Status:
UNKNOWN
Rectal Artery Infusion Chemotherapy Combined With Anti-PD1 Antibody for MSS LARC
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Rectal Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 r...
Detailed Description
Neoadjuvant chemoradiation is the standard treatment for locally advanced rectal cancer. Neoadjuvant chemoradiotherapy can achieve a pathological complete response rate (pCR) of about 20%. However, ra...
Eligibility Criteria
Inclusion
- Pathologically diagnosed rectal adenocarcinoma
- Age ≥18 years old and ≤75 years old
- MRI stage T3-4aNany and TanyN1-2, but not T4b and no distant metastasis
- Life expectancy of 1 year The above
- Informed consent, no contraindications to chemotherapy exist
- The distance from the lower edge of the tumor to the anus is between 5cm to 12cm by MRI
Exclusion
- Refused to participate in this study
- Multifocal colorectal cancer
- Past history of malignant tumors, except for basal cell carcinoma/papillary thyroid carcinoma/various types of carcinoma in situ
- Unable to receive chemotherapy , such as but not limited to bone marrow suppression, etc
- 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
- Mental disorder or illiteracy or language and communication barriers cannot understand the research plan
- 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
- Rectal tumor has obstruction or high risk of obstruction and or there is bleeding and/or perforation
- Peripheral sensory nerve disorder, unable to receive oxaliplatin chemotherapy
- Lateral pelvic lymph node metastasis (mainly supplied by internal iliac artery)
- Pregnancy or breastfeeding
- Unable to accept MRI examination
- Consecutive use of glucocorticoids for more than 3 days within 1 month before signing the consent form
- Tumor directly invades or adheres to adjacent organs、structures(T4b) or tumor invaded MRF（Mesoretal Fascia）
- Other scenarios deemed inappropriate by the investigators
Key Trial Info
Start Date :
May 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 25 2025
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT05307198
Start Date
May 11 2022
End Date
April 25 2025
Last Update
October 10 2023
Active Locations (1)
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1
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000