Clinical trial · Interventional
SBRT Plus Pembrolizumab and Trametinib for Pancreatic Cancer
Stereotactic Body Radiation Therapy Plus Pembrolizumab and Trametinib vs. Stereotactic Body Radiation Therapy Plus Gemcitabine for Locally Recurrent Pancreatic Cancer After Surgical Resection: an Open-label, Randomized, Controlled, Phase 2 Trial
NCT02704156CI-TRIAL-00058485completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Hypothesis: Survival benefits could be found in SBRT Plus Pembrolizumab and Trametinib compared with SBRT plus gemcitabine.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyberknife plus Gemcitabine | Device | — | UNRESOLVED |
| Cyberknife plus Pembrolizumab and Trametinib | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SBRT plus Pembrolizumab and Trametinib
- description
- Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.
- interventionNames
- Device: Cyberknife plus Pembrolizumab and Trametinib
- type
- ACTIVE_COMPARATOR
- label
- SBRT plus Gemcitabine
- description
- Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine.
- interventionNames
- Device: Cyberknife plus Gemcitabine
Primary outcomes (1)
- measure
- The Median Survival Time Will be Determined.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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. 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.
References
Publications (16)
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