irinotecan

P3, N=190, Recruiting, Taizhou Hanzhong biomedical co. LTD | Not yet recruiting --> Recruiting | Trial primary completion date: Jan 2026 --> Jun 2026

P2, N=25, Active, not recruiting, Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting --> Active, not recruiting

Here, we use photoactivatable multi-inhibitor liposomes (PMILs) as a clinically translatable strategy to immunomodulate and enhance PDAC treatment using FDA-approved agents: minocycline for tumor priming by downregulating Tdp1, benzoporphyrin derivative incorporated into the liposomal bilayer for photodynamic priming (PDP) of the microenvironment, and irinotecan (IRI) for cytotoxicity. This combination achieved sustained local tumor regression, abscopal effects in untreated distant tumors, and a significant improvement in long-term survival (63%). By integrating clinically approved agents with non-overlapping mechanisms within a light-activated delivery platform, this approach enhances IRI efficacy, reprograms the TME, and promotes antitumor immunity, offering a translatable strategy to sensitize PDAC to chemo- and immunotherapy.

Of note, 6/7 cases with HER-2 mutations exhibited limited benefit from treatment with FOLFIRI plus cetuximab with PFS inferior to 8 months. Taken together, these results highlight the need to test HER-2 gene alterations for patients with RAS/BRAF V600 WT, MSS mCRC, who are candidates for anti-epidermal growth factor receptor therapies.

Systemic therapies, including FOLFIRINOX, gemcitabine plus nab-paclitaxel, and NALIRIFOX, remain the cornerstone of therapies for metastatic disease, with precision medicine offering targeted options such as PARP inhibitors for BRCA-mutated tumors. Modern radiotherapy techniques including stereotactic body radiation therapy and particle therapy enhance local control and reduce toxicity. The integration of next-generation sequencing and multidisciplinary management is essential for improving pancreatic cancer outcomes.

P1/2, N=87, Active, not recruiting, Idience Co., Ltd. | Recruiting --> Active, not recruiting | Trial completion date: Jun 2026 --> Mar 2027 | Trial primary completion date: Sep 2025 --> Jul 2026

P1, N=33, Recruiting, The Methodist Hospital Research Institute | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Jun 2025 --> Jun 2026

Here we provide the basis for further development of trabectedin/irinotecan for patients with ES by the international cooperative groups. ClinicalTrials.gov: NCT04067115 .

P2, N=60, Recruiting, M.D. Anderson Cancer Center | Suspended --> Recruiting

We retrospectively evaluated the clinical outcomes of patients with HER2-positive AGC who received first-line fluoropyrimidine-containing chemotherapy between 2011 and 2023 according to the approval period of each agent in Japan: group A (pre-immunotherapy approval), 2011-2016; group B (nivolumab approval for third-line or later treatment), 2017-2019; and group C (trastuzumab deruxtecan approval for third-line treatment), 2020-2023...The most commonly administered third-line treatments were irinotecan (63%) in group A, immunotherapy (43%) in group B, and trastuzumab deruxtecan (70%) in group C. The proportion of patients receiving trastuzumab deruxtecan at any line gradually increased across the three groups (7.5%, 30.4%, 44.4%; p < 0.0001). The emergence of novel agents and treatment modalities may have contributed to improvements in the survival of patients with HER2-positive AGC. This highlights the benefits of effective treatment strategies, including efforts to identify biomarkers and develop new agents.

In heavily pretreated patients with GI tumors, BI 905711 monotherapy or with FOLFIRI plus bevacizumab displayed a manageable safety profile and limited clinical activity.

Notably, the induction of DOPA-positive cells in the genital skin of albino ICR mice was an unexpected finding, suggesting that drug-induced melanocyte activation may occur independently of intrinsic melanin-producing capacity and instead involve upstream regulatory pathways. Collectively, these findings demonstrate clear strain-dependent and skin site-specific differences in irinotecan-induced melanocyte responses and provide important insights into the heterogeneity of drug-induced skin pigmentation.