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Double-blinded Randomized Controlled Trial for Qu-Xie Capsule Regulating Gut Micro-biome and Body Immune System in Patients with Advanced Colorectal Cancer

Study on Mechanism of TCM 'Strengthening the Body Resistance to Eliminate Pathogenic Factors' Theory's Effectiveness on Advanced Colorectal Cancer Based on Toll-like Receptors Controlling Gut Microbiome and Host Immune Balancing

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029599
Enrollment
Unknown
Registered
2020-02-05
Start date
2018-04-01
Completion date
Unknown
Last updated
2020-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer

Interventions

Sponsors

Xiyuan Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Colorectal cancer patients with definite pathological diagnosis; 2. The stage of TNM was diagnosed as stage IV by imaging or pathology, and the metastasis could not be resected; 3. Aged 18-80 years old, gender unlimited; 4. Chemotherapy, pelvic radiotherapy, targeted therapy and immunotherapy have been completed for at least 1 month; 5. The estimated survival time is more than half a year or more; 6. Patients with informed consent and good compliance.

Exclusion criteria

Exclusion criteria: 1. Previous or combined history of other primary malignant tumors; 2. Severe cardiovascular complications, severe liver and kidney dysfunction; 3. The patients with intestinal obstruction can't be treated by oral medicine and need intravenous high energy nutrition 4. Severe malabsorption or other diseases affecting gastrointestinal absorption; 5. Subjects who received any of the following treatments during a specific period prior to enrollment: (1) The patients were treated with antibiotics orally or intravenously within 2 weeks; (2) Receiving intestinal flora regulator (such as Peifeikang, Lactobacillus tablet, etc.).

Design outcomes

Primary

MeasureTime frame
OS;

Secondary

MeasureTime frame
ESAS;TCM syndrome scale;Gut microbiome;

Countries

China

Contacts

Public ContactYufei Yang

Xiyuan Hospital of China Academy of Chinese Medical Sciences

yyf93@vip.sina.com+86 13701366913

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026