Effect of Qushi Kangai formula for recurrence and metastasis rate in patients with stage II / III colon cancer after adjuvant chemotherapy:A Pilot Trial.

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2200005510

Enrollment

Unknown

Registered

2022-01-07

Start date

2022-01-07

Completion date

Unknown

Last updated

2023-02-20

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

Conditions

Colon cancer

Interventions

control group:Placebo granules,take with water once everyday for six months

experimental group:Qushi Kangai granules,take with water once everyday for six months

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients have been diagnosed with colon cancer by histopathology or cell pathology; (2) Postoperative pathological stage is high-risk stage II / III; (3) Completion of Adjuvant Chemotherapy; (4) The distance from the last chemotherapy to the enrollment time = 3 months; (5) PS score (ECOG) = 2; (6) Age:18 to 75 years old; (7) Normal liver and kidney function; (8) Sign the informed consent form, the patient is willing to accept the treatment of this scheme, can adhere to the medication and has good compliance.

Exclusion criteria

Exclusion criteria: (1) Unable to complete the baseline evaluation form; (2) Intestinal obstruction or incomplete intestinal obstruction; (3) Complicated with other serious diseases, including uncontrolled active infection, serious electrolyte disorder and bleeding tendency; (4) Pregnant and lactating women; (5) Patients with depression, mania, obsessive-compulsive disorder and schizophrenia; (6) Have a history of autoimmune diseases, blood system diseases and organ transplantation, and use hormones or immunosuppressants for a long time; (7) Combined with other uncontrolled tumors; (8) Patients who have been received neoadjuvant radiotherapy before operation or intended to receive radiotherapy; (9) Serious brain disease or mental disease affecting the patient's ability of private prosecution; (10) History of organ transplantation (including bone marrow autotransplantation and peripheral stem cell transplantation); (11) No legal capacity, medical or ethical reasons affect the continuation of the research.

Design outcomes

Primary

Measure	Time frame
Recurrence and metastasis rate;	—

Secondary

Measure	Time frame
Dampness syndrome scale;Circulating tumor DNA(ctDNA);Circulating Tumor Cell(CTC) count;	—

Countries

China

Contacts

Public ContactHai-bo Zhang

haibozh@gzucm.edu.cn13724123615

Outcome results

None listed

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