TNT With FLOT/Durvalumab Plus Post-OP Durvalumab for Resectable Gastroesophageal Adenocarcinoma (NCT07507968) | Clinical Trial Compass
Not Yet RecruitingPhase 2
TNT With FLOT/Durvalumab Plus Post-OP Durvalumab for Resectable Gastroesophageal Adenocarcinoma
Germany101 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. ANC ≥ 1.0x109 cells/L without the use of hematopoietic growth factors
✓. Platelet count ≥ 75 x 109/L (\>75,000 per mm3)\*\*
✓. Hemoglobin ≥ 9 g/dL\*\*
✓. Serum total bilirubin ≤ 1.5x institutional upper normal limit (ULN)
✓. AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional ULN
✓. Patients not receiving therapeutic anticoagulation must have an INR ≤ 1.5 ULN and aPTT ≤ 1.5 ULN. The use of full dose anticoagulants is allowed as long as the INR or PTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose for anticoagulants for at least three weeks at the time of inclusion.
✓. Serum Creatinine ≤ 1.5 x ULN and a calculated creatinine clearance rate \> 40 mL /min.
Exclusion criteria
✕. Malignancy treated with curative intent and cured with no known active disease ≥ 3 years before the first dose of study treatment and of low potential risk for recurrence.
What they're measuring
1
Pathological complete response (pCR)
Timeframe: Approximately 13 months after FPI
Trial details
NCT IDNCT07507968
SponsorInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
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✕. Adequately treated carcinoma in situ without evidence of disease
✕. Undetectable viral RNA
✕. CD4+ count ≥ 350 cells/mm3
✕. No history of acquired immune deficiency syndrome-defining opportunistic infection within the past 12 months, and stable for at least 4 weeks on the same anti-HIV medications (meaning there are no expected further changes in that time to the number or type of antiretroviral drugs in the regimen).
✕. Patients with vitiligo or alopecia
✕. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement