Rectal Artery Infusion Chemotherapy Combined With Anti-PD1 Antibody for MSS LARC

• Status: Not yet recruiting
• Trial end date: 2025-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to explore whether rectal artery infusion chemotherapy combined with anti-PD1 antibody is an effective neoadjuvant therapy for the microsatellite stable locally advanced rectal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Treatments: Antibodies; Antibodies, Monoclonal; Capecitabine; Oxaliplatin

Criteria

Inclusion Criteria:

1. Pathologically diagnosed rectal adenocarcinoma; 2. Age ≥18 years old and ≤75 years old; 3. MRI stage T3/4 and or N+, and no distant metastasis; 4. Life expectancy of 1 year The above; 5. Informed consent, no contraindications to chemotherapy exist; 6. The distance from the lower edge of the tumor to the anus is less than or equal to 12cm by MRI;

Exclusion Criteria:

1. Refused to participate in this study; 2. Multifocal colorectal cancer; 3. Past history of malignant tumors, except for basal cell carcinoma/papillary thyroid carcinoma/various types of carcinoma in situ; 4. Unable to receive chemotherapy , such as but not limited to bone marrow suppression, etc; etc.); 5. Major organ diseases (such as but not limited to COPD, coronary heart disease and renal insufficiency, etc.) acute attack and or severe acute infectious diseases (such as but not limited to hepatitis, pneumonia and myocarditis, etc.), ASA score> 3; 6. Mental disorder or illiteracy or language and communication barriers cannot understand the research plan;

7. There are contraindications to arterial puncture, such as but not limited to severe arteriosclerosis or even atresia, coagulation dysfunction, long-term use of anticoagulant drugs and cannot be stopped, etc.; 8. Rectal tumor has obstruction or high risk of obstruction and or there is bleeding and/or perforation; 9. Peripheral sensory nerve disorder, unable to receive oxaliplatin chemotherapy; 10. Lateral pelvic lymph node metastasis (mainly supplied by internal iliac artery); 11 , pregnancy or breastfeeding; 12. Unable to accept MRI examination; 13. Consecutive use of glucocorticoids for more than 3 days within 1 month before signing the consent form;

14. Tumor directly invades or adheres to adjacent organs、structures(T4b) or tumor invaded MRF（Mesoretal Fascia）;15.Other scenarios deemed inappropriate by the investigators.