SBRT Plus Pembrolizumab and Trametinib for Pancreatic Cancer
NCT ID: NCT02704156
Last Updated: 2022-05-13
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
170 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-10-31
Study Completion Date
2020-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Hypothesis: Survival benefits could be found in SBRT Plus Pembrolizumab and Trametinib compared with SBRT plus gemcitabine.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
SBRT Plus vNKT for Pancreatic Cancer
NCT05783076
Pancreatic Cancer
UNKNOWN
PHASE2
Borderline Resectable Pancreatic Cancer Neoadjuvant Chemoradiotherapy Clinicaltrial-1
NCT03777462
Pancreatic Cancer
UNKNOWN
PHASE2
Combination of SBRT With Sequential S-1 for Treating Locally Advanced Pancreatic Cancer
NCT02704143
Pancreatic Cancer
COMPLETED
NA
Phase 2 Trial of Gemcitabine vs S-1 vs Gemcitabine Plus Nab-paclitaxel as Adjuvant Chemotherapy of Post-operative Pancreatic Cancer Patients
NCT03278015
Cancer of Pancreas
UNKNOWN
PHASE2
Phase ǀ Study on Pancreatic Cancer Treated by CyberKnife
NCT02716207
Pancreatic Tumor
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Background and aim:
Pancreatic cancer is one of the most lethal malignancies and fourth leading cause of cancer death in both genders in US, where the mortality and incidence increase over the past decade with a lowest 5-year survival rate of 9% among all cancers. Although surgical resection is deemed to provide long-term disease control, only 20% patients were candidates for upfront surgery and unfortunately, even when adjuvant chemotherapy is prescribed, about 50% of patients will suffer local recurrence. Despite of emergence of immunotherapy as a new treatment paradigm, little improvement of outcomes has been found in pancreatic cancer. This may be ascribed to its inherent genetic mutations and immunosuppressive microenvironment. It has been demonstrated that radiotherapy could enhance the release and uptake of tumor-associated antigens, thus promoting antitumor T cell priming, and enhancing access to tumors due to effects both on the tumor vasculature and the chemokine milieu.
Despite of emergence of immune checkpoint inhibitors as a novel treatment paradigm for cancers, the results of investigations about the efficacy of immunotherapy alone for pancreatic cancer was disappointing. Due to enhanced immunogenicity of tumor irradiation, the underlying rationale of combination of radiotherapy and immunotherapy is that radiation can noninvasively prime the immune system against tumor cells, where antigen presentation and co-stimulation are facilitated, thus creating immune responses against previously hidden epitopes that are shared among distant metastases, while immune checkpoint inhibitors can reverse the immunosuppressive effects of the tumor microenvironment, thus facilitating antitumor immunity.
Although oncogenic mutations in KRAS are frequent in pancreatic cancer, KRAS proteins are difficult to be targeted due to high affinity for GTP and/or GDP. Therefore, efforts have been made to develop therapies targeting the major downstream effector pathways, which include the RAS-RAF-MEK-ERK and PI3K-PDPK1-AKT signaling pathways. MEK inhibitor trametinib alone or in combinations with chemotherapy or autophagy inhibitor hydroxychloroquine may probably have positive effects on tumor regression.
Regarding local recurrence after surgery, it was recommended that chemotherapy with optional radiotherapy may be the first-line treatment without addition of targeted therapy or immunotherapy owing to that no studies have investigated the efficacy of this regimen. Therefore, the aim of our study was to compare the outcomes between stereotactic body radiation therapy (SBRT) with pembrolizumab and trametinib and SBRT with gemcitabine for locally recurrent pancreatic cancer after surgical resection.
Study procedure:
1. All surgical specimens underwent immunohistochemical staining of PD-L1, classified as TC3 ≥ 50% or TC2 ≥ 5% but \< 50% or TC1 ≥ 1% but \<5% and IC3 ≥ 10% or IC2 ≥ 5% but \< 10% or IC1 ≥ 1% but \<5%.
2. KRAS mutations were analyzed by PCR amplification and direct sequencing of exon 2. Restriction Length Fragment Polymorphism method was used for further confirmation.
3. In the SBRT plus pembrolizumab and trametinib group, 200mg pembrolizumab was administered intravenously every 3 weeks and 2mg trametinib was given orally once daily.
