Combined S-1 With DC+CIK As Maintenance Therapy For Advanced Pancreatic Ductal Adenocarcinoma
NCT ID: NCT05955157
Last Updated: 2024-01-10
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE2/PHASE3
Total Enrollment
52 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-01-03
Study Completion Date
2025-06-30
Brief Summary
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The goal of this randomized phase 2 controlled clinical trial is to study safety, efficacy of S-1 combined DC+CIK maintenance therapy compared with S-1 alone in improving clinical benefit rate (CBR) among advanced PDAC patients. The main objectives aim to be achieved through this study are :
1. To evaluate the safety of DC+CIK combined immunotherapy when administered with the chemotherapy S-1 as maintenance therapy following first-line chemotherapy regime to advanced pancreatic ductal adenocarcinoma patients.
2. To demonstrate the superiority of of DC+CIK combined immunotherapy in improving clinical benefit rate (CBR) of advanced pancreatic ductal adenocarcinoma patients when administered with the chemotherapy S-1 as maintenance therapy following first-line chemotherapy regime.
3. To investigate the ability of S-1 combined DC+CIK maintenance therapy in reducing pancreatic ductal adenocarcinoma patients' circulating cancer stem cells (CSCs).
In this study, subjects who achieve at least stable disease or partial response will be randomized in ratio of 1:1 into treatment group: DC-CIK plus S1 (27 patients) and control group: S-1 alone (27 patients). For treatment group, they will be infused with DC first, followed by CIK immune cells on day 1. DC+CIK immunotherapy will be repeated for another 2 times (day 8 and 15) as one cycle. All patients are left to rest for a week (start from day 21) prior to receive another 3 times of infusion (day 28, 35 and 42) if condition allowed. Additional third cycle can be performed on those who tolerate well with no toxicity or respond very well. Patients from treatment group will be assessed for their eligibility to receive booster dose on following conditions: 1) tumour achieves partial response or stable disease and 2) ECOG-PS performance status of 0-2 and 3) doesn't exhibit grade 1 and 2 toxicities to improve tumour control.
Additionally, S-1 will be given twice daily after meals for 2 weeks as first cycle along with DC+CIK. Next second cycle of S-1 will be given after 7-days (1 week) rest. The cycles will be repeated every 21 days until disease progression, unacceptable toxic effects, or withdrawal with consent. Dose of S-1 will be determined according to the body surface area.
Meanwhile, patients from control group will receive S-1 alone as maintenance therapy twice daily after meals for 14 days (2 weeks) as one cycle. The next cycle of S-1 will be given after 7-days rest. The cycles will be repeated every 21 days until disease progression, unacceptable toxic effects, or withdrawal with consent.
1. To evaluate the safety of DC+CIK combined immunotherapy when administered with the chemotherapy S-1 as maintenance therapy following first-line chemotherapy regime to advanced pancreatic ductal adenocarcinoma patients.
2. To demonstrate the superiority of of DC+CIK combined immunotherapy in improving clinical benefit rate (CBR) of advanced pancreatic ductal adenocarcinoma patients when administered with the chemotherapy S-1 as maintenance therapy following first-line chemotherapy regime.
3. To investigate the ability of S-1 combined DC+CIK maintenance therapy in reducing pancreatic ductal adenocarcinoma patients' circulating cancer stem cells (CSCs).
In this study, subjects who achieve at least stable disease or partial response will be randomized in ratio of 1:1 into treatment group: DC-CIK plus S1 (27 patients) and control group: S-1 alone (27 patients). For treatment group, they will be infused with DC first, followed by CIK immune cells on day 1. DC+CIK immunotherapy will be repeated for another 2 times (day 8 and 15) as one cycle. All patients are left to rest for a week (start from day 21) prior to receive another 3 times of infusion (day 28, 35 and 42) if condition allowed. Additional third cycle can be performed on those who tolerate well with no toxicity or respond very well. Patients from treatment group will be assessed for their eligibility to receive booster dose on following conditions: 1) tumour achieves partial response or stable disease and 2) ECOG-PS performance status of 0-2 and 3) doesn't exhibit grade 1 and 2 toxicities to improve tumour control.
Additionally, S-1 will be given twice daily after meals for 2 weeks as first cycle along with DC+CIK. Next second cycle of S-1 will be given after 7-days (1 week) rest. The cycles will be repeated every 21 days until disease progression, unacceptable toxic effects, or withdrawal with consent. Dose of S-1 will be determined according to the body surface area.
Meanwhile, patients from control group will receive S-1 alone as maintenance therapy twice daily after meals for 14 days (2 weeks) as one cycle. The next cycle of S-1 will be given after 7-days rest. The cycles will be repeated every 21 days until disease progression, unacceptable toxic effects, or withdrawal with consent.
