Organ Preservation With Durvalumab-based Immunotherapy in Combination With Chemoradiation as Definitive Therapy for Early Stage Esophageal Adenocarcinoma With Indication for Radical Surgery

Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study ID
NCT05713838
Phase
PHASE2
Status
Recruiting
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Conditions

  • Esophagus Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    1500 mg Durvalumab, IV, day 1 Q4W (max. 15 cycles)
  • FLOT — DRUG
    50 mg/m² docetaxel, 85 mg/m² oxaliplatin, 200 mg/m² calcium folinate and 2600 mg/m² fluorouracil as 24 h-infusion, 2 cycles
  • mFOLFOX-6 — DRUG
    85 mg/m² oxaliplatin, 200 mg/m² calcium folinate, 400 mg/m² fluorouracil as bolus dose and 1600 mg/m² fluorouracil as 48 h-infusion, ² cycles
  • Radiotherapy — RADIATION
    5 weeks with 5 days a week radiotherapy (25 daily fractions with 2.0 Gy = ∑50Gy)

Study Details

The present clinical trial is a prospective, investigator-initiated, single-arm, open-label, multicenter phase II trial investigating whether a definite organ preservation therapy consisting of the combination of durvalumab with chemoradiation is an efficient and safe treatment option for early stage, cT1 and cT2N0, esophageal adenocarcinoma with indication for radical surgery.

Key Dates

Start date
Aug 28, 2023
Status verified
Sep 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2028

Study Design

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

Arms

  • Experimental: Durvalumab + Chemoradiotherapy
    Core Treatment: * D1: Durvalumab (1500 mg, IV) PLUS FLOT (50 mg/m² docetaxel, 85 mg/m² oxaliplatin, 200 mg/m² calcium folinate and 2600 mg/m² 5-FU 24h) * D15: FLOT (50 mg/m² docetaxel, 85 mg/m² oxaliplatin, 200 mg/m² calcium folinate and 2600 mg/m² 5-FU 24h), * D29: Durvalumab (1500 mg, IV) PLUS mFOLFOX (85 mg/m² oxaliplatin, 200 mg/m² calcium folinate, 400 mg/m² 5-FU bolus and 1600 mg/m² 5-FU 48h) PLUS 50 Gy radiotherapy * 5 weeks with 5 days a week radiotherapy (25 daily fractions, 2.0 Gy = ∑50Gy) * D43: mFOLFOX (85 mg/m² oxaliplatin, 200 mg/m² calcium folinate, 400 mg/m² 5-FU bolus, 1600 mg/m² 5-FU 48h) (radiation cont.) * D57: Durvalumab (1500 mg, IV) PLUS mFOLFOX (85 mg/m² oxaliplatin, 200 mg/m² calcium folinate, 400 mg/m² 5-FU bolus and 1600 mg/m² 5-FU 48h) (radiation cont.) Maintenance Phase Durvalumab monotherapy max. 12 cycles à 4 weeks: Durvalumab (1500 mg, IV, Q4W) D1

Primary Outcome Measure

Rate of clinical and pathological complete response (cCR/pCR) [ Time Frame: 8 weeks after completion of core treatment ]

Central Contacts

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