No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
CivaTech Oncology · Industry
Who this trial is looking for
This trial is looking for patients with borderline resectable pancreatic cancer who are scheduled for surgery. Participants will receive a treatment aimed at improving control of cancer during their operation.
Are You a Good Fit for This Trial?
You may be able to join if
I am over 18 years old.
I have signed an informed consent.
I am not pregnant or breastfeeding.
I can undergo anesthesia.
I am scheduled for a Whipple procedure or distal pancreatectomy.
I do not have metastatic disease.
I have been diagnosed with borderline resectable pancreatic adenocarcinoma.
I received neoadjuvant chemoradiation before my surgery.
You may not be able to join if
I am not a surgical candidate.
I have had another invasive cancer in the past 5 years.
I am a candidate for IRE (irreversible electroporation).
I have recurrent or previously resected tumors.
I have a documented history of alcoholism or drug abuse.
I am participating in another clinical trial.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Initial study to evaluate local control and the preferred method of attachment of the CivaSheet in the setting of suspected close or positive margins at the time of surgical tumor removal.
Trial Locations
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Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
* • Subject signed inform consent
* Age \> 18 years
* Not pregnant or breast feeding
* Patient capable of undergoing anesthesia
* Patient selected to undergo Whipple procedure or distal pancreatectomy
* Patient does not have metastatic disease
* Patients will have c…
Inclusion Criteria:
* • Subject signed inform consent
* Age \> 18 years
* Not pregnant or breast feeding
* Patient capable of undergoing anesthesia
* Patient selected to undergo Whipple procedure or distal pancreatectomy
* Patient does not have metastatic disease
* Patients will have close margins
* No prior radiation therapy to the region for separate cancer
* Confirmed diagnosis of borderline resectable or locally advanced pancreatic adenocarcinoma
* Patient Received neoadjuvant chemoradiation (4-10 weeks prior to surgery)
* Chemotherapy was administered for 2-6 cycles with any combination of the following agents:
* Gemcitabine + nb-paclitaxel
* FOLFIRINOX
* Neoadjuvant Chemoradiation was administered as IMRT or 3DCRT (up to 56 Gy), or SBRT (up to 36 Gy) with Pre-operative External beam dose (NCCN)
* up to 56 Gy (1.8-2.0 Gy per fractions) with concurrent gemcitabine, capecitabine, or infusional 5-fluorouracil
Exclusion Criteria:
* Not surgical candidate
* Any other invasive cancer in the past 5 years, except basal cell or squamous cell skin cancer
* An IRE candidate (IRE is Percutaneous irreversible electroporation)
* Recurrent or previously resected tumors
* Documented History of Alcoholism and or drug abuse
* Participant in other clinical trials
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