A Prospective Study of Anti-PD-1 Alone or Combined Wih Autologous DC-CIK Cell Therapy in Advanced Solid Tumors

Capital Medical University1 site in 1 country100 target enrollmentSeptember 2016

ConditionsNeoplasms

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Neoplasms
Sponsor: Capital Medical University
Enrollment: 100
Locations: 1
Primary Endpoint: Overall survival of the participants(OS)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2016

End Date

June 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Capital Medical University

Responsible Party

Principal Investigator

Jun Ren MD, PhD

MD， PhD

Capital Medical University

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
•Age 18 to
•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.

Outcomes

Primary Outcomes

Overall survival of the participants(OS)

Time Frame: 24 months

From starting date of anti-PD-1 antibody treatment until date of death from any cause

Secondary Outcomes

Treatment-related adverse events(24 months)
Progression-free survival of the participants(PFS)(24 months)
The changes in immune-response specific patient-reported outcomes(irPRO)(24 months)
The changes in patient self-reported quality of life(24 months)