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Detailed Description
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This trial is designed as randomized phase 2 controlled clinical trial.
Subjects who fulfill following inclusion criteria will be admitted to this phase 2 trial and will be excluded if they fulfill any one of the exclusion criteria. All patients must have undergone first-line of chemotherapy (either modified FOLFIRINOX or gemcitabine-based) for at least 3 months and achieved at least stable disease. The inclusion criteria are as follow: 1) histologically and cytologically confirmed advanced pancreatic ductal adenocarcinoma according to AJCC (American Joint Committee on Cancer) TNM system; 2) have undergone first-line of chemotherapy (modified FOLFIRINOX or gemcitabine-based) for at least 3 months and achieved at least stable disease; 3) Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0-2; 4) age above 18 ages and 5) life expectancy more than three months. Meanwhile, the exclusion criteria are 1) pregnant and lactating women; 2) concomitant beta-adrenergic drug blockers medication; 3) active infection; 4) current enrollment in another clinical study with an investigational agent and 5) patients who undergo pancreas or metastatic site radiotherapy need to be recovered from the toxicities.
Next, patients who achieve at least stable disease will be checked for peripheral blood mononuclear cells (PBMC) adequacy, hematoprofiling using full blood count (FBC) and their baseline status. This is followed by leukapheresis once all conditions satisfied and met. Apheretic products will be sent to local sponsor-contracted laboratory prior for incubation of patients' immune cells with PDAC antigens under specific medium.
All subjects in this trial have been diagnosed with advanced stage of PDAC and being treated with standard chemo: modified FOLFIRINOX or gemcitabine-based regime for at least 3 months. Once the DC+CIK infusion bags are ready to be manufactured, those who achieve at least stable disease or partial response will be randomized in ratio of 1:1 into treatment group: DC-CIK plus S1 (27 patients) and control group: S-1 alone (27 patients).
For treatment group, DC+CIK infusion bag will be administrated right after 17 days patients discharged. Patients will be infused with DC first, followed by CIK immune cells on day 1. DC+CIK immunotherapy will be repeated for another 2 times (day 8 and 15) as one cycle. All patients are left to rest for a week (start from day 21) prior to receive another 3 times of infusion (day 28, 35 and 42) if condition allowed. DC+CIK immunotherapy will be offered as two cycles for every patient in treatment group.
Additional third cycle can be performed on those who tolerate well with no toxicity or respond very well. Patients from treatment group will be assessed for their eligibility to receive booster dose on following conditions: 1) tumour achieves partial response or stable disease and 2) ECOG-PS performance status of 0-2 and 3) doesn't exhibit grade 1 and 2 toxicities to improve tumour control.
Additionally, S-1 will be given twice daily after meals for 2 weeks as first cycle along with DC+CIK. Next second cycle of S-1 will be given after 7-days (1 week) rest. The cycles will be repeated every 21 days until disease progression, unacceptable toxic effects, or withdrawal with consent. Dose of S-1 will be determined according to the body surface area.
Meanwhile, patients from control group will receive S-1 alone as maintenance therapy twice daily after meals for 14 days (2 weeks) as one cycle. The next cycle of S-1 will be given after 7-days rest. The cycles will be repeated every 21 days until disease progression, unacceptable toxic effects, or withdrawal with consent.
All patients will be followed up for clinical effects of S-1 combined maintenance therapy translated by tumour best overall response towards the treatment, either complete response (CR), partial response (PR), stable disease (SD) outcomes or progression disease (PD) and level of prognostic biomarkers. Besides, all patients will undergo baseline CT/MRI scan within 4 weeks of patient randomization and before immunotherapy being initiated. This is followed by reassessment CT/MRI scan at the end of 8th weeks starting from date of first treatment, and after S-1 combined DC+CIK immunotherapy completed. All patients will be followed-up regularly to monitor disease progression using reassessment CT/MRI scan at eight weeks interval until first PD observed (Timeframe = 12 months).
Patients' blood will be taken before maintenance treatment initiated and after maintenance treatment completed to evaluate serum cytokine concentration changes and level of circulating cancer stem cells (CSCs). Furthermore, blood will also be taken after each cycle of DC+CIK immunotherapy completed to evaluate baseline peripheral immune profile. Serum CA19-9 concentrations will be monitored every 4 weeks using blood test after first cycle of DC+CIK treatment completed.
Two endoscopic-ultrasound (EUS) guided biopsy pancreatic specimens (optional) will be collected from treatment group patients before maintenance treatment given and after completion of second cycle DC+CIK immunotherapy to quantify tumour-infiltrating lymphocytes (TILs), apoptotic protein expressed on tumour cells and apoptotic cells.
