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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HT+ACT | Experimental |
| |
| HT+ACT+PD-1 | Experimental |
| |
| HT+ACT+CT | Experimental |
| |
| HT+CT | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermotron RF-8 | Device | Hyperthermia for 40 minutes, with maximum temperature setted on 42℃ ± 0.5℃ as upper limit, twice a week for a total of 10 times. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety (adverse events) | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 12 months |
| Objective response rate (ORR) | Proportion of patients with reduction in tumor burden of a predefined amount | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Assessment of Patient- Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital | Beijing | Beijing Municipality | 100038 | China |
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| Adoptive cellular Immunotherapy | Biological | 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. |
|
| Anti-PD-1 antibody | Drug | Patients will receive pembrolizumab 100mg every three weeks and assess the clinical outcome every 2 dosage of anti-PD-1 antibody treatment. |
|
| Chemotherapy | Drug | Patients will receive standard chemotherapy until disease progression, unacceptable toxicity or patient refusal. |
|
To assess and compare the PRO-CTCAE by patients in each groups |
| 12 months |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D010386 | Pelvic Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016219 | Immunotherapy, Adoptive |
| C000711728 | spartalizumab |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
| D007114 | Immunization |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
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