4. In the SBRT plus gemcitabine group, patients received intravenous gemcitabine (1000mg/m2) on day 1 and 8 of each 21-day cycle for eight cycles in the absence of disease progression.
5. The prescribed dose of SBRT varies from 35-40Gy/5f with a single dose of 7-8Gy.
Pancreatic cancer is one of the most lethal malignancies and fourth leading cause of cancer death in both genders in US, where the mortality and incidence increase over the past decade with a lowest 5-year survival rate of 9% among all cancers. Although surgical resection is deemed to provide long-term disease control, only 20% patients were candidates for upfront surgery and unfortunately, even when adjuvant chemotherapy is prescribed, about 50% of patients will suffer local recurrence. Despite of emergence of immunotherapy as a new treatment paradigm, little improvement of outcomes has been found in pancreatic cancer. This may be ascribed to its inherent genetic mutations and immunosuppressive microenvironment. It has been demonstrated that radiotherapy could enhance the release and uptake of tumor-associated antigens, thus promoting antitumor T cell priming, and enhancing access to tumors due to effects both on the tumor vasculature and the chemokine milieu.
Despite of emergence of immune checkpoint inhibitors as a novel treatment paradigm for cancers, the results of investigations about the efficacy of immunotherapy alone for pancreatic cancer was disappointing. Due to enhanced immunogenicity of tumor irradiation, the underlying rationale of combination of radiotherapy and immunotherapy is that radiation can noninvasively prime the immune system against tumor cells, where antigen presentation and co-stimulation are facilitated, thus creating immune responses against previously hidden epitopes that are shared among distant metastases, while immune checkpoint inhibitors can reverse the immunosuppressive effects of the tumor microenvironment, thus facilitating antitumor immunity.
Although oncogenic mutations in KRAS are frequent in pancreatic cancer, KRAS proteins are difficult to be targeted due to high affinity for GTP and/or GDP. Therefore, efforts have been made to develop therapies targeting the major downstream effector pathways, which include the RAS-RAF-MEK-ERK and PI3K-PDPK1-AKT signaling pathways. MEK inhibitor trametinib alone or in combinations with chemotherapy or autophagy inhibitor hydroxychloroquine may probably have positive effects on tumor regression.
Regarding local recurrence after surgery, it was recommended that chemotherapy with optional radiotherapy may be the first-line treatment without addition of targeted therapy or immunotherapy owing to that no studies have investigated the efficacy of this regimen. Therefore, the aim of our study was to compare the outcomes between stereotactic body radiation therapy (SBRT) with pembrolizumab and trametinib and SBRT with gemcitabine for locally recurrent pancreatic cancer after surgical resection.
Study procedure:
1. All surgical specimens underwent immunohistochemical staining of PD-L1, classified as TC3 ≥ 50% or TC2 ≥ 5% but \< 50% or TC1 ≥ 1% but \<5% and IC3 ≥ 10% or IC2 ≥ 5% but \< 10% or IC1 ≥ 1% but \<5%.
2. KRAS mutations were analyzed by PCR amplification and direct sequencing of exon 2. Restriction Length Fragment Polymorphism method was used for further confirmation.
3. In the SBRT plus pembrolizumab and trametinib group, 200mg pembrolizumab was administered intravenously every 3 weeks and 2mg trametinib was given orally once daily.
4. In the SBRT plus gemcitabine group, patients received intravenous gemcitabine (1000mg/m2) on day 1 and 8 of each 21-day cycle for eight cycles in the absence of disease progression.
5. The prescribed dose of SBRT varies from 35-40Gy/5f with a single dose of 7-8Gy.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Pancreatic Cancer
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SBRT plus Pembrolizumab and Trametinib
Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.
Group Type
EXPERIMENTAL
Cyberknife plus Pembrolizumab and Trametinib
Intervention Type
DEVICE
Radiation therapy plus drug
SBRT plus Gemcitabine
Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.
