Status:
UNKNOWN
Neoadjuvant Arterial Embolization Chemotherapy Combined PD-1 Inhibitor for Locally Advanced Rectal Cancer
Lead Sponsor:
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Collaborating Sponsors:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Rectal Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Rectal cancer is one of the common malignant tumors of the digestive tract. Some patients with rectal cancer are already advanced tumors when they are first diagnosed. At this time, the tumor has loca...
Eligibility Criteria
Inclusion
- Pathologically confirmed rectal adenocarcinoma (immunohistochemistry, polymerase chain reaction(PCR) or next-generation sequencing(NGS) sequencing methods are acceptable).
- Magnetic resonance imaging (MRI) measurement of tumor inferior margin ≤12cm from the anus.
- MRI staging is cT3-4 N0 or cT1-4 N+, no multiple primary cancers or distant metastasis.
- Life expectancy ≥ 1 year.
- No anti-tumor therapy, no contraindications to interventional embolization, immunotherapy and chemotherapy.
- Patients who understand the study protocol and are willing to participate in this study provide written informed consent.
Exclusion
- Refuse to participate in this study.
- Multifocal colorectal cancer.
- Past history of malignancy, excluding basal cell carcinoma/papillary thyroid carcinoma/various types of carcinoma in situ.
- Inability to receive chemotherapy, such as but not limited to bone marrow suppression, etc.
- Major organ diseases (such as but not limited to chronic obstructive pulmonary disease, coronary heart disease and renal insufficiency, etc.) during acute exacerbation and or severe acute infectious diseases (such as but not limited to hepatitis, pneumonia and myocarditis, etc.), American Society of Anesthesiologists(ASA) score \> 3.
- Mental disability or illiteracy or language and communication barriers cannot understand the research protocol.
- There are contraindications to arterial puncture, such as but not limited to severe arteriosclerosis or even atresia, coagulation dysfunction, long-term use of anticoagulants and cannot be stopped, etc.
- Obstruction or high risk of obstruction by rectal tumor and/or bleeding and/or perforation.
- Peripheral sensory nerve disorder, unable to receive oxaliplatin-based chemotherapy.
- Lateral pelvic lymph node metastasis (mainly supplied by the internal iliac artery).
- Pregnancy or breastfeeding.
- Contraindications for MRI。
- Consecutive use of corticosteroids for more than 3 days within 1 month before signing the consent form。
- MRI assessment was T4b or MRF positive。
- Other scenarios deemed inappropriate by the investigators for this study.
Key Trial Info
Start Date :
November 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2025
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT05420584
Start Date
November 29 2022
End Date
October 31 2025
Last Update
May 11 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, China, 322000