Safety and Efficacy of Immuncell-LC With Gemcitabine in Resectable Pancreatic Cancer
ConditionPancreatic Ductal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19-80
SponsorGC Cell Corporation
About this trial
PURPOSE: This phase III clinical trial evaluates the efficacy and safety of adjuvant Immuncell-LC therapy combined with gemcitabine versus adjuvant gemcitabine single therapy after R0 or R1 resection in patients with pancreatic ductal adenocarcinoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >/=20 years old, </=80 years old.
Participants have undergone a radical full resection (R0) or boundary resection (R1) operation and has elapsed at least two weeks after the resection based on the baseline, up to 12 weeks.
Noncancerous ascites.
No evidence of distant metastasis (such as liver, peritoneum)
Disqualifiers
Received anticancer therapy including chemotherapy, biological therapy, immunotherapy, hormone therapy, radiation therapy, and other anti-cancer treatments. Note: Neo-adjuvant therapy for pancreatic cancer is allowed.
Measurable lesions identified in the pancreas after surgery.
Known history at the screening as defined below.
Confirmed cases of acquired immunodeficiency, which can be exacerbated by immunotherapy.
Trial design
Design model
Parallel
Treatments tested in this trial
Immuncell-LC
DrugIV
Gemcitabine
DrugIV
Treatment groups
408 Participants
are divided into 2 treatment groupsGroup A: Immuncell-LC/GemcitabineExperimental treatment 2 interventions
Group B: GemcitabineActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recurrence free survival (RFS) by independent review
Recurrence free survival is defined as the time from randomization to the date of the recurrence confirmed by independent reviewer
Time frame
Up to approximately 36 months after Last Patient InSecondary outcomes
1
Overall survival (OS)
Overall survival is defined as the time from randomization to death due to any cause.
Time frame
Up to approximately 36 months after Last Patient In2
Recurrence free survival (RFS) by investigator
Recurrence free survival is defined as the time from randomization to the date of the recurrence confirmed by investigator
Time frame
Up to approximately 36 months after Last Patient In3
Carbohydrate antigen 19-9 level
Carbohydrate antigen 19-9 level
Time frame
Up to approximately 36 months after Last Patient In4
Quality of Life (QoL) EORTC QLQ-C30
The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.
Time frame
Up to approximately 36 months after Last Patient InSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov