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RecruitingLast updated:17 July 2023

NeoCREATE: This Phase II trial is trying to understand how safe and effective immunotherapy (avelumab) is in combination with chemotherapy (carboplatin and paclitaxel) and radiotherapy in people with operable oesophageal and gastro-oesophageal junction cancerNeoadjuvant Immune-Chemo-Radiotherapy in operable oEsophageal and gastro-oesophageal junction cancers with Carboplatin Paclitaxel Radiotherapy and Avelumab - a Trial assessing feasibility and preliminary Efficacy

Clinical summary

Summary

This is a non-randomised trial with one experimental arm, designed to assess the safety of chemo-radiotherapy-immunotherapy combination in patients with operable oesophageal and gastroeosophageal junction cancer. All participants will receive 5 weeks of weekly carboplatin-paclitaxel-radiotherapy. Avelumab will be given as intravenous infusion at the dose of 10mg/kg over 60 minutes in 250ml sodium chloride 0.9% every 2 weeks concurrently with chemoradiotherapy. A further two doses of 2 weekly avelumab will then be given alone.

Age

People18+

Phase

II

Trial Acronym

NeoCREATE

More information

Trial Identifiers

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Commercial Sponsor

Merck

Scientific Title

Neoadjuvant Immune-Chemo-Radiotherapy in operable oEsophageal and gastro-oesophageal junction cancers with Carboplatin Paclitaxel Radiotherapy and Avelumab - a Trial assessing feasibility and preliminary Efficacy

Eligibility

Inclusion

  • You have certain types of non-cancer medical conditions.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Exclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • Your cancer has not spread to other parts of the body.
Message

Clinical trials have complex eligibility criteria.

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