Group Type
ACTIVE_COMPARATOR
Cyberknife plus Gemcitabine
Intervention Type
DEVICE
Radiation therapy plus drug
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cyberknife plus Pembrolizumab and Trametinib
Radiation therapy plus drug
Intervention Type
DEVICE
Cyberknife plus Gemcitabine
Radiation therapy plus drug
Intervention Type
DEVICE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Histologically confirmed pancreatic ductal adenocarcinoma with unequivocal first progression after surgery followed by chemotherapy
2. Without any immunotherapy or targeted therapy
3. A life expectancy of \>3months
4. ECOG of 0 to1
5. Age of 18 years or older
6. Analysis of surgical specimens showed KRAS mutations and positive immunohistochemical staining of PD-L1
7. Blood routine examination: Absolute neutrophil count (ANC) ≥ 1.5 ×109 cells/L, leukocyte count≥ 3.5 ×109 cells/L, platelets ≥ 70×109 cells/L, hemoglobin ≥ 8.0 g/dl
8. Liver and kidney function tests: Albumin \> 2.5 g/dL, total bilirubin \< 3 mg/dL, creatinine \< 2.0 mg/dL, AST\<2.5 × ULN(Upper Limit of Normal)(0-64U/L), ALT\<2.5 × ULN(0-64U/L)
9. INR \< 2 (0.9-1.1)
10. Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document.
2. Without any immunotherapy or targeted therapy
3. A life expectancy of \>3months
4. ECOG of 0 to1
5. Age of 18 years or older
6. Analysis of surgical specimens showed KRAS mutations and positive immunohistochemical staining of PD-L1
7. Blood routine examination: Absolute neutrophil count (ANC) ≥ 1.5 ×109 cells/L, leukocyte count≥ 3.5 ×109 cells/L, platelets ≥ 70×109 cells/L, hemoglobin ≥ 8.0 g/dl
8. Liver and kidney function tests: Albumin \> 2.5 g/dL, total bilirubin \< 3 mg/dL, creatinine \< 2.0 mg/dL, AST\<2.5 × ULN(Upper Limit of Normal)(0-64U/L), ALT\<2.5 × ULN(0-64U/L)
9. INR \< 2 (0.9-1.1)
10. Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
1. Prior immunotherapy or targeted therapy
2. Evidences of metastatic disease confirmed by chest CT or FDG PET-CT
3. Contraindication to receiving immunotherapy, targeted therapy or SBRT
4. ECOG ≥2
5. Age \<18 years
6. Analysis of surgical specimens showed KRAS wild type or negative immunohistochemical staining of PD-L1
7. Secondary malignancy
8. Abnormal results of blood routine examinations and liver and kidney and coagulation tests
9. Patients with active inflammatory bowel diseases or peptic ulcer
10. Gastrointestinal bleeding or perforation within 6 months
11. Heart failure: NYHA III-IV
12. Respiratory insufficiency
13. Women who are pregnant
14. Participation in another clinical treatment trial while on study
15. Patients in whom fiducial implantation was not possible
16. Inability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document.
2. Evidences of metastatic disease confirmed by chest CT or FDG PET-CT
3. Contraindication to receiving immunotherapy, targeted therapy or SBRT
4. ECOG ≥2
5. Age \<18 years
6. Analysis of surgical specimens showed KRAS wild type or negative immunohistochemical staining of PD-L1
7. Secondary malignancy
8. Abnormal results of blood routine examinations and liver and kidney and coagulation tests
9. Patients with active inflammatory bowel diseases or peptic ulcer
10. Gastrointestinal bleeding or perforation within 6 months
11. Heart failure: NYHA III-IV
12. Respiratory insufficiency
13. Women who are pregnant
14. Participation in another clinical treatment trial while on study
15. Patients in whom fiducial implantation was not possible
16. Inability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Changhai Hospital
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zhang Huo Jun
Director of Radiation Oncology Department
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Huo Jun Zhang, MD., PH.D
Role: PRINCIPAL_INVESTIGATOR
Changhai Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Changhai hospital
Shanghai, Shanghai Municipality, China
Site Status
Countries
Review the countries where the study has at least one active or historical site.
China
References
Explore related publications, articles, or registry entries linked to this study.
Siegel RL, Miller KD, Goding Sauer A, Fedewa SA, Butterly LF, Anderson JC, Cercek A, Smith RA, Jemal A. Colorectal cancer statistics, 2020. CA Cancer J Clin. 2020 May;70(3):145-164. doi: 10.3322/caac.21601. Epub 2020 Mar 5.
Reference Type
BACKGROUND
Oettle H, Neuhaus P, Hochhaus A, Hartmann JT, Gellert K, Ridwelski K, Niedergethmann M, Zulke C, Fahlke J, Arning MB, Sinn M, Hinke A, Riess H. Adjuvant chemotherapy with gemcitabine and long-term outcomes among patients with resected pancreatic cancer: the CONKO-001 randomized trial. JAMA. 2013 Oct 9;310(14):1473-81. doi: 10.1001/jama.2013.279201.
