Bioinformation Therapy for Intestinal Cancer

NCT03350490 | Completed Phase 2

• 1 other identifier: Bioinformation-intestinal
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Intestinal Cancer

Keywords

Cancer ablation; Life information rehabilitation therapy

Outcome Measures

Primary Outcomes (1)

• Relief degree of tumors

  It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）

  3 months

Secondary Outcomes (2)

• Progress free survival（PFS）

  1 year

• Overall survival（OS）

  3 years

Study Arms (4)

Cancer ablation

ACTIVE COMPARATOR

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).

Device: Cancer ablation

Life information rehabilitation therapy

ACTIVE COMPARATOR

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).

Drug: Life information rehabilitation therapy

Combination therapy

EXPERIMENTAL

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).

Device: Cancer ablation; Drug: Life information rehabilitation therapy

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).

Interventions

Cancer ablation DEVICE

Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound.

Also known as: Cryoablation or irreversible electroporation

Cancer ablation; Combination therapy

Life information rehabilitation therapy DRUG

Each treatment: one bottle solution each day, consecutive 3 months, oral administration

Also known as: "Qilisheng" Immunoregulatory Oral Solution

Combination therapy; Life information rehabilitation therapy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with cardiac pacemaker
• Patients with brain metastasis
• Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Sponsors & Collaborators

• Fuda Cancer Hospital, Guangzhou: lead
• Shengxin Biotechnology Institute, Beijing: collaborator

Study Sites (1)

Fuda cancer institute of Fuda cancer hospital

Guangzhou, Guangdong, 510665, China

Location

MeSH Terms

Interventions

Cryosurgery; Electroporation

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2017
• First Posted: November 22, 2017
• Study Start: November 30, 2017
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: January 25, 2019

Record last verified: 2017-11

Locations

CN (1)