Status:
NOT_YET_RECRUITING
Timing of Minimally Invasive Local Treatment After First-Line Systemic Therapy in Oligometastatic Esophageal or Gastric Adenocarcinoma
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
UMC Utrecht
Conditions:
Esophageal Cancer
Gastric (Stomach) Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Purpose of the Study: This clinical study investigates whether a shorter or longer duration of systemic therapy before local treatment (surgery or radiation) results in better disease control in pati...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Ability to provide written informed consent
- Histologically confirmed esophageal, gastric or gastroesophageal junction tumor with oligometastatic (M1) disease defined according to the OMEC consensus statement:
- One organ with ≤3 metastases or 1 involved extra-regional lymph node station (based on the TNM 8 classification)
- ≤3 unilobar liver metastases or ≤2 bilobar liver metastases
- ≤ 3 unilateral lung metastases
- Unilateral adrenal gland involvement
- Metastasis confined to 1 bone structure or 1 soft tissue compartment
- Synchronous oligometastatic disease with a resectable primary tumor or metachronous oligometastatic disease (in the event of a locoregional recurrence this should be resectable)
- Metastases should be deemed amenable by the international multidisciplinary expert team for radical local treatment
- WHO performance status 0-2
- Indication for checkpoint inhibition and/or targeted therapy
- PD-L1 with a CPS of 1 or higher as per local clinical practice for immunotherapy use
- HER2 overexpression as per local clinical practice for trastuzumab use
- Claudin 18.2 overexpression as per local clinical practice for zolbetuximab use.
- Any other biomarker that allows targeted therapy in first line approved by EMA
- No prior systemic therapy for metastatic disease
- CT-scan ≤8 weeks prior to inclusion
- Ability to undergo local treatment and start systemic treatment beyond 18 weeks of total systemic treatment.
Exclusion
- Squamous cell carcinoma
- Brain metastases
- Peritoneal or pleural carcinomatosis
- Patients with MSI dMMR
- Uncontrolled immunodeficiency (e.g. AIDS)
- Peripheral neuropathy \>CTCAE grade 1, precluding start of full dose oxaliplatin treatment
- Both organ metastasis and extra-regional lymph node metastasis
- Conditions precluding local treatment or systemic therapy for oligometastatic disease:
- Serious medical comorbidities precluding local treatment (e.g., interstitial lung disease in patients with pulmonary metastasis)
- Clinical or radiological evidence of spinal cord compression or epidural tumor within 2 mm of the spinal cord
- Simultaneous other malignancy or previous other malignancy with a disease-free period of \<5 years, except adequately treated non-melanoma skin cancer or in-situ cancers
- Uncontrolled (bacterial) infections
- Significant concomitant diseases preventing the safe administration of study drugs or likely to interfere with study assessments
- Uncontrolled angina pectoris, cardiac failure or clinically significant arrhythmias
- Continuous use of immunosuppressive agents equivalent to \>10 mg daily prednisone
- Concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine
- Pregnancy or breast feeding
- Patients (M/F) with reproductive potential not implementing adequate contraceptive measures
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2034
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT07000253
Start Date
January 1 2026
End Date
January 1 2034
Last Update
June 2 2025
Active Locations (2)
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1
Amsterdam Univeristy Medical Center
Amsterdam, Netherlands
2
UMC Utrecht
Utrecht, Netherlands