Evaluate the Efficacy and Safety of Activated T-lymphocyte Cell Therapy in Advanced Pancreatic Cancer

Brief summary public domain (ClinicalTrials.gov)

Phase 2 Clinical trial to Evaluate the efficacy and safety of activated T-lymphocyte ("Immuncell-LC") cell therapy in Gemcitabine refractory advanced pancreatic cancer

Detailed description public domain (ClinicalTrials.gov)

This was designed as a single-center, single group clinical trial, and subjects include patients with pathologically-confirmed Gemcitabine refractory advanced pancreatic cancer. If subjects agree to participate in the clinical trial by signing a written consent, only appropriate subjects, who meet the criteria on the examinations and tests, will undergo this clinical trial. To participate in the clinical trial, subject's blood of more than 60 ml should be withdrawn to make a study drug at least 2 weeks before administration. Subjects should visit to hospital according to the protocol and receive a study drug. Therapeutic response rate, overall survival rate, time to progression and the quality of life should be investigated.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Disease Control Rate [Every 2 months from the baseline, up to 16 weeks]. Number, percentage of participants (95% Confidence Interval). Immuncell-LC Group (n=16): 25 (3.78 to 46.22).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Survival (OS) [Every visit, up to 16 weeks]. Median, weeks (95% Confidence Interval). Immuncell-LC Group (n=16): 26.6 (8.6 to 44.6).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Time to Progression [Every 2 months from the baseline, up to 16 weeks]. Median, weeks (95% Confidence Interval). Immuncell-LC Group (n=16): 11 (8.8 to 13.2).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30) [Every one month from the baseline, up to 16 weeks]. Mean, units on a scale (Standard Deviation). Global health status at baseline: Immuncell-LC Group (n=16): 53.65 (0.76 to 5.62). Global health status at last visit: Immuncell-LC Group (n=16): 40.63 (25.98). Physical functioning at baseline: Immuncell-LC Group (n=16): 73.75 (30.64). Physical functioning at last visit: Immuncell-LC Group (n=16): 69.58 (21.63). Role functioning at baseline: Immuncell-LC Group (n=16): 76.04 (32.76). Role functioning at last visit: Immuncell-LC Group (n=16): 59.38 (29.79). Emotional functioning at baseline: Immuncell-LC Group (n=16): 70.31 (20.41). Emotional functioning at last visit: Immuncell-LC Group (n=16): 61.98 (23.56). Cognitive functioning at baseline: Immuncell-LC Group (n=16): 71.88 (24.13). Cognitive functioning at last visit: Immuncell-LC Group (n=16): 68.75 (28.46). Social functioning at baseline: Immuncell-LC Group (n=16): 68.75 (20.97). Social functioning at last visit: Immuncell-LC Group (n=16): 55.21 (27.02). Fatigue at baseline: Immuncell-LC Group (n=16): 40.97 (24.59). Fatigue at last visit: Immuncell-LC Group (n=16): 50.69 (29.25). Nausea/vomiting at baseline: Immuncell-LC Group (n=16): 15.63 (25.44). Nausea/vomiting at last visit: Immuncell-LC Group (n=16): 16.67 (18.26). Pain at baseline: Immuncell-LC Group (n=16): 20.83 (25.46). Pain at last visit: Immuncell-LC Group (n=16): 45.83 (26.87). Dyspnea at baseline: Immuncell-LC Group (n=16): 10.42 (20.07). Dyspnea at last visit: Immuncell-LC Group (n=16): 27.08 (32.70). Constipation at baseline: Immuncell-LC Group (n=16): 16.67 (24.34). Constipation at last visit: Immuncell-LC Group (n=16): 29.17 (40.14). Diarrhea at baseline: Immuncell-LC Group (n=16): 8.33 (25.82). Diarrhea at last visit: Immuncell-LC Group (n=16): 8.33 (19.25). Insomnia at baseline: Immuncell-LC Group (n=16): 14.58 (20.97). Insomnia at last visit: Immuncell-LC Group (n=16): 43.75 (33.82). Appetite loss at baseline: Immuncell-LC Group (n=16): 31.25 (33.26). Appetite loss at last visit: Immuncell-LC Group (n=16): 43.75 (37.94). Financial difficulties at baseline: Immuncell-LC Group (n=16): 27.08 (30.35). Financial difficulties at last visit: Immuncell-LC Group (n=16): 31.25 (33.26). Analysis, Immuncell-LC Group: p=0.123; t-test, 2 sided; superiority or other legacy.