RecruitingNot ApplicableNCT04564482

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


Sponsor

Johannes Laengle, MD, PhD

Enrollment

20 participants

Start Date

Nov 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This imaging study tests a PET scan using a special tracer that targets a protein called PD-L1 — a key part of the immune system's interaction with cancer — to track how tumors in the rectum or esophagus respond to pre-surgery radiation and chemotherapy. **You may be eligible if...** - You are 18 or older with confirmed rectal or esophageal cancer (any sex) - You are scheduled to receive pre-surgery chemoradiation or short-course radiation - You have not had previous surgery on the tumor (biopsy is fine) - You are able to provide written consent **You may NOT be eligible if...** - Your cancer has spread in a way that cannot be treated with curative intent - You are pregnant or breastfeeding - You have previously received immunotherapy drugs (anti-PD-1, anti-PD-L1, anti-CTLA-4) - You have HIV, hepatitis B or C, or an immune deficiency - You have an active autoimmune disease that required systemic treatment in the past 2 years - You had a solid organ transplant or are on immunosuppressant medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONCRT

50 Gy in 2 Gy fractions over 25 working days + capecitabine 1650 mg/m2/d PO

RADIATIONSCPRT

25 Gy in 5 Gy fractions over 5 working days

RADIATIONCROSS Protocol

41.4 Gy in 1.8 Gy fractions over 23 working days + carboplatin AUC of 2 mg/ml/min + paclitaxel 50 mg/m2 IV Q1W

DIAGNOSTIC_TESTPD-L1 PET

10 mg atezolizumab IV followed by 37 MBq 89Zr-atezolizumab IV. PET imaging will be done before neoadjuvant CRT/SCPRT (day 0) and between day 10-14 during CRT/SCPRT.


Locations(1)

Medical University of Vienna

Vienna, Austria

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NCT04564482


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