Gastroesophageal Junction Adenocarcinoma

P2, N=48, Recruiting, The First Affiliated Hospital with Nanjing Medical University

Patients were randomized 1:1 to receive zolbetuximab plus chemotherapy or placebo plus chemotherapy (mFOLFOX6 [modified folinic acid, 5-fluorouracil, and oxaliplatin] or CAPOX [capecitabine and oxaliplatin]). Zolbetuximab plus chemotherapy demonstrated favorable PFS and OS versus placebo plus chemotherapy in the Korean subgroup, with numerically greater efficacy compared with the overall pooled population. This may be potentially attributable to low rates of zolbetuximab discontinuation and toxicity management.

P3, N=738, Completed, Merck Sharp & Dohme LLC | Active, not recruiting --> Completed

Finally, we identify current limitations in the field, including inconsistent CLDN18.2 testing criteria, and outline prioritized future directions to optimize integration of CLDN18.2-directed therapies across gastrointestinal cancers. By looking beyond zolbetuximab and incorporating cross-platform comparison, immuno-oncology considerations, and multi-tumor context, this review provides a broad and forward-looking framework to guide clinical application and next-generation research in CLDN18.2-targeted therapy.

P2, N=30, Not yet recruiting, Xijing Hospital

The GEMSTONE-303 trial demonstrated that sugemalimab combined with capecitabine and oxaliplatin (CAPOX) improved survival benefit in patients with advanced gastric/gastroesophageal junction cancer (GC/GEJC) and a programmed death-ligand 1 (PD-L1) combined positive score (CPS) ≥5. It is essential to adopt a combination of targeted patient selection, price negotiation, and broader PAP access to bring the ICER below the WTP threshold. These findings inform reimbursement negotiations and highlight the need for stratified pricing strategies to optimize accessibility in economically diverse populations.

P3, N=204, Completed, Shanghai Cancer Hospital, China | Recruiting --> Completed | N=682 --> 204

This outcome highlights the potential benefits of comprehensive approaches and the feasibility of proactive local interventions for oligoprogressive disease. This case provides valuable experience for managing similar cases and offers new ideas for combining novel modalities like antibody-drug conjugates (ADC) drugs, immunotherapy, and radiotherapy.

P2, N=30, Not yet recruiting, Shanghai Zhongshan Hospital

P=N/A, N=28, Completed, Xijing Hospital | Recruiting --> Completed | Trial completion date: Jul 2026 --> Oct 2025

P=N/A, N=6000, Not yet recruiting, Imperial College London

P=N/A, N=67, Not yet recruiting, Shanghai Zhongshan Hospital