Lonsurf (trifluridine/tipiracil)

P1/2, N=122, Recruiting, Oncolytics Biotech

P2, N=140, Recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Not yet recruiting --> Recruiting | Initiation date: Apr 2025 --> Oct 2025

The ICER of larotrectinib therapy vs regorafenib therapy or larotrectinib therapy vs trifluridine/tipiracil therapy was calculated at 23,321.46 USD/QALY or 22,585.39 USD/QALY. From the perspective of healthcare payers in China, larotrectinib was cost-effective compared to standard of care as a second-line treatment or subsequent treatment for advanced or metastatic CRC patients with NTRK gene fusion-positive.

P3, N=324, Not yet recruiting, Federation Francophone de Cancerologie Digestive

P2, N=236, Not yet recruiting, Sun Yat-sen University

The chemotherapy history included fluoropyrimidine (101 patients, 100%), oxaliplatin (95 patients, 94.1%), irinotecan (82 patients, 81.2%), anti-vascular endothelial growth factor antibody (92 patients, 91.1%) and anti-epidermal growth factor receptor antibody (41 patients, accounting for 87.2% of the RAS wild-type subgroup). The results of the present study suggested that TAS-102 combined with bevacizumab in subsequent treatment may have greater efficacy in rectal cancer than in colon cancer, possibly due to the lower frequency of liver metastases in rectal cancer. However, this finding is exploratory and requires further validation via larger prospective studies.

Here we show that a combination of a thymidine analogue (TAS102) plus PARP inhibitor (PARPi) promotes formation of DNA double-strand breaks (DSBs) and G2-arrest specifically in p53 mutant cancer cells...This sequential triple-drug strategy exhibited robust efficacy in preclinical models of colorectal and pancreatic cancers and was well tolerated in mice. Together, our findings illustrate a promising triple-drug strategy for targeting p53 mutant malignancies.

This study explores a novel sequential immunochemotherapy approach combining a DC-based vaccine with anti-PD-1 immunotherapy and standard chemotherapy in patients with refractory pMMR/MSS mCRC. By integrating cellular immunotherapy without omitting the current standard of care (FTD/TPI plus bevacizumab), the trial aims to enhance treatment efficacy in a setting traditionally resistant to immunological strategies. To the best of our knowledge, this is the only ongoing trial investigating this therapeutic combination in this specific patient population.

P3, N=572, Recruiting, AstraZeneca | Trial completion date: Apr 2027 --> Sep 2026 | Trial primary completion date: Oct 2026 --> May 2026

A mutation in the RAS genes worsens the prognosis, regardless of the line of treatment and the systemic treatment used. The greatest benefit from brachytherapy is seen in patients in the first three lines of treatment without RAS mutations, treated with anti-EGFR chemotherapy in the first line and trifluridine/tipiracil in the third line. Combining brachytherapy of liver metastases with systemic treatment is safe, regardless of the systemic treatment used.

P=N/A, N=818, Completed, Bayer | Active, not recruiting --> Completed