Combination of Cancer Ablation and Life Information Rehabilitation Therapy for Unresectable Pancreatic Cancer
| Registry | NCT03239184 |
|---|---|
| Status | Completed |
| Phase | Phase 2 / Phase 3 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 120 (Actual) |
| Sponsor | Fuda Cancer Hospital, Guangzhou (Other); collaborators: Shengxin Biotechnology Institute, Beijing |
| Conditions | Unresectable Pancreatic Cancer |
| Interventions | Cancer ablation, Life information rehabilitation therapy (Device, drug) |
| Dates | start 2017-09-01, primary completion 2018-09-01, completion 2018-09-01, first posted 2017-08-03, last updated 2019-01-25 |
| Locations | 1 site in China |
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The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable pancreatic cancer.
By enrolling patients with unresectable pancreatic 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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Cancer ablation | Active comparator | Device: 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). |
| Life information rehabilitation therapy | Active comparator | Drug: 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). |
| Combination therapy | Experimental | Device: Cancer ablation; Drug: Life information rehabilitation 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). |
| Control | No intervention | In this group, the patients will receive no special treatment and as a control group. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). |
Sex: All, ages: 30 Years to 70 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Fuda cancer institute of Fuda cancer hospital | Guangzhou, Guangdong | China |