Reference Type
BACKGROUND
Dewan MZ, Galloway AE, Kawashima N, Dewyngaert JK, Babb JS, Formenti SC, Demaria S. Fractionated but not single-dose radiotherapy induces an immune-mediated abscopal effect when combined with anti-CTLA-4 antibody. Clin Cancer Res. 2009 Sep 1;15(17):5379-88. doi: 10.1158/1078-0432.CCR-09-0265. Epub 2009 Aug 25.
Reference Type
BACKGROUND
Verbrugge I, Hagekyriakou J, Sharp LL, Galli M, West A, McLaughlin NM, Duret H, Yagita H, Johnstone RW, Smyth MJ, Haynes NM. Radiotherapy increases the permissiveness of established mammary tumors to rejection by immunomodulatory antibodies. Cancer Res. 2012 Jul 1;72(13):3163-74. doi: 10.1158/0008-5472.CAN-12-0210. Epub 2012 May 8.
Reference Type
BACKGROUND
Royal RE, Levy C, Turner K, Mathur A, Hughes M, Kammula US, Sherry RM, Topalian SL, Yang JC, Lowy I, Rosenberg SA. Phase 2 trial of single agent Ipilimumab (anti-CTLA-4) for locally advanced or metastatic pancreatic adenocarcinoma. J Immunother. 2010 Oct;33(8):828-33. doi: 10.1097/CJI.0b013e3181eec14c.
Reference Type
BACKGROUND
Brahmer JR, Tykodi SS, Chow LQ, Hwu WJ, Topalian SL, Hwu P, Drake CG, Camacho LH, Kauh J, Odunsi K, Pitot HC, Hamid O, Bhatia S, Martins R, Eaton K, Chen S, Salay TM, Alaparthy S, Grosso JF, Korman AJ, Parker SM, Agrawal S, Goldberg SM, Pardoll DM, Gupta A, Wigginton JM. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med. 2012 Jun 28;366(26):2455-65. doi: 10.1056/NEJMoa1200694. Epub 2012 Jun 2.
Reference Type
BACKGROUND
Chakraborty M, Abrams SI, Coleman CN, Camphausen K, Schlom J, Hodge JW. External beam radiation of tumors alters phenotype of tumor cells to render them susceptible to vaccine-mediated T-cell killing. Cancer Res. 2004 Jun 15;64(12):4328-37. doi: 10.1158/0008-5472.CAN-04-0073.
Reference Type
BACKGROUND
Bailey P, Chang DK, Nones K, Johns AL, Patch AM, Gingras MC, Miller DK, Christ AN, Bruxner TJ, Quinn MC, Nourse C, Murtaugh LC, Harliwong I, Idrisoglu S, Manning S, Nourbakhsh E, Wani S, Fink L, Holmes O, Chin V, Anderson MJ, Kazakoff S, Leonard C, Newell F, Waddell N, Wood S, Xu Q, Wilson PJ, Cloonan N, Kassahn KS, Taylor D, Quek K, Robertson A, Pantano L, Mincarelli L, Sanchez LN, Evers L, Wu J, Pinese M, Cowley MJ, Jones MD, Colvin EK, Nagrial AM, Humphrey ES, Chantrill LA, Mawson A, Humphris J, Chou A, Pajic M, Scarlett CJ, Pinho AV, Giry-Laterriere M, Rooman I, Samra JS, Kench JG, Lovell JA, Merrett ND, Toon CW, Epari K, Nguyen NQ, Barbour A, Zeps N, Moran-Jones K, Jamieson NB, Graham JS, Duthie F, Oien K, Hair J, Grutzmann R, Maitra A, Iacobuzio-Donahue CA, Wolfgang CL, Morgan RA, Lawlor RT, Corbo V, Bassi C, Rusev B, Capelli P, Salvia R, Tortora G, Mukhopadhyay D, Petersen GM; Australian Pancreatic Cancer Genome Initiative; Munzy DM, Fisher WE, Karim SA, Eshleman JR, Hruban RH, Pilarsky C, Morton JP, Sansom OJ, Scarpa A, Musgrove EA, Bailey UM, Hofmann O, Sutherland RL, Wheeler DA, Gill AJ, Gibbs RA, Pearson JV, Waddell N, Biankin AV, Grimmond SM. Genomic analyses identify molecular subtypes of pancreatic cancer. Nature. 2016 Mar 3;531(7592):47-52. doi: 10.1038/nature16965. Epub 2016 Feb 24.
