with MSI-H colorectal adenocarcinoma as defined per local assessment using standard of care testing
* Patients with metastatic disease amenable to be resected with potentially curative surgery
* Patients who have received any systemic treatment for metastatic disease.
* Patients with a history of prior treatment with anti-PD-1, anti-PD-L1, anti-PDL2, anti-CTLA-4 antibodies, other checkpoint inhibitors
* Patients who had received radiation within 14 days prior to the first dose of study drug
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Design-Details
ZuteilungN/A
InterventionsmodellSingle Group Assignment
MaskierungNone (Open Label)
Anzahl der Teilnehmer20
Arme & Interventionen
Arme
Interventionen
Typ: Experimental
Beschreibung: Cadonilimab (6mg/kg, iv, Q2W, Day1)+irinotecan* 165 mg/m² iv continue for 1.5 hours, D1; oxaliplatin 85 mg/m² iv continue for 2 hours, D1; leucovorin 400 or levoleucovorin 200 mg/m² iv continue for 2 hours, D1; 5-FU 2400 mg/m² cont. inf. 48h; repeat every 2 weeks (Q2W) + bevacizumab （5mg/kg，d 1）
Interventionen:
Oxaliplatin
irinotecan
5-FU
cadonilimab
leucovorin or levoleucovorin
Ergebnismessungen
Primäre Ergebnismessungen
Overall Response Rate (ORR)Up to two years
RECIST 1.1
Sekundäre Ergebnismessungen
Progression free survival (PFS)Up to two years
RECIST 1.1
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