leucovorin calcium

P=N/A, N=180, Completed, Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Trial completion date: Sep 2029 --> Dec 2025 | Trial primary completion date: Sep 2027 --> Sep 2025 | Enrolling by invitation --> Completed

NCT05286814 is a phase II non-randomized trial evaluating subcutaneous PDS01ADC in combination with HAIP floxuridine and systemic chemotherapy (FOLFOX or FOLFIRI) in patients with unresectable microsatellite stable or mismatch repair-proficient colorectal liver metastases previously treated with at least one line of systemic chemotherapy...Addition of PDS01ADC is not detrimental to HAIP therapy and is associated with both systemic and intratumoral immune modulation. Initial results warrant continuation to full enrollment for further evaluation of clinical and scientific endpoints.

These findings establish the COP1-LUZP1-MYL9 axis as a therapeutic target for CRLM and oxaliplatin-based chemoresistance. Clinically, COP1 expression profiling in PDOs from postoperative specimens enables a precision strategy for managing oxaliplatin-based chemoresistance, especially in the context of FOLFOX.

Low BLM RNA expression is associated with improved survival after treatment with DNA-damaging agents, whereas low RAD51 expression shows a favorable but nonsignificant trend. These findings are exploratory and suggest that RNA-based HR gene expression may warrant further investigation as a potential prognostic biomarker in metastatic CRC.

P2, N=83, Active, not recruiting, Vejle Hospital | Trial completion date: Dec 2025 --> Dec 2026

Notably, baseline NR3C1 methylation levels predicted response to first-line FOLFIRINOX-based treatment with an acceptable 75% sensitivity and a high specificity of 92.86%. These findings highlight the clinical significance of cfDNA methylation as a minimally invasive biomarker source, emphasizing LAX1, NR3C1, and RCAN3 as prognostic biomarkers in mPDAC. Specifically, baseline NR3C1 methylation emerges as a promising predictor of treatment response, supporting personalized therapeutic strategies in mPDAC.

P2, N=66, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: May 2026 --> Oct 2026 | Trial primary completion date: May 2026 --> Oct 2026

An increase in the frequency of CD8 + T-cells and a decreased frequency of tissue-resident memory 1 (Trm-1) and regulatory T (Treg) cells are associated with a favorable response to neoadjuvant therapy. Spatiotemporal multiomics analysis highlighted tissue-resident macrophages as potential predictive biomarkers and warrants further verification.

Targeted inhibition with the oral BRAF inhibitor encorafenib, combined with intravenous cetuximab targeting epithelial growth factor receptor (EGFR) and standard chemotherapy FOLFOX, has improved outcomes and received FDA approval in 2025 based on results from the phase III BREAKWATER trial...This case demonstrates that rectal and nasogastric administration of encorafenib is feasible, achieves therapeutic plasma concentrations, and induces objective and clinical remission in context of FOLFOX+EC. Short-term safety appeared manageable, though increased infection risk cannot be excluded.

P1, N=681, Recruiting, Astellas Pharma Inc | Trial completion date: Dec 2027 --> Dec 2028 | Trial primary completion date: Dec 2027 --> Dec 2028

Our patient presented with a visceral crisis denoted by impending liver failure, prompting the urgent initiation of first-line systemic therapy with fluorouracil, leucovorin, oxaliplatin and trastuzumab. This resulted in rapid clinical improvement, normalisation of liver function tests and tumour markers, and radiographic response with approximately 50% reduction in hepatic metastatic disease burden. This case underscores the aggressive behaviour and rarity of HER2-positive, AFP-producing gastric cancer, highlighting the critical need for prompt diagnosis and initiation of systemic therapy.