Clinical trialPhase 2Unknown
Neoadjuvant CCRT With Gemcitabine/Durvalumab (MEDI4736) Followed by Adjuvant Gemcitabine/Durvalumab(MEDI4736) in Resectable or Borderline Resectable Pancreatic Cancer
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Unknown
- Study type
- Interventional
- Start
- 29 November 2018
- Expected end
- 31 December 2024
- Enrollment
- 71 participants
- Sites
- 1
- Primary outcomes
- Disease-free survival rate
- Sponsor
- Other
- Results posted
- No
- Last update
- 19 April 2024
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Brief summary public domain (ClinicalTrials.gov)
\<Research Hypothesis\> The dynamics of immune cells by CCRT/Durvalumab will be uncovered. The combination of Durvalumab with concurrent chemoradiotherapy (CCRT/gemcitabine)) as neoaduvant treatment in resectable or borderline resectable pancreatic cancer is feasible and efficacious. The combination of Durvalumab with cytotoxic chemotherapy (gemcitabine) as an adjuvant treatment is feasible and efficacious. \<Objectives\> To assess the effect of Neoadjuvant CCRT with Gemcitabine/Durvalumab followed by adjuvant Gemcitabine/Durvalumab in resectable or borderline resectable pancreatic cancer Primary endpoint: 2 year-DFSR (disease-free survival rate) Secondary endpoints * Efficacy: 2 year-OSR (overall survival rate), disease-free survival, overall survival, overall response rate (RECIST 1.1, ir response) after neoadjuvant CCRT, disease control rateEORTC QLQ-C30, the number of immune cells (TIL, macrophage, etc) in resected pancreatic tissue * Safety: toxicity (CTCAE V), irAE, Exploratory Objective(s): * To evaluate baseline measures and changes of immune systems and regulations by neoadjuvant CCRT with gemcitabine/Durvalumab in peripheral blood and tumor tissues * To collect and store DNA from blood (according to ethical procedures) for future exploratory research into genes/genetic variation that may influence response (ie, distribution, safety, tolerability and efficacy) to study treatments and or susceptibility to disease (optional).