Phase 1b Study of Response-Guided Neoadjuvant Chemotherapy for Stomach and Gastroesophageal Junction Adenocarcinoma

What this Trial Is About

Researchers are evaluating a response-guided approach to neoadjuvant chemotherapy in patients with Stage IB, II, or III adenocarcinoma of the stomach or gastroesophageal junction. This phase 1b, prospective, single arm, open-label trial aims to determine the effectiveness and feasibility of adjusting chemotherapy based on patient response. The trial focuses on patients eligible for standard neoadjuvant treatment protocols and seeks to improve treatment outcomes by tailoring therapy according to tumor marker changes and imaging results. Participants will receive one of several standard neoadjuvant chemotherapy regimens, including FLOT or FOLFOX, with the possibility of switching treatments based on their response. Response assessments involve CT scans, MRI, and blood tests measuring tumor markers like carcinoembryonic antigen CEA and carbohydrate antigen 19-9 CA19-9. Treatment adjustments may include different chemotherapy combinations such as FOLFIRI, FOLFIRINOX, or immunotherapy agents like nivolumab, pembrolizumab, durvalumab, or trastuzumab, given according to specific schedules. During the study, participants will undergo regular monitoring including imaging scans and blood tests to evaluate tumor response and treatment effects. Researchers will track completion of treatment protocols, rates of surgery gastrectomy completion, negative circulating tumor DNA after neoadjuvant therapy, and adverse events. The study will also assess relapse-free survival over up to three years. Participants are monitored closely for safety and adherence, with study involvement lasting up to three years to capture long-term outcomes.

Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial)