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

NCT07507968 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2026-04-02

No results posted yet for this study

Summary

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.

Conditions

  • Esophagogastric Adenocarcinoma

Interventions

DRUG

Durvalumab

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).

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

    lead OTHER

Principal Investigators

  • Thorsten Götze, Prof. Dr. · Krankenhaus Nordwest, Frankfurt, Deutschland

  • Salah-Eddin Al-Batran, Prof. Dr. · Frankfurter Insitut für Klinische Krebsforschung IKF

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2030-02-01
Completion
2030-02-01

Countries

  • Germany
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07507968 on ClinicalTrials.gov