It is a non-randomized pilot study.The allocation will be determined by patients or their immediate family members who were cooperative with physician's interpretations on the disease progression and updated information of cutting of edge treatment, the financial affordability, availability of treatment plans, possible tolerance or risks etc.The purpose of this study is to investigate the clinical efficacy and toxicity of autologous cellular immunotherapy combined with hyperthermia in abdominal and pelvic malignancies or metastases patients. Furthermore, to characterize response to different regimens,the investigators intent to explore the predictive and prognostic biomarker, as well as the changes in immune repertoire.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Hyperthermia for 40 minutes, with maximum temperature setted on 42℃ ± 0.5℃ as upper limit, twice a week for a total of 10 times.
Mononuclear cells were collected from 50ml peripheral blood , and cultured cytokine-induced killer cells for 15-20 days. Cells were infused back to the patients in 3 times via intravenous infusion .Patients will received at least 2 cycles of CIK Immunotherapy . If the evaluation of the treatment is complete response, partial response or stable disease, additional cycles were eligible.
Patients will receive pembrolizumab 100mg every three weeks and assess the clinical outcome every 2 dosage of anti-PD-1 antibody treatment.
Patients will receive standard chemotherapy until disease progression, unacceptable toxicity or patient refusal.
Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital
Beijing, Beijing Municipality, China
Safety (adverse events)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 12 months
Objective response rate (ORR)
Proportion of patients with reduction in tumor burden of a predefined amount
Time frame: 6 months
Progression-free survival of the participants(PFS)
From starting date of the enrollment until the date of first documented disease progression or date of death from any cause, whichever comes first.
Time frame: 12 months
Assessment of Patient- Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
To assess and compare the PRO-CTCAE by patients in each groups
Time frame: 12 months
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