SBRT Plus Pembrolizumab and Trametinib for Pancreatic Cancer

NCT02704156 | Completed Phase 2 Results

• 1 other identifier: ChanghaiHosp
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis: Survival benefits could be found in SBRT Plus Pembrolizumab and Trametinib compared with SBRT plus gemcitabine.

Conditions

Pancreatic Cancer

Keywords

Stereotactic body radiation therapy; CyberKnife; Initial treatment

Outcome Measures

Primary Outcomes (1)

• The Median Survival Time Will be Determined.

  The time from the start of treatment to death

  3 years

Secondary Outcomes (5)

• One- and Two-year Overall Survival Rate Will be Determined.

  2 year

• Treatment-related Adverse Effects Will be Determined.

  3 years

• The Median Progression Free Survival Time Will be Determined.

  3 years

• One- and Two-year Progression Survival Rate Will be Determined. Will be Determined.

  2 years

• The Quality of Life Will be Analyzed.

  3 years

Study Arms (2)

SBRT plus Pembrolizumab and Trametinib

EXPERIMENTAL

Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.

Device: Cyberknife plus Pembrolizumab and Trametinib

SBRT plus Gemcitabine

ACTIVE COMPARATOR

Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.

Device: Cyberknife plus Gemcitabine

Interventions

Cyberknife plus Pembrolizumab and Trametinib DEVICE

Radiation therapy plus drug

SBRT plus Pembrolizumab and Trametinib

Cyberknife plus Gemcitabine DEVICE

Radiation therapy plus drug

SBRT plus Gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed pancreatic ductal adenocarcinoma with unequivocal first progression after surgery followed by chemotherapy
• Without any immunotherapy or targeted therapy
• A life expectancy of \>3months
• ECOG of 0 to1
• Age of 18 years or older
• Analysis of surgical specimens showed KRAS mutations and positive immunohistochemical staining of PD-L1
• 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
• 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)
• INR \< 2 (0.9-1.1)
• Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Prior immunotherapy or targeted therapy
• Evidences of metastatic disease confirmed by chest CT or FDG PET-CT
• Contraindication to receiving immunotherapy, targeted therapy or SBRT
• ECOG ≥2
• Age \<18 years
• Analysis of surgical specimens showed KRAS wild type or negative immunohistochemical staining of PD-L1
• Secondary malignancy
• Abnormal results of blood routine examinations and liver and kidney and coagulation tests
• Patients with active inflammatory bowel diseases or peptic ulcer
• Gastrointestinal bleeding or perforation within 6 months
• Heart failure: NYHA III-IV
• Respiratory insufficiency
• Women who are pregnant
• Participation in another clinical treatment trial while on study
• Patients in whom fiducial implantation was not possible

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (16)

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• 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.

  PMID: 36471691 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.

  PMID: 35240087 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.

  PMID: 34237249 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Limitations and Caveats

The major limitation of the study was the small number of the randomized patients.

Results Point of Contact

• Title: Huojun Zhang
• Organization: Changhai Hospital affiliated to Naval Medical University

chyyzhj@163.com

86-021-31162207

Study Officials

• Huo Jun Zhang, MD., PH.D

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Radiation Oncology Department

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: March 9, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 13, 2022
• Results First Posted: February 16, 2021

Record last verified: 2022-02

Locations

CN (1)