Clinical trial · Interventional
PD-L1 PET Imaging During Neoadjuvant (Chemo)Radiotherapy in Esophageal and Rectal Cancer
Programmed Death-ligand 1 Positron Emission Tomography Imaging During Neoadjuvant (Chemo)radiothErapy in Esophageal and Rectal Cancer (PETNEC): a Prospective Non-randomized Open-label Single-center Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The overall aim of this pilot study is to prospectively monitor programmed death-ligand 1 (PD-L1) expression dynamics in vivo, during neoadjuvant chemoradiotherapy (CRT) or short-course preoperative radiotherapy (SCPRT) in rectal and esophageal cancer by a positron emission tomography (PET) imaging approach.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oesophageal Cancer | — | UNRESOLVED | — |
| Rectal Cancer Stage | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CROSS Protocol | Radiation | — | UNRESOLVED |
| CRT | Radiation | — | UNRESOLVED |
| PD-L1 PET | Diagnostic Test | — | UNRESOLVED |
| SCPRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Neoadjuvant Chemoradiotherapy (CRT)
- interventionNames
- Radiation: CRT
- Diagnostic Test: PD-L1 PET
- type
- OTHER
- label
- Short-course preoperative radiotherapy (SCPRT)
- interventionNames
- Radiation: SCPRT
- Diagnostic Test: PD-L1 PET
- type
- OTHER
- label
- Neoadjuvant Chemoradiotherapy (CROSS protocol)
- interventionNames
- Radiation: CROSS Protocol
- Diagnostic Test: PD-L1 PET
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age and older * All sexes * Histologically confirmed carcinoma of the rectum or oesophagus (squamous cell carcinoma and adenocarcinoma, including oesophago-gastric junction cancers) * Medical need for a neoadjuvant CRT/SCPRT * Suitable to withstand the course of neoadjuvant CRT/SCPRT * Written informed consent form (ICF) for participation in the study Exclusion Criteria: * Metastatic disease, which is considered incurable by local therapies (expect for oligometastatic disease with a curative intend) * Previous surgery of the tumor other than biopsy * Pregnancy, breastfeeding or expectancy to conceive * Prior therapy with anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2 or any other agent directed against co-inhibitory T cell receptors or has previously participated in clinical studies with immunotherapy * Disagreement of participants with reproductive potential to use contraception throughout the study period and for up to 180 days after the last dose of study therapy * Hepatitis B or C * Human immunodeficiency virus (HIV) * Immunodeficiency * Allogeneic tissue or solid organ transplantation * Autoimmune disease that has required systemic therapy in the past 2 years with modifying agents, steroids or immunosuppressive drugs * Active non-infectious pneumonitis * Active infection requiring systemic therapy * Systemic steroids or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment * Diagnosed and/or treated additional malignancy within 5 years of randomization, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin and/or curatively-resected in situ cervical and/or breast cancers * Treatment with botanical preparations (i.e. herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks prior to randomization/treatment * Participants with serious or uncontrolled medical disorders * Uncontrolled or significant cardiovascular disease (myocardial infarction, uncontrolled angina, any history of clinically significant arrhythmias, QTc prolongation in males \> 450 ms and \> 470 ms in females, participants with history of myocarditis) * Allergies and adverse drug reaction (history of allergy or hypersensitivity to study drug components, contraindications to any of the study drugs of the chemotherapy regimen) * Other exclusion criteria: Prisoners or participants who are involuntarily incarcerated, participants who are compulsorily detained for treatment of either a psychiatric or physical (i.e. infectious disease) illness
References
Publications (0)
Data not yet available