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Cohort of integrated traditional Chinese and western medicine nutritional support for neoadjuvant treatment of rectal cancer

Cohort of integrated traditional Chinese and western medicine nutritional support for neoadjuvant treatment of rectal cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075127
Enrollment
Unknown
Registered
2023-08-25
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-08-28

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

Conditions

Rectal Cancer

Interventions

Control group (Standard nutritional support):NA
Interventional group (Traditional Chinese medicine+standard nutrition support):NA

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Age = 18 years old. (2) Pathological diagnosis was rectal adenocarcinoma. (3) Local advanced stage (T3-T4 or N+) was diagnosed by CT, MRI and/or endoscopic ultrasonography. (4) Subjects must have good organ functions and be evaluated according to the following laboratory examination results: Absolute neutrophil count (ANC) of blood system = 1.5 × 10~9/L Platelet = 70 × 10~9/L Hemoglobin = 90 g/L or = 5.6 mmol/L Renal serum creatinine = 1.5 × ULN or serum creatinine clearance = 40 mL/min Total bilirubin of liver = 1.5 × ULN AST= 2.5 × ULN ALT= 2.5 × ULN International normalized coagulation ratio (INR) = 1.5 × ULN Prothrombin time (PT) = 1.5 × ULN (5) Men with fertility and women of childbearing age must agree to take effective contraceptive measures within 180 days from the signing of the informed consent to the end of concurrent radiotherapy and chemotherapy. Women of childbearing age include premenopausal women and women within 2 years after menopause. Pregnancy must be excluded for women of childbearing age before concurrent radiotherapy and chemotherapy.

Exclusion criteria

Exclusion criteria: (1) Patients with severe bleeding tendency and severe infection. (2) Patients who cannot cooperate with continuous follow-up. (3) Other primary malignant tumors occurred within 5 years before concurrent radiotherapy and chemotherapy, except for locally curable malignant tumors after radical treatment (such as basal or squamous cell skin cancer, superficial bladder cancer or prostate, cervical or breast cancer in situ). (4) Have uncontrollable concomitant diseases, including but not limited to symptomatic congestive heart failure, uncontrollable hypertension, unstable angina pectoris, arrhythmia, active peptic ulcer or hemorrhagic disease. (5) Patients with a history of alcohol or drug abuse.

Design outcomes

Primary

MeasureTime frame
Tumor Degradation Rate;

Secondary

MeasureTime frame
Overall Survival;Cancer Specific Survival;Disease-free Suvival;

Countries

China

Contacts

Public ContactHao Wang

Peking University Third Hospital

hhbysy@126.com+86 186 1120 7267

Outcome results

None listed

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