A Series of Studies on the Organ Preservation Therapeutic Model for Rectal Cancer Based on Neoadjuvant Therapy- Constructing a Predictive Model for cCR After Neoadjuvant Therapy in Rectal Cancer Based on Radiomics, Microbiomics, and Circulating Tumor DNA

Phase 1

• Conditions: Rectal cancer

• Registration Number: ChiCTR2400089045
• Lead Sponsor: Beijing Cancer Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age: =18 years old, gender unrestricted.<br>2. ECOG (Eastern Cooperative Oncology Group) performance status: 0-1.<br>3. Pathological diagnostic criteria: diagnosed as rectal adenocarcinoma through histopathological and/or cytological examination.<br>4. Clinical diagnostic criteria: baseline rectal MRI confirms clinical staging as T3-T4 or any T stage with N+ (8th edition AJCC staging system) and baseline examination indicates no distant metastasis.<br>5. Digital rectal examination or colonoscopy confirms that the lower margin of the tumor is =15 cm from the anal verge.<br>6. No other severe medical comorbidities.<br>7. Conscious, able to cooperate with positioning, setup, and treatment.<br>8. The subject voluntarily joins this study, signs the informed consent form, has good compliance, and is willing to accept follow-up.<br>9. Plans to undergo radical rectal cancer surgery in this hospital.<br>10. No history of pelvic radiotherapy.<br>11. Important organs or functions meet the following requirements (use of any blood components or growth factors to correct results within 2 weeks before examination is not allowed): able to control bowel and urinary functions autonomously to facilitate radiotherapy preparation; absolute neutrophil count (ANC) =1.5×10?/L, platelets =100×10?/L, hemoglobin =10g/dL; serum albumin =3.0 g/dL, total bilirubin =ULN (upper limit of normal), ALT, AST, and/or ALP =2.5 ×ULN, serum creatinine =ULN; international normalized ratio (INR) and activated partial thromboplastin time (APTT) =ULN.<br>12. Women of childbearing potential must have a negative serum HCG test result within 7 days prior to enrollment and voluntarily use appropriate contraception during the observation period and for 8 weeks after the last administration of chemoradiotherapy; for men, they must have undergone surgical sterilization or agree to use appropriate contraception during the observation period and for 8 weeks after the last administration of chemoradiotherapy.

Exclusion Criteria

1. ECOG = 2, or KPS score = 70;<br>2) Age > 75 years old;<br>3) Distant metastasis;<br>4) Previous or concurrent malignancy, excluding adequately treated basal cell carcinoma of the skin, early-stage thyroid cancer, breast cancer with excellent prognosis, etc.;<br>5) Known allergy to capecitabine;<br>6) Recurrent rectal cancer;<br>7) Uncontrolled medical conditions: current active infection (NCI-CTCAE grade > 2); clinically significant cardiac disease; New York Heart Association (NYHA) = class II congestive heart failure; unstable symptomatic arrhythmias or peripheral vascular disease = grade II; myocardial infarction or cerebrovascular accident within 6 months prior to enrollment;<br>8) Need for emergency surgery due to intestinal obstruction, perforation, bleeding, etc.;<br>9) Gastrointestinal disorders causing impaired capecitabine absorption, such as short bowel syndrome, inflammatory bowel disease, etc.;<br>10) Concomitant unresectable intestinal disease;<br>11) Predicted survival of less than 3 months;<br>12) Contraindications or relative contraindications to MRI examination, including allergy to MRI contrast agents;<br>13) Lactating, pregnant, or fertile women without adequate contraception;<br>14) Psychiatric or medical conditions rendering the patient unable to give informed consent;<br>15) Poor compliance or deemed unsuitable for the clinical trial by the investigator;<br>16) Received anti-tumor treatment prior to screening;<br>17) History of immune deficiency, including HIV positive status, other acquired or congenital immunodeficiency diseases, organ transplantation, or allogeneic bone marrow transplantation;<br>18) Active hepatitis B (HbsAg positive, and HBV-DNA = 2500 copies/ml or 500 IU/ml) or hepatitis C (anti-HCV positive, and HCV-RNA above the detection limit of the assay); co-infection with hepatitis B and hepatitis C (HbsAg or HbcAb positive and HCV antibody positive).

Study & Design

• Study Type: Diagnostic test
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
complete response;

Secondary Outcome Measures

Name	Time	Method
Sensitivity, SE;Specificity, SP;Positive predicative value;negative predictive value;Accuracy;