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Randomized controlled study on the reduction of recurrence and metastasis rate of stage ?/? colon cancer after adjuvant chemotherapy with Qushi Kang'ai Recipe (pre-experimental stage)

Randomized controlled study on the reduction of recurrence and metastasis rate of stage ?/? colon cancer after adjuvant chemotherapy with Qushi Kang'ai Recipe (pre-experimental stage)

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055335
Enrollment
Unknown
Registered
2022-01-07
Start date
2022-01-07
Completion date
Unknown
Last updated
2023-01-30

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

Conditions

Colon cancer

Interventions

experimental group:Qushi Kang'ai Granules
control group:Placebo

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Colon cancer patients diagnosed by tissue or cytopathology; 2. Patients who have undergone radical surgery and whose postoperative pathological staging is high-risk stage II/III; 3. Adjuvant chemotherapy has been completed; 4. The last chemotherapy is less than or equal to 3 months from the time of enrollment; 5. PS score (ECOG)<=2 points; 6. Aged 18 to 75 years; 7. Normal liver and kidney function; 8. Sign the informed consent form, the patient is willing to accept the treatment of this program, can insist on taking the medicine, and has good compliance.

Exclusion criteria

Exclusion criteria: 1. Inability to complete the baseline assessment form; 2. Intestinal obstruction or incomplete intestinal obstruction; 3. Combined with other serious diseases, including uncontrolled active infection, severe electrolyte imbalance, bleeding tendency; 4. Pregnant patients and lactating patients; 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 received neoadjuvant radiotherapy before surgery or are planning to receive radiotherapy; 9. Severe brain disease or mental illness that affects the patient's ability to self-report; 10. Have a history of organ transplantation (including bone marrow autologous transplantation and peripheral stem cell transplantation); 11. Those who have no legal capacity, and those who have medical or ethical reasons that affect the continuation of research.

Design outcomes

Primary

MeasureTime frame
Recurrence and metastasis rate;

Secondary

MeasureTime frame
Circulating tumor cell count;Circulating tumor cell DNA;Dampness syndrome scale;

Countries

China

Contacts

Public ContactZhang Haibo
haibozh@gzucm.edu.cn+86 13724123615

Outcome results

None listed

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