Rectal cancer
Conditions
Interventions
Experimental group:Jianpi Qinghua Formula combined with neoadjuvant therapy
control group:Placebo combined with neoadjuvant therapy
Sponsors
west china hospital of sichuan university
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age 18–75 years; no restrictions on gender. 2.Performance status score of 0–1. 3.Pathologically confirmed rectal adenocarcinoma by colonoscopy, located =15 cm from the anal verge, with distant metastasis excluded by CT, and staged as cT3-4N0-2M0 by rectal MRI, rectal ultrasound, or CT. Immunohistochemistry shows pMMR or genetic testing indicates MSS type, or neoadjuvant therapy is recommended after multidisciplinary team (MDT) discussion. 4.Adequate organ function. 5.Ability to understand the study, with voluntary participation and signed informed consent by the patient and/or legal representative.
Exclusion criteria
Exclusion criteria: 1.Exclusion of Lynch syndrome or dMMR or MSI-H 2.Distant metastasis confirmed during treatment despite initial non-metastatic diagnosis 3.History or concurrent presence of other malignancies (including synchronous colon cancer), except for cured basal cell carcinoma of the skin or cervical carcinoma in situ 4.Pregnant or lactating women 5.Severe underlying diseases, including uncontrolled cardiovascular conditions, diabetes, advanced kidney disease, severe infections, or coagulation disorders 6.History of psychiatric disorders 7.History of gastrointestinal obstruction, fistula, perforation, hemorrhage, or severe ulcers 8.Allergy to components of traditional Chinese medicine or 5-Fu drugs 9.Severe gastrointestinal diseases impairing oral absorption of traditional Chinese medicine or chemotherapy drugs 10.Participation in another clinical trial within 4 weeks prior to treatment initiation 11.Exclusion of patients with underlying systemic immune diseases or ongoing hormone therapy if immunotherapy is to be administered
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic response rate and Clinical complete response rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of complete surgical resection(R0);anal preservation rate;2-year disease-free survival rate (DFS%);toxicity reactions during preoperative neoadjuvant therapy;surgical complications;completion rates of preoperative and postoperative adjuvant therapy;oxicity reactions during postoperative adjuvant therapy;anal function assessment;changes in quality of life; | — |
Countries
china
Contacts
Public ContactMeng Qiu
West china hospital of Sichuan university
Outcome results
None listed