Finally, patients will be monitored for side effects, toxicities and response toward treatment weekly starting on day 7th onward after initial DC+CIK administration. All dated events occurring any time after informed consent will be obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Subjects who fulfill following inclusion criteria will be admitted to this phase 2 trial and will be excluded if they fulfill any one of the exclusion criteria. All patients must have undergone first-line of chemotherapy (either modified FOLFIRINOX or gemcitabine-based) for at least 3 months and achieved at least stable disease. The inclusion criteria are as follow: 1) histologically and cytologically confirmed advanced pancreatic ductal adenocarcinoma according to AJCC (American Joint Committee on Cancer) TNM system; 2) have undergone first-line of chemotherapy (modified FOLFIRINOX or gemcitabine-based) for at least 3 months and achieved at least stable disease; 3) Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0-2; 4) age above 18 ages and 5) life expectancy more than three months. Meanwhile, the exclusion criteria are 1) pregnant and lactating women; 2) concomitant beta-adrenergic drug blockers medication; 3) active infection; 4) current enrollment in another clinical study with an investigational agent and 5) patients who undergo pancreas or metastatic site radiotherapy need to be recovered from the toxicities.
Next, patients who achieve at least stable disease will be checked for peripheral blood mononuclear cells (PBMC) adequacy, hematoprofiling using full blood count (FBC) and their baseline status. This is followed by leukapheresis once all conditions satisfied and met. Apheretic products will be sent to local sponsor-contracted laboratory prior for incubation of patients' immune cells with PDAC antigens under specific medium.
All subjects in this trial have been diagnosed with advanced stage of PDAC and being treated with standard chemo: modified FOLFIRINOX or gemcitabine-based regime for at least 3 months. Once the DC+CIK infusion bags are ready to be manufactured, those who achieve at least stable disease or partial response will be randomized in ratio of 1:1 into treatment group: DC-CIK plus S1 (27 patients) and control group: S-1 alone (27 patients).
For treatment group, DC+CIK infusion bag will be administrated right after 17 days patients discharged. Patients will be infused with DC first, followed by CIK immune cells on day 1. DC+CIK immunotherapy will be repeated for another 2 times (day 8 and 15) as one cycle. All patients are left to rest for a week (start from day 21) prior to receive another 3 times of infusion (day 28, 35 and 42) if condition allowed. DC+CIK immunotherapy will be offered as two cycles for every patient in treatment group.
Additional third cycle can be performed on those who tolerate well with no toxicity or respond very well. Patients from treatment group will be assessed for their eligibility to receive booster dose on following conditions: 1) tumour achieves partial response or stable disease and 2) ECOG-PS performance status of 0-2 and 3) doesn't exhibit grade 1 and 2 toxicities to improve tumour control.
Additionally, S-1 will be given twice daily after meals for 2 weeks as first cycle along with DC+CIK. Next second cycle of S-1 will be given after 7-days (1 week) rest. The cycles will be repeated every 21 days until disease progression, unacceptable toxic effects, or withdrawal with consent. Dose of S-1 will be determined according to the body surface area.
Meanwhile, patients from control group will receive S-1 alone as maintenance therapy twice daily after meals for 14 days (2 weeks) as one cycle. The next cycle of S-1 will be given after 7-days rest. The cycles will be repeated every 21 days until disease progression, unacceptable toxic effects, or withdrawal with consent.
All patients will be followed up for clinical effects of S-1 combined maintenance therapy translated by tumour best overall response towards the treatment, either complete response (CR), partial response (PR), stable disease (SD) outcomes or progression disease (PD) and level of prognostic biomarkers. Besides, all patients will undergo baseline CT/MRI scan within 4 weeks of patient randomization and before immunotherapy being initiated. This is followed by reassessment CT/MRI scan at the end of 8th weeks starting from date of first treatment, and after S-1 combined DC+CIK immunotherapy completed. All patients will be followed-up regularly to monitor disease progression using reassessment CT/MRI scan at eight weeks interval until first PD observed (Timeframe = 12 months).
Patients' blood will be taken before maintenance treatment initiated and after maintenance treatment completed to evaluate serum cytokine concentration changes and level of circulating cancer stem cells (CSCs). Furthermore, blood will also be taken after each cycle of DC+CIK immunotherapy completed to evaluate baseline peripheral immune profile. Serum CA19-9 concentrations will be monitored every 4 weeks using blood test after first cycle of DC+CIK treatment completed.
