MedTrace Logo

PD-1 Antibody for The Prevention of Adenomatous Polyps and Second Primary Tumors in Lynch Syndrome Patients

NCT04711434 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2021-01-20

No results posted yet for this study

Summary

This study aims to explore the role of PD-1 Antibody in preventing adenomatous polyps and second primary tumors in patients with Lynch Syndrome. There two arms, one is the experimental arm (PD-1 antibody prevention group) and the other is the control arm (routine follow-up group). For the experimental group, Tripleitriumab (PD-1 antibody) is given every 3 months for a year.

Conditions

Interventions

DRUG

PD-1 Antibody

Toripalimab: 240mg IV every 3 months for a year

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    collaborator OTHER

  • Fujian Cancer Hospital

    collaborator OTHER_GOV

  • Guangdong Provincial People's Hospital

    collaborator OTHER

  • Guangdong Provincial Hospital of Traditional Chinese Medicine

    collaborator OTHER

  • The Third Affiliated Hospital of Kunming Medical College.

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Peirong Ding, MD, Ph D · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2023-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04711434 on ClinicalTrials.gov