Bioinformation Therapy for Intestinal Cancer

Fuda Cancer Hospital, Guangzhou

Status and phase: Completed; Phase 3; Phase 2

Conditions: Advanced Intestinal Cancer

Treatments: Device: Cancer ablation; Drug: Life information rehabilitation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03350490

Bioinformation-intestinal

Details and patient eligibility

About

The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable intestinal cancer.

Full description

By enrolling patients with unresectable intestinal 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).

Enrollment: 120 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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 ：3 - 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 4 patient groups

Cancer ablation

Active Comparator group

Description:

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).

Treatment:

Device: Cancer ablation

Life information rehabilitation therapy

Active Comparator group

Description:

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).

Treatment:

Drug: Life information rehabilitation therapy

Combination therapy

Experimental group

Description:

In this group,the patients will receive combination therapy,including ablation and life information rehabilitation therapy.They will receive ablation therapy(e.g. cryosurgery or irreversible electroporation)first for big tumors(\>2cm),then 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).

Treatment:

Drug: Life information rehabilitation therapy

Device: Cancer ablation

Control

No Intervention group

Description:

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).