Ivosidenib Plus mFOLFOXIRI and Celecoxib for BRAF-targeted Therapy-refractory BRAF V600E-mutant Colorectal Cancer Patients
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
BRAF-mutated colorectal cancer, primarily driven by the BRAF V600E mutation, accounts for approximately 5-10% of all colorectal cancer cases and is associated with aggressive disease progression and poor prognosis, particularly in metastatic settings. Following first- and second-line treatments, including chemotherapy and targeted therapy, the median overall survival of patients is typically less than 24 months, and tumor progression is rapid once resistance develops. Previous studies have demonstrated that immune checkpoint inhibitors, such as anti-PD-1 therapies, show limited efficacy in microsatellite-stable (MSS) colorectal cancers but may hold promise when combined with other agents to overcome resistance mechanisms. Ivonescimab, a bispecific antibody targeting PD-1 and VEGF, has shown antitumor activity in various solid tumors by simultaneously inhibiting immune evasion and angiogenesis. The combination of ivonescimab with intensive chemotherapy like FOLFOXIRI (folinic acid, 5-fluorouracil, oxaliplatin, and irinotecan) and the COX-2 inhibitor celecoxib aims to enhance antitumor immunity, reduce inflammation, and improve vascular normalization in resistant tumors. However, there are no reported studies on this specific combination for chemotherapy- and BRAF inhibitor-resistant BRAF-mutated colorectal cancer. Therefore, the aim of this study is to evaluate the efficacy and safety of ivonescimab combined with FOLFOXIRI and celecoxib in patients with chemotherapy- and BRAF inhibitor-resistant BRAF-mutated advanced colorectal cancer, with a focus on assessing objective response rate (ORR) and tolerability.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek od 18 do 70 lat
- •Diagnoza raka jelita grubego (okrężnicy lub odbytnicy) z przerzutami do odległych narządów
- •Potwierdzona mutacja genetyczna BRAF V600E
- •Poprzednie leczenie chemioterapią (FOLFOX/CAPOX lub FOLFIRI/CAPIRI) bez powodzenia
- •Poprzednie leczenie lekami ukierunkowanymi na BRAF (np. wemurafenib, dabrafenib) bez powodzenia
- •Mierzalne zmiany nowotworowe
- •Wystarczająca funkcja wątroby, nerek i szpiku kostnego
- •Gotowość do stosowania antykoncepcji (mężczyźni i kobiety w wieku rozrodczym)
✗ Disqualifies
- •Dodatkowe mutacje genetyczne (KRAS, NRAS) lub wzmocnienie genu ERBB2
- •Niedrożność jelit, krwawienie z przewodu pokarmowego lub perforacja jelita wymagająca pilnej interwencji
- •Poprzednia terapia immunologiczna lub leki biologiczne w ciągu 4 tygodni przed badaniem
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Last updated (source)
- September 9, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Gastrointestinal Hospital, Sun Yat-sen University
Guangzhou, China
Trial contact
Yanhong Deng, M.D.
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/10/2026.
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