Reference Type
BACKGROUND
McCormick F. KRAS as a Therapeutic Target. Clin Cancer Res. 2015 Apr 15;21(8):1797-801. doi: 10.1158/1078-0432.CCR-14-2662.
Reference Type
BACKGROUND
Eser S, Schnieke A, Schneider G, Saur D. Oncogenic KRAS signalling in pancreatic cancer. Br J Cancer. 2014 Aug 26;111(5):817-22. doi: 10.1038/bjc.2014.215. Epub 2014 Apr 22.
Reference Type
BACKGROUND
Vena F, Li Causi E, Rodriguez-Justo M, Goodstal S, Hagemann T, Hartley JA, Hochhauser D. The MEK1/2 Inhibitor Pimasertib Enhances Gemcitabine Efficacy in Pancreatic Cancer Models by Altering Ribonucleotide Reductase Subunit-1 (RRM1). Clin Cancer Res. 2015 Dec 15;21(24):5563-77. doi: 10.1158/1078-0432.CCR-15-0485. Epub 2015 Jul 30.
Reference Type
BACKGROUND
Kinsey CG, Camolotto SA, Boespflug AM, Guillen KP, Foth M, Truong A, Schuman SS, Shea JE, Seipp MT, Yap JT, Burrell LD, Lum DH, Whisenant JR, Gilcrease GW 3rd, Cavalieri CC, Rehbein KM, Cutler SL, Affolter KE, Welm AL, Welm BE, Scaife CL, Snyder EL, McMahon M. Protective autophagy elicited by RAF-->MEK-->ERK inhibition suggests a treatment strategy for RAS-driven cancers. Nat Med. 2019 Apr;25(4):620-627. doi: 10.1038/s41591-019-0367-9. Epub 2019 Mar 4.
Reference Type
BACKGROUND
Bryant KL, Stalnecker CA, Zeitouni D, Klomp JE, Peng S, Tikunov AP, Gunda V, Pierobon M, Waters AM, George SD, Tomar G, Papke B, Hobbs GA, Yan L, Hayes TK, Diehl JN, Goode GD, Chaika NV, Wang Y, Zhang GF, Witkiewicz AK, Knudsen ES, Petricoin EF 3rd, Singh PK, Macdonald JM, Tran NL, Lyssiotis CA, Ying H, Kimmelman AC, Cox AD, Der CJ. Combination of ERK and autophagy inhibition as a treatment approach for pancreatic cancer. Nat Med. 2019 Apr;25(4):628-640. doi: 10.1038/s41591-019-0368-8. Epub 2019 Mar 4.
Reference Type
BACKGROUND
Zhu X, Liu W, Cao Y, Ju X, Zhao X, Jiang L, Ye Y, Zhang H. Effect of stereotactic body radiotherapy dose escalation plus pembrolizumab and trametinib versus stereotactic body radiotherapy dose escalation plus gemcitabine for locally recurrent pancreatic cancer after surgical resection on survival outcomes: A secondary analysis of an open-label, randomised, controlled, phase 2 trial. EClinicalMedicine. 2022 Dec 1;55:101764. doi: 10.1016/j.eclinm.2022.101764. eCollection 2023 Jan.
Reference Type
DERIVED
Zhu X, Cao Y, Liu W, Ju X, Zhao X, Jiang L, Ye Y, Jin G, Zhang H. Stereotactic body radiotherapy plus pembrolizumab and trametinib versus stereotactic body radiotherapy plus gemcitabine for locally recurrent pancreatic cancer after surgical resection: an open-label, randomised, controlled, phase 2 trial. Lancet Oncol. 2022 Mar;23(3):e105-e115. doi: 10.1016/S1470-2045(22)00066-3.
Reference Type
DERIVED
Zhu X, Cao Y, Liu W, Ju X, Zhao X, Jiang L, Ye Y, Jin G, Zhang H. Stereotactic body radiotherapy plus pembrolizumab and trametinib versus stereotactic body radiotherapy plus gemcitabine for locally recurrent pancreatic cancer after surgical resection: an open-label, randomised, controlled, phase 2 trial. Lancet Oncol. 2021 Aug;22(8):1093-1102. doi: 10.1016/S1470-2045(21)00286-2. Epub 2021 Jul 5.
