Clinical study of the therapeutic efficacy of Jianpi Tongluo Formula based on microbiome and metabolomic analysis in the treatment of stage III colorectal cancer.

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400085896

Enrollment

Unknown

Registered

2024-06-20

Start date

2023-03-23

Completion date

Unknown

Last updated

2024-07-08

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:Jianpi Tongluo Formula combined with adjuvant chemotherapy for postoperative stage III colorectal cancer. Jianpi Tongluo Formula includes 30g of raw Astragalus membranaceus, 15g of Sop

control group :Refer to the adjuvant chemotherapy guidelines for postoperative colorectal cancer (refer to the 2021 NCCN colon cancer guidelines and the 2021 NCCN rectal cancer guidelines) (1) MFOLFO

·LV 400mg/m2, ivgtt, d1

·5-FU 400mg/m2, iv, d11200mg/(m2 ? d), iv, d2-d3, civ (2400mg/m2, civ46-48h) ·Repeat every 2 weeks

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) Diagnosed as stage III postoperative colorectal cancer according to the above diagnostic criteria; (2) Age = 18 years old, regardless of gender; (3) For patients with an expected survival time of = 6 months, the physical condition scoring standard (ECOG) is = 2; (4) Agree to receive follow-up; (5) Complete follow-up and clinical related medical records; (6) Agree to collect fecal samples before and after medication for microbiological and metabolomic testing; (7) Those who voluntarily sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Merge with other primary malignant tumors; (2) Individuals with severe heart, brain, liver, kidney diseases, electrolyte abnormalities, or mental illness; (3) Individuals who are allergic to the drugs or their components used in this study; (4) Pregnant, lactating, or planned pregnancy patients; (5) Serious or uncontrollable infections exist; (6) Individuals who have taken other traditional Chinese medicine or participated in other clinical trials within the past 2 weeks.

Design outcomes

Primary

Measure	Time frame
Disease-free survival;	—

Secondary

Measure	Time frame
Over survival;QLQ-CR38;Traditional Chinese Medicine Syndrome Points;KPS;CEA CA199 CA50 CA125 AFP;	—

Countries

China

Contacts

Public ContactJianlin Ren

Shanghai Traditional Chinese Medicine Hospital

1057277927@qq.com+86 187 0983 9422

Outcome results

None listed

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