Clinical Trial: Combination with dendritic cell vaccine therapy and cryoablation for lung cancers (Japan)

Tokyo, Nov. 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059855) titled 'Combination with dendritic cell vaccine therapy and cryoablation for lung cancers' on Nov. 22.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Historical

Primary Sponsor: Institute - Kashiwa Kousei General Hospital

Condition: Condition - Malignant pulmonary tumor Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - For malignant lung tumors with multiple metastases, combination with cryoablation for the largest lung tumors and dendritic cell vaccine therapy is examined for additive or synergy effect for the metastases. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Treatment period is 3 months. Dendritic cells are extracted from the patient, which are incubated with cancer antigen or cytokine to strengthen the immunity. Every 2-3 weeks, dendritic cells are injected subcutaneously at the Precision Clinic, which is approved from the Ministry of Welfare. The day after the 1st administration of dendritic cells, the cryoablation is conducted for the largest pulmonary tumor. After the cryoablation, the dendritic cells are injected subcutaneously every 2-3 times for 6 times.

Eligibility: Age-lower limit - 15 years-old = Gender - Male and Female Key inclusion criteria - The patient has multiple metastases, of which one exists in lung and its size is over 2 cm. The patient has been already treated by chemotherapy, of which effect is stable or progressive disease. The patient performance status is lower than 2. Key exclusion criteria - Myelodysplastic syndromes. Severe clinical symptoms. Psychiatric disorders. Immunocompromised disease. Pregnant or breast-feeding woman. Unsuitable status judged by doctor in charge. Target Size - 100

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 11 Month 22 Day Date of IRB - 2025 Year 11 Month 12 Day Anticipated trial start date - 2025 Year 11 Month 22 Day Last follow-up date - 2035 Year 11 Month 22 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068406

Disclaimer: Curated by HT Syndication.