P2, N=31, Recruiting, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

This phase II study (ChiCTR2300077718) aimed to assess the efficacy and safety of balloon-occluded HAIC (bHAIC) based on the FOLFOX (oxaliplatin plus fluorouracil and leucovorin) regimen (bHAIC-FO) in unresectable HCC. bHAIC-FO demonstrates encouraging efficacy and acceptable safety profiles in unresectable HCC treatment, particularly in treatment-naive patients. www.chictr.org.cn, identifier ChiCTR2300077718.

This pooled analysis of candidates considered optimal for initial anti-EGFR-based therapy supports both stop and go and maintenance as de-intensification strategies to consider in shared decision making. Adequately powered phase III studies are advocated to compare the two strategies.

Patients underwent 135 sessions using either HepaSphere beads plus HAIC-FOLFOX (HEPA-HAIC, n = 33) or DC bead plus HAIC-FOLFOX (DCB-HAIC, n = 29)...Nausea, vomiting, and severe pain were significantly less frequent with HEPA-HAIC (5.6% vs 31.7%, p = 0.001; 4.2% vs 31.7%, p < 0.001; 8.3% vs 22.2%, p = 0.01). DEB-TACE plus HAIC was feasible and demonstrated intrahepatic disease control with acceptable tolerability in unresectable GCLM; HEPA-HAIC showed a favorable safety profile.

P2, N=184, Recruiting, KK Women's and Children's Hospital

This case underscores the role of immunotherapy in POLE-mutated tumors regardless of the site of origin and highlights the potential usefulness of molecular profiling in rare malignancies. In line with the agnostic approach used for microsatellite instability, molecular-driven clinical trials should be prioritized over histology-based studies to optimize treatment strategies for these orphan diseases.

Neoadjuvant treatment with T-DXd plus 5-FU/FA was found to be well tolerated and showed preliminary signs of activity during the safety run-in period of the NeoART study.

P2, N=236, Recruiting, Sixth Affiliated Hospital, Sun Yat-sen University | Not yet recruiting --> Recruiting

P3, N=738, Active, not recruiting, Sun Yat-sen University | Trial completion date: Apr 2026 --> Apr 2031

This study evaluated intratumoral PKM2 expression as a predictive biomarker for the effectiveness of oxaliplatin-based adjuvant chemotherapy in stage II/III colorectal cancer...Ninety-three (48%) and 52 (27%) patients received 5-fluorouracil (5-FU) and FOLFOX, respectively...Intratumoral PKM2 expression may be a regimen-specific predictive biomarker for survival benefit from adjuvant FOLFOX in stage II/III colorectal cancer. Prospective validation is warranted before clinical implementation.

Importantly, DKC1-mediated sphingolipid dysregulation promotes first-line chemoresistance, and FOLFOX-resistant patient-derived organoids effectively respond to DKC1 and WNT signaling inhibitors. Conclusively, we identify the DKC1/WNT axis as a therapeutic target in therapy-resistant CRC and underscore complex sphingolipids as promising plasma-based biomarkers.

P1, N=25, Completed, Massachusetts General Hospital | Trial completion date: Feb 2024 --> Apr 2026