Mid-low Locally Advanced Rectal Cancer (LARC)
Conditions
Interventions
Validation Set:None
Training set:None
Sponsors
Taizhou Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years old; 2. ECOG performance status score of 0-1 at initial treatment; 3. According to the AJCC 8th edition staging system, patients were diagnosed as middle-low LARC. The complete clinical information and corresponding tissue samples of patients with mid-low LARC who received standard treatment were preserved; 5. All tissue samples for expression microarray or mRNA quantitative detection must not have been treated with radiotherapy or chemotherapy; 6. These patients with newly diagnosed middle-low LARC must receive standard treatment: preoperative chemoradiotherapy + radical surgery + adjuvant chemotherapy; 7. All patients had to be followed up based on enhanced MR Imaging by two experienced radiologists with complete follow-up information. 8. Adequate organ and bone marrow functional reserve before treatment, defined as follows: a) complete blood count: absolute neutrophil count (ANC) > 1.5×10^9/L; Absolute lymphocyte count (LC) > =0.5×10^9/L; Platelet count (PLT) > =100×10^9/L; Hemoglobin (Hb) > =9.0 g/dL. b) Liver function: serum total bilirubin (TBIL) = 50mL/min; The results of urine dipstick test showed that urine protein was less than 2+. d) Coagulation function: activated partial thromboplastin time (APTT) and international normalized ratio (INR) 50% within 28 days before treatment; 10. Pulmonary function test was performed within 28 days before treatment, and the percentage of predicted value of forced expiratory volume in one second (PPO-FEV1) and diffusion capacity (PPO-DLCO) was > = 40%. Pulmonary function can be further assessed by quantitative ventilation/perfusion scanning or cardiopulmonary exercise testing if needed, with a maximum oxygen consumption (VO2max) >10mL/kg/min. The tests were repeated during the screening period if clinically indicated.
Exclusion criteria
Exclusion criteria: 1.Presence of synchronous multiple primary tumors; 2.Patients with mental or cognitive impairment who cannot comply with the research plan or follow-up; 3.Pregnant or lactating women; 4.Previous history of gastrointestinal bleeding or perforation; 5.Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 6.Subjects with untreated acute or chronic active hepatitis B (defined as positive Hepatitis B Virus surface antigen [HBsAg] during the screening period and HBV-DNA >=500 IU/mL or above the upper limit of normal at the central laboratory) or hepatitis C (defined as positive Hepatitis C Virus antibody [HCV-Ab] during the screening period with positive HCV-RNA). Subjects undergoing antiviral treatment may be considered for enrollment based on the physician's judgment of the individual case while monitoring viral copy count; 7.Uncontrolled concurrent illnesses, including but not limited to: a) HIV infection (positive HIV antibody). b) Severe infection that is active or poorly controlled clinically. c) Evidence of severe or uncontrolled systemic diseases (e.g., severe psychiatric or neurological disorders, epilepsy or dementia, unstable or decompensated respiratory, cardiovascular, hepatic, or renal diseases, uncontrolled hypertension [defined as hypertension that remains >= CTCAE Grade 2 despite medication]). d) Active bleeding or newly diagnosed thrombotic disease requiring therapeutic anticoagulation, or individuals with a bleeding tendency. e) Active malignancy within the past 5 years, except for locally treated cancers that are considered cured.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Microsatellite Instability (MSI) Status;High recurrence risk characteristics;Clinical TNM Stage (AJCC 8th);RAS/BRAF Mutation Status;Prognostic Gene Signature Score; | — |
Countries
China
Contacts
Public ContactLin Zheng
Taizhou Cancer Hospital
Outcome results
None listed