Concurrent Use of JianPi-Bushen Formula during Adjuvant Chemotherapy among Colorectal Cancer Patients Enhancing Disease Free Survival Outcome(PIONEER): A Phase III Randomized, Doubled Blinded, Placebo Controlled Clinical Trial

Evidence-based evaluation and translational application research on adjuvant chemotherapy combined with JianPi-Bushen Formula for colorectal cancer to reduce toxicity and enhance long-term efficacy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2025001810

Enrollment

Unknown

Registered

2025-09-24

Start date

2025-10-09

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

Colorectal Cancer

Interventions

Experimental group:JianPi-Bushen Formula

Control group:Placebo

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1)Patients who have a pathological diagnosis of high-risk stage II, III, and IV colorectal cancer (simultaneously resectable); (2)Patients who have completed radical surgical resection(within 6 weeks after surgery), and is about to start adjuvant chemotherapy (FOLOFOX, CAPOX, or single-agent capecitabine chemotherapy) ; (3)Age range: 18-80 years old, gender is not limited; (4)The type of TCM syndrome is not limited; (5)Signed informed consent.

Exclusion criteria

Exclusion criteria: (1)Patients who take other traditional Chinese medicine based on syndrome differentiation orally during chemotherapy; (2)Patients who have received neo-adjuvant radiation and chemotherapy before surgery; (3)Patients who have occurred intestinal obstruction and cannot take herbal medicine, requiring intravenous high-energy nutrition; Patients who suffer from malabsorption syndrome or other diseases that affect gastrointestinal absorption; (4)Patients who have any unstable situation or situation that may endanger patient safety and their compliance with the study; (5)Patients who have history of previous or combined other malignant tumors; (6)Patients who participated in other clinical trials within one month or is still in other clinical trial and has not finished yet.

Design outcomes

Primary

Measure	Time frame
Disease Free Survival Rate of 1-3 years after colorectal cancer radical surgery;	—

Secondary

Measure	Time frame
Chemotherapy induced side-effects;Chemotherapy completion rate and chemotherapy compliance;Quality of life and rehabilitation needs and their satisfaction during survivorship;Imaging diagnosis report, tumor markers, circulating tumor DNA;	—

Countries

China

Contacts

Public ContactLingyun Sun

Xiyuan Hospital, China Academy of Chinese Medical Sciences

slyslysun@126.com13810814863

Outcome results

None listed

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