Phase 2
Completed N=170
SBRT Plus Pembrolizumab and Trametinib for Pancreatic Cancer
Source: ClinicalTrials.gov NCT02704156 ↗Enrolled (actual)
170
Serious AEs
29.4%
Results posted
Feb 2021
Primary outcomePrimary: The Median Survival Time Will be Determined. — 12.8; 14.9 months
Summary
Hypothesis: Survival benefits could be found in SBRT Plus Pembrolizumab and Trametinib compared with SBRT plus gemcitabine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Median Survival Time Will be Determined. |
12.8; 14.9 | — |
| SECONDARY One- and Two-year Overall Survival Rate Will be Determined. |
48; 53; 0; 2 | — |
| SECONDARY Treatment-related Adverse Effects Will be Determined. |
0; 2; 2; 1; 6; 10 | — |
| SECONDARY The Median Progression Free Survival Time Will be Determined. |
5.4; 8.2 | — |
| SECONDARY One- and Two-year Progression Survival Rate Will be Determined. Will be Determined. |
7; 18; 0; 0 | — |
| SECONDARY The Quality of Life Will be Analyzed. |
86.2; 83.7; 81.8; 84.5; 73.9; 72.1 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
- Inability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document.
Data sourced from ClinicalTrials.gov (NCT02704156). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.