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Effect and Mechanism of TCM-TSKSR on Advanced Colon Cancer: A Randomized Placebo-Controlled Clinical Trial

Research for synergistic effect with chemotherapy and mechanism of sequential regimen of invigorating spleen and kidney on advanced colon cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022944
Enrollment
Unknown
Registered
2019-05-04
Start date
2019-05-01
Completion date
Unknown
Last updated
2019-05-05

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

Conditions

Advanced Colon Cancer

Interventions

Sponsors

Xiyuan Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Patient with pathological diagnosis of colon cancer,tumor-node-metastasis(TNM)Stage IV colon cancer according to 8th edition of American Joint Committee on Cancer(AJCC)Staging Manual; (2) Receiving or plan to start chemotherapy of XELOX or XELIRI; (3) Aged between 18 to 80 years male and female and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. History of previous malignancy other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin. 2. serious heart,liver or kidney dysfunction. 3. Those who cannot take the study drug orally because of bowel obstruction and/or require for peripheral vein nutrition;or malabsorption or diseases that affect the absorption;or active peptic ulcer disease. 4. Any unstable conditions or conditions that may endanger the safety of patients and their compliance with the study; 5. Patients who received any of the following treatments during a specified period prior to the research: (1) received antibiotic treatment within 2 weeks; (2) receiving intestinal flora regulator.

Design outcomes

Primary

MeasureTime frame
MD Anderson Symptom Inventory (MDASI) Score;DCR;

Secondary

MeasureTime frame
Edmonton Symptom Assessment Scale(ESAS) score;Change of Spleen Deficiency Scale Score;Change of Kidney Deficiency Scale Score;Incidence of adverse effects(AEs);

Countries

China

Contacts

Public ContactYun Xu

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Xyxiao78@163.com+86 15210775378

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026