Two endoscopic-ultrasound (EUS) guided biopsy pancreatic specimens (optional) will be collected from treatment group patients before maintenance treatment given and after completion of second cycle DC+CIK immunotherapy to quantify tumour-infiltrating lymphocytes (TILs), apoptotic protein expressed on tumour cells and apoptotic cells.
Finally, patients will be monitored for side effects, toxicities and response toward treatment weekly starting on day 7th onward after initial DC+CIK administration. All dated events occurring any time after informed consent will be obtained until 7 days (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.
Conditions
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Pancreatic Ductal Adenocarcinoma
Advanced Solid Tumor
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Caregivers
Study Groups
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Treatment Group
Receiving DC-CIK plus S1 maintenance treatment
Group Type
EXPERIMENTAL
Dendritic cell + Cytokine-induced killer cell (DC+CIK) immunotherapy
Intervention Type
BIOLOGICAL
DC+CIK immunotherapy will be administrated with S-1 chemo drug as maintenance treatment for patients with advanced PDAC
Tegafur Only Product
Intervention Type
DRUG
Tegafur (TS-1) will be administrated alone as maintenance treatment to control group as standard of care
Control Group
Receiving S-1 maintenance treatment alone
Group Type
ACTIVE_COMPARATOR
Tegafur Only Product
Intervention Type
DRUG
Tegafur (TS-1) will be administrated alone as maintenance treatment to control group as standard of care
Interventions
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Dendritic cell + Cytokine-induced killer cell (DC+CIK) immunotherapy
DC+CIK immunotherapy will be administrated with S-1 chemo drug as maintenance treatment for patients with advanced PDAC
Intervention Type
BIOLOGICAL
Tegafur Only Product
Tegafur (TS-1) will be administrated alone as maintenance treatment to control group as standard of care
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. Histologically and cytologically confirmed advanced pancreatic ductal adenocarcinoma according to AJCC (American Joint Committee on Cancer) TNM system;
2. Have undergone first-line of chemotherapy (modified FOLFIRINOX or gemcitabine-based) for at least 3 months and achieved at least stable disease;
3. Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0-2;
4. Age above 18 ages
5. Life expectancy more than three months.
2. Have undergone first-line of chemotherapy (modified FOLFIRINOX or gemcitabine-based) for at least 3 months and achieved at least stable disease;
3. Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0-2;
4. Age above 18 ages
5. Life expectancy more than three months.
Exclusion Criteria
1. Pregnant and lactating women
2. Concomitant beta-adrenergic drug blockers medication
3. Active infection
4. Current enrollment in another clinical study with an investigational agent
5. Patients who undergo radiotherapy to pancreas or metastatic site need to be recovered from the toxicities
2. Concomitant beta-adrenergic drug blockers medication
3. Active infection
4. Current enrollment in another clinical study with an investigational agent
5. Patients who undergo radiotherapy to pancreas or metastatic site need to be recovered from the toxicities
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Malaya
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Clinical Oncology Department, Ummc
Petaling Jaya, Kuala Lumpur, Malaysia
Site Status
RECRUITING
Countries
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Malaysia
Central Contacts
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Facility Contacts
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References
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Bear AS, Vonderheide RH, O'Hara MH. Challenges and Opportunities for Pancreatic Cancer Immunotherapy. Cancer Cell. 2020 Dec 14;38(6):788-802. doi: 10.1016/j.ccell.2020.08.004. Epub 2020 Sep 17.
Reference Type
BACKGROUND
Chen L, Zhang X. Primary analysis for clinical efficacy of immunotherapy in patients with pancreatic cancer. Immunotherapy. 2016 Feb;8(2):223-34. doi: 10.2217/imt.15.105. Epub 2015 Nov 13.
Reference Type
BACKGROUND
Du H, Yang J, Zhang Y. Cytokine-induced killer cell/dendritic cell combined with cytokine-induced killer cell immunotherapy for treating advanced gastrointestinal cancer. BMC Cancer. 2020 Apr 28;20(1):357. doi: 10.1186/s12885-020-06860-y.
Reference Type
BACKGROUND
Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
Reference Type
BACKGROUND
Foley K, Kim V, Jaffee E, Zheng L. Current progress in immunotherapy for pancreatic cancer. Cancer Lett. 2016 Oct 10;381(1):244-51. doi: 10.1016/j.canlet.2015.12.020. Epub 2015 Dec 23.
