Combination of Cancer Ablation and Life Information Rehabilitation Therapy for Unresectable Lung Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Relief degree of tumors
Study Overview
Brief Summary
The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable lung cancer.
Detailed Description
By enrolling patients with unresectable lung cancer adapted to enrolled criteria, this study will document for the first time the synergistic effect of cancer ablation and life information rehabilitation therapy. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies
- •Body tumor 1-6, with at least one tumor length > 2 cm
- •KPS ≥ 70, lifespan > 6 months
- •Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L
Exclusion Criteria
- •Patients with cardiac pacemaker
- •Patients with brain metastasis
- •Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Arms & Interventions
Cancer ablation
In this group, the patients will receive ablation therapy (e.g. cryosurgery or irreversible electroporation) first for big tumors (> 2 cm). The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
Intervention: Cancer ablation (Device)
Life information rehabilitation therapy
In this group, the patients will drink "Qilisheng" Immunoregulatory Oral Solution for consecutive 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
Intervention: Life information rehabilitation therapy (Drug)
Combination therapy
In this group, the patients will receive the combination therapy including ablation and life information rehabilitation therapy. The ablation therapy (e.g. cryosurgery or irreversible electroporation) will be performed first for big tumors (> 2 cm), then "Qilisheng" Immunoregulatory Oral Solution will be provided for consecutive 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
Intervention: Cancer ablation (Device)
Combination therapy
In this group, the patients will receive the combination therapy including ablation and life information rehabilitation therapy. The ablation therapy (e.g. cryosurgery or irreversible electroporation) will be performed first for big tumors (> 2 cm), then "Qilisheng" Immunoregulatory Oral Solution will be provided for consecutive 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
Intervention: Life information rehabilitation therapy (Drug)
Outcomes
Primary Outcomes
Relief degree of tumors
Time Frame: 3 months
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
Secondary Outcomes
- Progress free survival（PFS）(1 year)
- Overall survival（OS）(3 years)