gemcitabine

ALECSAT, in combination with carboplatin and gemcitabine, was safe, well tolerated, and demonstrated promising antitumor activity in mTNBC. These findings support further investigation in larger clinical trials.

This post-transcriptional regulation led to significant LRP1 suppression, subsequently inhibiting proliferation and restoring chemosensitivity. Our findings establish a novel piRNA-guided mechanism for overcoming chemoresistance and suggest that targeting the piR-43452/GTSF1/PIWIL4/LRP1 axis may provide therapeutic benefit in gemcitabine-resistant BCa.

P2, N=38, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial primary completion date: Dec 2025 --> Dec 2026

The TOPAZ-1 study results represented significant advancement in the treatment of advanced biliary tract cancer (BTC) by combining durvalumab with gemcitabine-cisplatin (DGC). Further real-world investigations are still warranted to determine if the DGC regimen has a broader therapeutic indication and to identify predictive markers for survival benefit. Efforts are required to improve the cost-effectiveness of the DGC regimen to facilitate its wider and standardized use.

Our findings directly inform clinical guidelines, address gaps in current therapeutic decision-making. Durvalumab or pembrolizumab combined with GC are optimal first-line regimens for advanced BTC, balancing survival benefits and safety. Sintilimab plus anlotinib combined with GC demonstrates superior PFS but requires further validation. While EGFR inhibitors plus chemotherapy demonstrate potential in KRAS wild-type patients, confirmation in large-scale RCTs is required. PD-L1 expression may represent a promising predictive biomarker for response to PD-1 inhibitor therapy.

The patient remained recurrence-free at 11 months of follow-up after gemcitabine bladder infusion chemotherapy, arterial drug-infusion embolization, systemic chemotherapy, and immunotherapy.

The CHPT1-pSTAT3-SLC7A11 axis governs ferroptosis-dependent chemoresistance in PDAC. Dual targeting of CHPT1 and ferroptosis pathways represents a promising strategy to overcome GEM resistance, highlighting metabolic-kinase crosstalk as a therapeutic vulnerability.

P3, N=320, Not yet recruiting, Genfleet Therapeutics (Shanghai) Inc.

Gemcitabine-cisplatin remains effective and tolerable in metastatic GBC. Despite the emergence of Gemcitabine-Cisplatin with durvalumab as new standard, this prospective dataset provides valuable real-world outcomes from a high-incidence region with limited access to immunotherapy.

P2, N=60, Not yet recruiting, Corcept Therapeutics

Neoadjuvant cisplatin-based combination chemotherapy or perioperative durvalumab with neoadjuvant gemcitabine-cisplatin has been the primary treatment for localized muscle-invasive bladder cancer (MIBC)...Twenty-five patients (cT2-4aN0-2M0) received at least four cycles of RC48 (2.0 mg/kg, Q2W or Q3W) with toripalimab, tislelizumab, or pembrolizumab, followed by radical cystectomy...Treatment-related adverse events were manageable. These findings suggest that RC48 combined with PD-1 inhibitors is a promising neoadjuvant strategy for localized MIBC and warrants further validation in biomarker-selected populations.

P1/2, N=126, Recruiting, Genfleet Therapeutics (Shanghai) Inc.