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
Germany, Spain101 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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
. 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