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Inject carbon nanoparticle as a lymph node tracer before the patient receive neoadjuvant therapy.

Do not inject carbon nanoparticle during the treatment.

Injection carbon nanoparticle via rectal mucosa before neoadjuvant therapy

Injection CNP before NAT

Yingjiang Ye, MD,PhD

Zhidong Gao, MD

The purpose of this study is to evaluate whether injection of carbon nanoparticle as a lymph node tracer before neoadjuvant radiochemotherapy in rectal cancer can increase lymph node yield after surgery compared which do not inject.

This is the randomized controlled, multi-centers，and open-labeled study. The lymph node yield was significantly decreased in rectal cancer after neoadjuvant radiochemotherapy (NAT), hard for pathologists to detect, and is difficult to meet the guideline that minimun of 12 lymph nodes should be retrived after surgery in colorectal cancer. Carbon nanoparticle (CNP) is a specific lymph node tracer, which only dyeing the lymph node, and can keep the lymph node in dyeing state in at least half year. The inverstigator attempted to compare the amount of lymph node yield after surgery in locally advanced rectal caner between injection CNP before NAT and no injection CNP before NAT. In this study, the participants with clinical TNM stage T3+ or N+ will be recruited. The participants will be randomized (1:1 ratio) to a control and intervention arm. The participants in the control arm will not receive injection of any kind lymph node tracers. The participants in the intervention arm will receive injection of CNP before NAT. And the specimen would be evaluated by the pathologist.

Carbon Nanoparticles as Lymph Node Tracer in Rectal Cancer After Neoadjuvant Radiochemotherapy

Prospective Randomized Clinical Trial of Carbon Nanoparticles as Lymph Node Tracer in Rectal Cancer After Neoadjuvant Radiochemotherapy

We need to discuss with other centers, then decide whether to share IPD

Amount of lymph node yield, dyeing lymph node, positive lymph node and the dyeing positive lymph node

Quality of surgery determined using the mesorectal grading system

Surgical morbidity reported according to Clavien-Dindo classification

Overall Survival is defined as the time from the date of surgery to the date of death

Disease Free Survival is defined as the time from the date of surgery to the date of the local recurrence, and/or distant disease, or tumor-related death

Local recurrence rate is defined as the time from the date of surgery to the date of the local recurrence

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Carbon Nanoparticles as Lymph Node Tracer in Rectal Cancer After Neoadjuvant Radiochemotherapy	NCT03550001	Rectal Cancer	Injection CNP b...	18 Years - 75 Years	Peking University People's Hospital
Carbon Nanoparticles as Lymph Node Tracer in Rectal Cancer After Neoadjuvant Radiochemotherapy	NCT03550001	Rectal Cancer	Injection CNP b...	18 Years - 75 Years	Peking University People's Hospital
Carbon Nanoparticles as Lymph Node Tracer in Rectal Cancer After Neoadjuvant Radiochemotherapy	NCT03550001	Rectal Cancer	Injection CNP b...	18 Years - 75 Years	Peking University People's Hospital

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