Neoadjuvant CCRT With Gemcitabine/Durvalumab (MEDI4736) Followed by Adjuvant Gemcitabine/Durvalumab(MEDI4736) in Resectable or Borderline Resectable Pancreatic Cancer

Sponsor
Do-Youn Oh
Study ID
NCT03572400
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine — DRUG
    Neoadjuvant: Weekly Gemcitabine 200 mg/m2 iv Adjuvant: Gemcitabine 1000mg/m2, D1, 8, 15 Q 4 weeks total 6cycles
  • Durvalumab — DRUG
    Neoadjuvant: Durvalumab 1.5g iv Q 4weeks Adjuvant: Durvalumab 1.5g iv Q 4weeks for 1 year

Study Details

\<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).

Key Dates

Start date
Nov 29, 2018
Status verified
Apr 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
71 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Gemcitbine/Durvalumab
    Neoadjuvant CCRT with Gemcitbine/Durvalumab +Adjuvant Gemcitabine/Durvalumab Total 6 cycles, after that, Durvalumab q4wks up to total 1 year

Primary Outcome Measure

Disease-free survival rate [ Time Frame: 8 weeks ]

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