Clinical trial NCT03190811: Anti-PD-1 Alone or Combined With Autologous DC-CIK Cell Therapy in Advanced Solid Tumors
Official title: A Prospective Study of Anti-PD-1 Alone or Combined Wih Autologous DC-CIK Cell Therapy in Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Neoplasms
Keywords: advanced solid tumor
DC-CIK
anti-PD-1 antibody
immunotherapy
Lead sponsor: Capital Medical University
Sponsor class: OTHER
Collaborators: name: Duke University
First posted: 2017-06-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the clinical efficacy and toxicity of anti-PD-1 monoclonal antibody alone with anti-PD-1 monoclonal antibody plus autologous dendritic cells-cytokine induced killer cell (DC-CIK) immunotherapy in advanced tumor patients.Furthermore,to characterize response to therapy we intent to evaluate the role of cell-free DNA (cfDNA) and immune repertoire based on the next generation sequencing.


Eligibility criteria: Inclusion Criteria:

* Histological confirmed advanced or metastatic solid tumors (lung cancer, gastric cancer, renal cancer, bladder cancer, breast cancer, pancreatic cancer, others).
* Patients must have received previously standard therapy for that malignancy or declined to chemotherapy/radiotherapy.
* Estimated life expectancy \> 3 months.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
* Age 18 to 80.
* Adequate hematologic function, with WBC ≥ 3000/microliter, hemoglobin ≥ 9 g/dL (it is acceptable to have had prior transfusion), platelets ≥ 75,000/microliter; PT-INR \<1.5 (unless patient is receiving warfarin in which case PT-INR must be \<3), PTT \<1.5X ULN
* Adequate renal and hepatic function, with serum creatinine \< 1.5 mg/dL, bilirubin \< 1.5 mg/dL (except for Gilbert's syndrome which will allow bilirubin ≤ 2.0 mg/dL), ALT and AST ≤ 2.5 x upper limit of normal.

Exclusion Criteria:

* Patients with a history of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. Autoimmune related thyroid disease and vitiligo are permitted.
* Patients with serious intercurrent chronic or acute illness, such as cardiac disease (NYHA class III or IV), hepatic disease, or other illness considered by the Principal Investigator as unwarranted high risk for investigational drug treatment.
* Patients with a medical or psychological impediment to probable compliance with the protocol should be excluded.
* Concurrent (or within the last 5 years) second malignancy other than non melanoma skin cancer, cervical carcinoma in situ, controlled superficial bladder cancer, or other carcinoma in situ that has been treated.
* Presence of an active acute or chronic infection including: a urinary tract infection, HIV (as determined by ELISA and confirmed by Western Blot). Patients with HIV are excluded based on immuno-suppression, which may render them unable to respond to the vaccine; patients with chronic hepatitis are excluded because of concern that hepatitis could be exacerbated by the injections.
* Patients on chronic steroid therapy (or other immuno-suppressives, such as azathioprine or cyclosporin A) are excluded on the basis of potential immune suppression. Patients must have had 6 weeks of discontinuation of any steroid therapy (except that used as pre-medication for chemotherapy or contrast-enhanced studies or for acute treatment (\<5 days) of intercurrent medical condition such as a gout flare) prior to enrollment.
* Pregnant and nursing women should be excluded from the protocol since this research may have unknown and harmful effects on an unborn child or on young children. If the patient is sexually active, the patient must agree to use a medically acceptable form of birth control while receiving treatment and for a period of 4 months following the last vaccination therapy. It is not known whether the treatment used in this study could affect the sperm and could potentially harm a child that may be fathered while on this study.
* Patients with acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions will be excluded.

Primary outcomes:
measure: Overall survival of the participants(OS)
timeFrame: 24 months
Secondary outcomes:
measure: Progression-free survival of the participants(PFS)
timeFrame: 24 months
measure: The changes in immune-response specific patient-reported outcomes(irPRO)
timeFrame: 24 months
measure: Treatment-related adverse events
timeFrame: 24 months
measure: The changes in patient self-reported quality of life
timeFrame: 24 months
Other outcomes:
measure: Exploratory biomarkers
timeFrame: 24 months
Locations:
city: Beijing
country: China
facility: Capital Medical University Cancer Center/Beijing Shijitan Hospital
state: Beijing
Study officials:
References: