- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04711434
PD-1 Antibody for The Prevention of Adenomatous Polyps and Second Primary Tumors in Lynch Syndrome Patients
PD-1 Antibody for the Prevention of Adenomatous Polyps and Second Primary Tumors in Patients With Lynch Syndrome: An Open-label, Multicenter, Randomized Controlled Clinical Trial
Study Overview
Detailed Description
Lynch syndrome (LS) is a hereditary cancer syndrome that causes the majority of hereditary CRC and approximately 3% of all CRC. LS significantly increases the risk for an individual to develop CRC during their lifetime. Individuals with LS also have an increased risk to develop extracolonic cancers, including endometrial, gastric, ovarian, upper urinary tract, small bowel, biliary tract, CNS, and certain types of skin cancer. Given the hereditary nature of this syndrome, preventing second primary tumors in patients with Lynch Syndrome after surgery to the primary site is very important.
The purpose of this study is to prevent adenomatous polyps and second primary tumors using PD-1 antibody (Tripleitriumab) in patients with Lynch Syndrome.
The primary outcome of this study is the incidence of intestinal adenomatous polyps and secondary primary tumors. The secondary outcomes are the incidence of colorectal adenomatous polyps greater than 1cm, incidence of high-grade colorectal polyps, treatment-related adverse events, disease-free Survival and overall Survival.
There are two groups: the PD-1 antibody prevention group and the routine follow-up group. For the PD-1 antibody prevention group, participants will receive Toripalimab 240mg IV every 3 months for a year. For the routine follow-up group, there is no drug intervention.
This whole study will take 5 years: the first year for recruiting and the latter four years for follow-up.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Peirong Ding, MD, Ph D
- Phone Number: 00862087343124
- Email: dingpr@sysucc.org.cn
Study Contact Backup
- Name: Wu Jiang, MD, Ph D
- Phone Number: 00862087343920
- Email: jiangwu@sysucc.org.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- Recruiting
- Sun Yat-sen University, Cancer Center
-
Contact:
- Peirong Ding, MD, Ph D
- Phone Number: 00862087343124
- Email: dingpr@sysucc.org.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Lynch syndrome with germline variants of MLH1, MSH2, or EPCAM (pathogenic or likely pathogenic variants)
- Necessary treatments have been done, such as surgery, chemotherapy, radiation therapy, etc.
- Have a resection, including right hemicolectomy, left hemicolectomy, sigmoid colectomy, or anterior resection of rectal cancer, or endoscopic adenoma resection
- Aged 18-70 years old
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1
- White blood cell (WBC) > 4000/mm3, Platelet count >100000/mm3, HB >10 g/dL
- Serum glutamic-oxaloacetic transaminase (SGOT) < 1.5 × the upper limit of normal (ULN), Serum glutamic pyruvic transaminase (SGPT) < 1.5 × ULN prior to randomization, Total bilirubin (TBIL) < 1.5 mg/dL
- Serum creatinine (Scr) <1.8 mg/dL
Exclusion Criteria:
- Lynch syndrome with germline variants of MSH6 and PMS2
- Previous immunotherapy has been taken, such as anti-PD-1, anti-PD-L1, etc.
- Long-term use of aspirin
- Suffering from autoimmune diseases
- Active infection with hepatitis B or hepatitis C (high copy number of viral DNA) or human immunodeficiency virus (HIV)
- Other clinically serious active infections (NCI-CTC 4.0)
- With cachexia or organ dysfunction
- Suffering from seizures requiring treatment (such as steroids or antiepileptic therapy)
- Unable to participate or complete the study due to substance abuse, or medical, psychological, or social disorder
- Known allergy to any drugs in this study
- Pregnant or nursing women, or women of childbearing potential who are not using adequate contraception
- Any unstable condition or situation that could compromise the safety and compliance of participants.
- Failure to sign an informed consent form
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Prevention group
Toripalimab: 240mg IV every 3 months for a year
|
Toripalimab: 240mg IV every 3 months for a year
Other Names:
|
No Intervention: Follow-up group
Routine follow-up, no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The percentage of patients from randomization to the first appearance of one of the following: adenomatous polyps or second primary tumors
Time Frame: up to 5 years
|
up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The percentage of patients developing polyps greater than 1cm within 5 years from randomization
Time Frame: up to 5 years
|
up to 5 years
|
|
The percentage of patients developing high-grade polyps on pathology within 5 years from randomization.
Time Frame: up to 5 years
|
up to 5 years
|
|
Treatment-related adverse events
Time Frame: up to 5 years
|
Incidence and severity of adverse events as assessed by NCI CTCAE V4.0
|
up to 5 years
|
Effectiveness with different genotypes or phenotypes
Time Frame: up to 5 years
|
Estimated the percentage of patients with different genotypes or phenotypes not developing polyps or second primary tumors within 5 years from randomization.
|
up to 5 years
|
Disease-free Survival
Time Frame: up to 5 years
|
defined as the time from randomization to the first appearance of one of the following: primary tumor recurrence, or death without cancer event; or censored at date of last follow-up
|
up to 5 years
|
Overall Survival
Time Frame: up to 5 years
|
defined as the time from randomization to death from any cause.
Participants who were alive or lost to follow-up at the time of the analysis were censored at the date they were last known to be alive
|
up to 5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Peirong Ding, MD, Ph D, Sun Yat-sen University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Metabolic Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Disease
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Genetic Diseases, Inborn
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Colorectal Neoplasms
- Neoplastic Syndromes, Hereditary
- DNA Repair-Deficiency Disorders
- Adenoma
- Syndrome
- Colorectal Neoplasms, Hereditary Nonpolyposis
- Adenomatous Polyps
- Physiological Effects of Drugs
- Immunologic Factors
- Antibodies
Other Study ID Numbers
- B2020-059-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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