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NCT05969847

PHASE2

Organ Preservation Following Enverolimab-based Total Neoadjuvant Therapy for Locally Advanced Very Low Rectal Cancer

Sponsor: 池畔

View on ClinicalTrials.gov

Summary

Patients diagnosed with locally advanced very low rectal cancer were chosen to participate in a comprehensive neoadjuvant therapy (TNT) protocol. This treatment regimen consisted of preoperative fractionated radiotherapy (5×7Gy) combined with 6 cycles of CAPOX chemotherapy and enverolimab. For patients who achieved clinical complete response (cCR) or near-clinical complete response (ncCR) after undergoing TNT, an organ-preserving strategy involving local full-thickness resection was implemented.

Official title: Total Neoadjuvant Therapy With Split-course Hypofraction Radiotherapy Combined With CAPOX and Envafolimab Followed by Local Excision for Locally Advanced Very Low Rectal Cancer: an Open-label, Single-arm, Multi-center, Phase II Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-08-15

Completion Date

2027-12-31

Last Updated

2023-08-01

Healthy Volunteers

Conditions

Rectal Cancer

Interventions

RADIATION

split-course hypofraction radiotherapy

After reaching a cumulative radiotherapy dose of 25Gy in the entire pelvic cavity (PTV1), the treatment field was subsequently narrowed to solely focus on the primary tumor (PTV2), with a total dose of 35Gy administered. All patients will undergo fractionated radiotherapy, following a regimen of 7Gy per fraction, delivered every 3 weeks for five cycles.

DRUG

CAPOX

Drug: Oxaliplatin,130mg/m2，ivgtt，d1,for 6 cycles. Drug: Capecitabine,1000mg/m2，po，bid，d1-14, for 6 cycles.

DRUG

Envafolimab

Envafolimab is administered by subcutaneous injection. The recommended dose is 300 mg per 3 weeks (Q3W) for 6 cycles.

PROCEDURE

Local excision

Local full-thickness resection is employed for patients with clinical complete response (cCR) or near-clinical complete response (ncCR) following TNT.

Inclusion Criteria: 1. Aged 18-75. 2. Histopathology confirmed the rectal adenocarcinoma,cT3-4N0 or cT1-4N1-2. The tumor's lower margin ≤ 2cm from the anorectal ring's upper edge (based on MRI measurement). 3. Eastern tumor cooperation group (ECOG) status:0-2. 4. American Association of Anesthesiologists (ASA) status: I-III. 5. No previous systemic therapy, including chemotherapy, immunotherapy, or radiotherapy for rectal cancer. 6. No previous history of pelvic radiotherapy. 7. Sufficient organ function based on the following parameters: An absolute neutrophil count≥ 1.5 × 109 / L, a thrombocyte count ≥ 100 × 109/ L, a glomerular filtration rate (calculated using the Cockcroft-Gault formula) with a creatinine level ≤ 1.5 × ULN or a creatinine clearance \> 50ml/min, and AST and ALT levels ≤ 2.5 × ULN or a total bilirubin level ≤ 1.5 × ULN. 8. Effective contraception during the study. 9. Patients are willing and able to comply with the protocol during the study period. 10. Patients with written informed consent Exclusion Criteria: 1. Poorly differentiated adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, and adenocarcinoma developed from inflammatory bowel disease. 2. Metastasis to para-aortic, lateral, or inguinal lymph nodes has been identified. 3. Suspected distant metastasis in organs other than para-aortic, lateral, or inguinal lymph nodes is being considered. 4. Known hypersensitivity to platinum drugs or capecitabine. 5. Patients receiving concomitant treatment with drugs that interact with capecitabine or oxaliplatin (such as flucytosine, phenytoin, and warfarin). 6. According to the New York Heart Association (NYHA) classification, III or IV heart failure, and angina pectoris have occurred in the past six months. 7. Uncontrolled active infection or severe concomitant systemic disease. 8. Patients who need immunosuppressive therapy for organ transplantation. 9. Uncontrolled epilepsy or mental illness. 10. Pregnant or lactating female patients. 11. Non-compliance or researchers believe that the patient will not be able to complete the entire trial

Locations (1)

Pan Chi

Fuzhou, Fujian, China