Combination of Immunotherapy and Hyperthermia in Advanced Malignant Mesothelioma
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|ClinicalTrials.gov Identifier: NCT03393858|
Recruitment Status : Recruiting
First Posted : January 9, 2018
Last Update Posted : July 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cancer Mesothelioma, Malignant||Drug: Anti-PD-1 antibody Biological: DC-CIK Immunotherapy Device: Thermotron RF-8EX||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Study of Combination of Anti-PD-1 Plus Autologous DC-CIK Cell Immunotherapy and Hyperthermia for Patients With Advanced Malignant Mesothelioma|
|Actual Study Start Date :||December 1, 2017|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||June 30, 2022|
|Experimental: Immunotherapy plus Hyperthermia||
Drug: Anti-PD-1 antibody
Patients will receive pembrolizumab 100mg every three weeks until disease progression, unacceptable toxicity or patient refusal.
Biological: DC-CIK Immunotherapy
Mononuclear cells were collected from 50ml peripheral blood , and cultured DC-CIK 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 DC-CIK Immunotherapy along with 4 dosage of anti-PD-1 antibody treatment. If the evaluation of the treatment is partial response or stable disease, additional cycles were eligible.
Device: Thermotron RF-8EX
Hyperthermia for 40 minutes, with maximum temperature setted on 42℃ ± 0.5℃ as upper limit, twice a week since the 1st week of pembrolizumab for a total of 10 times.
- Progression-free survival of the participants(PFS) [ Time Frame: 24 months ]From starting date of anti-PD-1 antibody treatment until date of until the date of first documented disease progression or date of death from any cause, whichever comes first.
- 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.
- Assessment of Patient- Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [ Time Frame: 24 months ]To assess and compare the PRO-CTCAE by patients receiving immunotherapy
- Safety (adverse events) [ Time Frame: 24 months ]Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393858
|Contact: Jun Ren, MD,PhDfirstname.lastname@example.org|
|Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital||Recruiting|
|Beijing, China, 100038|
|Contact: Jun Ren, MD, PhD 86-10-63926317 email@example.com|