Reference Type
BACKGROUND
Gammaitoni L, Giraudo L, Leuci V, Todorovic M, Mesiano G, Picciotto F, Pisacane A, Zaccagna A, Volpe MG, Gallo S, Caravelli D, Giacone E, Venesio T, Balsamo A, Pignochino Y, Grignani G, Carnevale-Schianca F, Aglietta M, Sangiolo D. Effective activity of cytokine-induced killer cells against autologous metastatic melanoma including cells with stemness features. Clin Cancer Res. 2013 Aug 15;19(16):4347-58. doi: 10.1158/1078-0432.CCR-13-0061. Epub 2013 Jun 21.
Reference Type
BACKGROUND
Haag GM, Stocker G, Quidde J, Jaeger D, Lordick F. Randomized controlled trial of S-1 maintenance therapy in metastatic esophagogastric cancer - the multinational MATEO study. BMC Cancer. 2017 Jul 31;17(1):509. doi: 10.1186/s12885-017-3497-9.
Reference Type
BACKGROUND
He W, Huang Z, Zhou S, Huang L, Wang B, Zhu L, Ding Y, Yu YL, Zhang S. The effect of DC+CIK combined therapy on rat liver cancer model and its modulatory effect on immune functions. Eur Rev Med Pharmacol Sci. 2018 Feb;22(3):778-785. doi: 10.26355/eurrev_201802_14312.
Reference Type
BACKGROUND
Miller KD, Fidler-Benaoudia M, Keegan TH, Hipp HS, Jemal A, Siegel RL. Cancer statistics for adolescents and young adults, 2020. CA Cancer J Clin. 2020 Nov;70(6):443-459. doi: 10.3322/caac.21637. Epub 2020 Sep 17.
Reference Type
BACKGROUND
Pan CC, Huang ZL, Li W, Zhao M, Zhou QM, Xia JC, Wu PH. Serum alpha-fetoprotein measurement in predicting clinical outcome related to autologous cytokine-induced killer cells in patients with hepatocellular carcinoma undergone minimally invasive therapy. Chin J Cancer. 2010 Jun;29(6):596-602. doi: 10.5732/cjc.009.10580.
Reference Type
BACKGROUND
Sudo K, Nakamura K, Yamaguchi T. S-1 in the treatment of pancreatic cancer. World J Gastroenterol. 2014 Nov 7;20(41):15110-8. doi: 10.3748/wjg.v20.i41.15110.
Reference Type
BACKGROUND
Ueno H, Ioka T, Ikeda M, Ohkawa S, Yanagimoto H, Boku N, Fukutomi A, Sugimori K, Baba H, Yamao K, Shimamura T, Sho M, Kitano M, Cheng AL, Mizumoto K, Chen JS, Furuse J, Funakoshi A, Hatori T, Yamaguchi T, Egawa S, Sato A, Ohashi Y, Okusaka T, Tanaka M. Randomized phase III study of gemcitabine plus S-1, S-1 alone, or gemcitabine alone in patients with locally advanced and metastatic pancreatic cancer in Japan and Taiwan: GEST study. J Clin Oncol. 2013 May 1;31(13):1640-8. doi: 10.1200/JCO.2012.43.3680. Epub 2013 Apr 1.
Reference Type
BACKGROUND
Wang Z, Liu Y, Li R, Shang Y, Zhang Y, Zhao L, Li W, Yang Y, Zhang X, Yang T, Nie C, Han F, Liu Y, Luo S, Gao Q, Song Y. Autologous cytokine-induced killer cell transfusion increases overall survival in advanced pancreatic cancer. J Hematol Oncol. 2016 Feb 3;9:6. doi: 10.1186/s13045-016-0237-6.
Reference Type
BACKGROUND
Xie Y, Huang L, Chen L, Lin X, Chen L, Zheng Q. Effect of dendritic cell-cytokine-induced killer cells in patients with advanced colorectal cancer combined with first-line treatment. World J Surg Oncol. 2017 Nov 28;15(1):209. doi: 10.1186/s12957-017-1278-1.
Reference Type
BACKGROUND
Yuan X, Zhang AZ, Ren YL, Wang XL, Jiang CH, Yang L, Liu CX, Liang WH, Pang LJ, Gu WY, Li F, Hu JM. Cytokine-induced killer cells/dendritic cells and cytokine-induced killer cells immunotherapy for the treatment of esophageal cancer: A meta-analysis. Medicine (Baltimore). 2021 Apr 2;100(13):e24519. doi: 10.1097/MD.0000000000024519.
Reference Type
BACKGROUND
Zhu H, Yi C, Zhao Y, Gou H. Gemcitabine plus S-1 for metastatic pancreatic cancer. Medicine (Baltimore). 2018 Oct;97(41):e12836. doi: 10.1097/MD.0000000000012836.
Reference Type
BACKGROUND
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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DECIMATE 3.0
Identifier Type: -
Identifier Source: org_study_id
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