Rectal cancer
Conditions
Interventions
Experimental Group:Neoadjuvant chemoradiotherapy combined with Qinghua-Lizhong Formula
Control Group:Neoadjuvant chemoradiotherapy combined with placebo
Sponsors
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Histologically confirmed rectal adenocarcinoma; the lower margin of the tumor is = 12 cm from the anal verge (by endoscopy) or = 8 cm from the anorectal junction (ARJ); initial local staging by MRI is T3-4 or lymph node-positive; no evidence of distant metastasis; initially evaluated as resectable rectal cancer; clinical imaging stage II-III; (2) Patients planned to receive neoadjuvant chemoradiotherapy; (3) Aged 18 to 80 years, male or female; (4) Karnofsky Performance Status (KPS) score = 70; (5) Meet the criteria for chemoradiotherapy, without severe organ dysfunction (Routine blood test: ANC > 1,500 cells/mm³, HGB > 9.0 g/dL, PLT > 100,000/mm³; Blood biochemistry: total bilirubin = 1.5 × ULN, AST = 2.5 × ULN, ALT = 2.5 × ULN; serum creatinine = 1.5 × ULN and endogenous creatinine clearance = 50 mL/min [Cockcroft-Gault formula]; patients with well-controlled hypertension are eligible; International Normalized Ratio [INR] and activated partial thromboplastin time [aPTT] = 1.5 × ULN [only applicable to patients not receiving anticoagulant therapy; patients receiving anticoagulant therapy should have anticoagulants maintained within the required therapeutic range]; normal cardiac function, i.e., normal electrocardiogram [ECG] or abnormal ECG without clinical significance, and left ventricular ejection fraction [LVEF] > 50% by echocardiography); (6) The patient has read and signed the informed consent form for this study, and agreed to participate in this study.
Exclusion criteria
Exclusion criteria: (1) Recurrent rectal cancer; (2) History of other malignancies within the past 5 years (excluding cured basal cell carcinoma and squamous cell carcinoma of the skin); (3) Currently receiving other investigational anti-tumor therapies; (4) Deficient mismatch repair (dMMR) / microsatellite instability-high (MSI-H) patients who are expected to potentially receive immunotherapy; (5) Patients with intestinal obstruction who are unable to take oral traditional Chinese medicine; (6) Concurrent severe cardiovascular complications, cerebrovascular complications, active hepatitis, or severe hepatic or renal dysfunction; (7) Prior history of surgery or chemotherapy for rectal cancer, or prior history of pelvic radiotherapy; (8) Known or suspected allergy to any known components of the study medications; (9) Pregnant or lactating women; (10) Patients deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response rate;MRI downstaging rate;Quality of life assessment;3-year Event-Free Survival rate;3-year Local Recurrence-Free Survival rate;Absolute lymphocyte count at the end of chemoradiotherapy;3-year Overall Survival rate;Sustained clinical Complete Response rate; | — |
Countries
China
Contacts
Public ContactYun Xu
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Outcome results
None listed