Reference Type
DERIVED
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ChanghaiHosp
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Study of Stereotactic Body Radiation Therapy for Patients After Radical Resection of Pancreatic Cancer With Advanced Stages (T3 or N1)
NCT02461836
UNKNOWN
PHASE2
Role of Cyberknife Stereotactic Radiation Therapy (SBRT) Followed by Gemcitabine for Patients With Locally Advanced Pancreatic Cancer
NCT01304160
COMPLETED
PHASE1/PHASE2
Split-course SBRT for Borderline Resectable and Locally Advanced Pancreatic Cancer
NCT04289792
UNKNOWN
PHASE2
SBRT and Anti-programmed Cell Death Protein 1(Anti-PD-1) in Late Stage or Recurrent Pancreatic Cancer Patients
NCT03716596
TERMINATED
PHASE1
Re-irradiation With Stereotactic Body Radiotherapy for Relapsed Pancreatic Cancer
NCT02745847
UNKNOWN
NA
Study of Gemcitabine Plus Nab-paclitaxel Versus S1 Plus Nab-paclitaxel in Metastatic Adenocarcinoma of the Pancreas
NCT03779464
UNKNOWN
PHASE2
Chemoradiotherapy With Gemcitabine/S-1 vs Gemcitabine/S-1 for Locally Advanced Pancreatic Cancer
NCT01430052
COMPLETED
PHASE2
SBRT Combined With Nimotuzumab and Mono-chemotherapy in Locally Advanced Pancreatic Cancer
NCT06422156
NOT_YET_RECRUITING
PHASE2
Iparomlimab and Tuvonralimab Combined With GC in Advanced ICC
NCT07152769
NOT_YET_RECRUITING
PHASE2
Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes
NCT02754180
UNKNOWN
PHASE2
Pembrolizumab Plus Chemotherapy in 1st Line Treatment of Pancreatic Cancer
NCT04447092
ACTIVE_NOT_RECRUITING
PHASE2
Nimotuzumab Combined With Nab-paclitaxel/Gemcitabine in the Perioperative Treatment of High-risk Resectable/Borderline Resectable Pancreatic Cancer
NCT06781086
WITHDRAWN
PHASE2
Tunlametinib + AG + Cetuximab β as First-Line Therapy for Advanced Pancreatic Cancer
NCT07302841
NOT_YET_RECRUITING
PHASE4
Stereotactic Radiotherapy in Locally Advanced Pancreatic Cancer With Different Biological Effective Doses
NCT04603586
COMPLETED
NA
A Study of Chemoradiotherapy Using Gem Plus Nab-paclitaxel for Pancreatic Cancer
NCT02272738
COMPLETED
PHASE1
Albumin-Bound Paclitaxel and Gemcitabine With or Without S-1 as First-Line Treatment for Advanced Pancreatic Cancer
NCT06789679
RECRUITING
PHASE2
Evaluation of SBRT for Patients With Locally Advanced Unresectable Pancreatic Cancer
NCT03158779
COMPLETED
PHASE2
IORT Followed by CCRT or SBRT for Locally Advanced Pancreatic Cancer
NCT02734680
UNKNOWN
NA
Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC
NCT03257033
RECRUITING
PHASE3
A Study of GnP RegimenCombined With Serplulimab and Stereotactic Body Radiation Therapy as First-line Treatment for Locally Advanced Pancreatic Cancer
NCT07101679
RECRUITING
PHASE2
IN10018+ Standard Chemotherapy (+KN046) in Subjects With Advanced Pancreatic Cancer
NCT05827796
RECRUITING
PHASE1/PHASE2
Neoadjuvant Chemoradiation in Patients With Borderline Resectable Pancreatic Cancer
NCT01458717
COMPLETED
PHASE2/PHASE3
Gemcitabine With or Without Radiation Therapy in Treating Patients With Pancreatic Cancer
NCT00057876
COMPLETED
PHASE3
Neoadjuvant/Adjuvant Sintilimab, Nab-paclitaxel, and Gemcitabine for Resectable/Borderline Resectable Pancreatic Cancer
NCT05562297
NOT_YET_RECRUITING
PHASE2
Testing the Combination of Two Approved Chemotherapy Drugs and Radiation Prior to Surgery in Localized Pancreatic Cancer
NCT03492671
RECRUITING
PHASE2