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Randomised controlled clinical observation and mechanism study of KangYanJingFang combined with chemotherapy in the treatment of stage II high-risk - stage III colorectal cancer after radical surgery

Randomised controlled clinical observation and mechanism study of KangYanJingFang combined with chemotherapy in the treatment of stage II high-risk - stage III colorectal cancer after radical surgery

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087511
Enrollment
Unknown
Registered
2024-07-29
Start date
2024-04-05
Completion date
Unknown
Last updated
2024-08-05

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

Conditions

colorectal cancer

Interventions

Treatment group:CapeOx or FOLFOX + KangYanJingFang for Stage II High Risk - Stage III postoperative patients with colorectal cancer, 6 months observation. Composition of KangYanJingFang: 15g of Radix
Control group:Stage II high-risk postoperative patients with stage III colorectal cancer treated with CapeOx or FOLFOX chemotherapy regimens for six months

Sponsors

Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) After radical surgery for colorectal cancer; (2) Age between 18 and 75 years old; (3) Western medical diagnosis in accordance with the American Joint Committee on Cancer (AJCC)/International Union Against Cancer (UICC) staging, with TNM staging of stage II high-risk-stage III requiring chemotherapeutic treatment; (4) Expected survival of more than 6 months (5) Subjects with normal cognitive function and no dysfunction of major organs. (6) Agree to comply with the study protocol, sign the informed consent form, and complete the study according to the protocol requirements.

Exclusion criteria

Exclusion criteria: (1) Those with a combined history of other malignancies; (2) Those with severe or uncontrolled medical disorders and infections; (3) Are participating in other clinical studies or have participated in other clinical studies within 1 month; (4) Allergic patients; (5) Pregnant and lactating women; (6) Those with a history of psychiatric disorders that cannot be easily controlled; (7) Patients receiving radiotherapy treatment.

Design outcomes

Primary

MeasureTime frame
Chemotherapy completion rate;Chinese Medicine Score;Cancer Fatigue Scale;

Secondary

MeasureTime frame
Karnofsky Performance Status;

Countries

China

Contacts

Public ContactZhenye Xu

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

xuzhenye1947@126.com+86 159 2134 1313

Outcome results

None listed

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