TNT With FLOT/Durvalumab Plus Post-OP Durvalumab for Resectable Gastroesophageal Adenocarcinoma

Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study ID
NCT07507968
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Esophagogastric Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    In the preoperative treatment phase, patients will receive eight 2-week cycles of FLOT chemotherapy (docetaxel 50 mg/m² IV, oxaliplatin 85 mg/m² IV, folinic acid 200 mg/m² IV, 5-FU 2,600 mg/m² IV; given on day 1 of each 2-weeks cycle \[Q2W\]). In addition, they will receive up to 4 treatments of durvalumab (1,500 mg) administrated by infusion on the first day of every second two-week cycle (Q4W). Four to eight weeks after the last dose of preoperative treatment, patients will undergo surgical resection. Study specifications for surgical resection are consistent with national guidelines. Surgical approaches will be tailored to the individual patient according to local standards with the goal of achieving R0-resection of the primary tumor. Four to twelve weeks after surgery, patients will receive durvalumab (1,500 mg IV, Q4W) monotherapy for a maximum of 10 cycles (14 cycles of durvalumab in total).

Study Details

This trial is designed to evaluate a total neoadjuvant approach using D-FLOT as the new standard backbone in patients with resectable esophagogastric adenocarcinoma. It addresses major limitations of current treatment paradigms, builds directly on the strong clinical signal from the MATTERHORN trial, and offers a rational, biologically sound framework for future therapy intensification and innovation. By moving systemic therapy entirely into the preoperative phase, we aim to: * Improve patient outcomes through better adherence and deeper response * Minimize postoperative therapy-related dropout * Create a platform for rational post-surgical drug testing and individualized treatment escalation The trial will provide pivotal evidence to guide the next generation of curative-intent treatment strategies for EGA.

Key Dates

Start date
Jul 1, 2026
Status verified
Mar 2026
Primary completion
Feb 1, 2030
Completion
Feb 1, 2030

Study Design

Enrollment
101 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab + FLOT
    Up to 8x preoperative cycles FLOT plus up to 4x preoperative cycles durvalumab Followed by surgical resection Followed by postoperative durvalumab (for 10 cycles)

Primary Outcome Measure

Pathological complete response (pCR) [ Time Frame: Approximately 13 months after FPI ]

Central Contacts

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