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire) [Every one month from the baseline, up to 16 weeks]. Mean, units on a scale (Standard Deviation). Pancreatic pain at baseline: Immuncell-LC Group (n=16): 77.08 (23.07). Pancreatic pain at last visit: Immuncell-LC Group (n=16): 60.42 (25.91). Gastrointestinal at baseline: Immuncell-LC Group (n=16): 78.13 (29.01). Gastrointestinal at last visit: Immuncell-LC Group (n=16): 63.54 (29.32). Jaundice at baseline: Immuncell-LC Group (n=16): 93.75 (11.98). Jaundice at last visit: Immuncell-LC Group (n=16): 87.50 (16.67). Body image at baseline: Immuncell-LC Group (n=16): 56.25 (38.91). Body image at last visit: Immuncell-LC Group (n=16): 56.25 (29.74). Altered bowel habit at baseline: Immuncell-LC Group (n=16): 79.17 (24.72). Altered bowel habit at last visit: Immuncell-LC Group (n=16): 61.46 (24.13). Health satisfaction at baseline: Immuncell-LC Group (n=16): 35.42 (24.25). Health satisfaction at last visit: Immuncell-LC Group (n=16): 34.38 (27.53). Sexuality scale at baseline: Immuncell-LC Group (n=16): 55.21 (39.78). Sexuality scale at last visit: Immuncell-LC Group (n=16): 54.17 (34.16). Bloated abdomen at baseline: Immuncell-LC Group (n=16): 35.42 (25.73). Bloated abdomen at last visit: Immuncell-LC Group (n=16): 54.17 (34.16). Taste changes at baseline: Immuncell-LC Group (n=16): 29.17 (29.50). Taste changes at last visit: Immuncell-LC Group (n=16): 43.75 (35.94). Indigestion at baseline: Immuncell-LC Group (n=16): 27.08 (34.89). Indigestion at last visit: Immuncell-LC Group (n=16): 41.67 (31.03). Flatulence at baseline: Immuncell-LC Group (n=16): 20.83 (23.96). Flatulence at last visit: Immuncell-LC Group (n=16): 33.33 (32.20). Weight loss at baseline: Immuncell-LC Group (n=16): 22.92 (33.82). Weight loss at last visit: Immuncell-LC Group (n=16): 27.08 (25.00). Decreased muscle strength at baseline: Immuncell-LC Group (n=16): 31.25 (30.96). Decreased muscle strength at last visit: Immuncell-LC Group (n=16): 43.75 (29.11). Dry mouth at baseline: Immuncell-LC Group (n=16): 25.00 (31.03). Dry mouth at last visit: Immuncell-LC Group (n=16): 45.83 (34.16). Treatment side effects at baseline: Immuncell-LC Group (n=16): 29.17 (36.26). Treatment side effects at last visit: Immuncell-LC Group (n=16): 39.58 (30.35). Fear for future health at baseline: Immuncell-LC Group (n=16): 52.08 (29.74). Fear for future health at last visit: Immuncell-LC Group (n=16): 58.33 (19.25). Ability to plan ahead at baseline: Immuncell-LC Group (n=16): 31.25 (33.26). Ability to plan ahead at last visit: Immuncell-LC Group (n=16): 52.08 (27.13). Average pain at baseline: Immuncell-LC Group (n=16): 1.13 (1.89). Average pain at last visit: Immuncell-LC Group (n=16): 3.19 (2.43).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Stable Disease(SD) [Every 2 months from the baseline, up to 16 weeks]. Number, number of participants. Immuncell-LC Group (n=16): 4.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Progressive Disease(PD) [Every 2 months from the baseline, up to 16 weeks]. Number, number of participants. Immuncell-LC Group (n=16): 12.