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

NCT04711434 | Unknown Phase 3

• 1 other identifier: B2020-059-01
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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

Lynch Syndrome

Keywords

Toripalimab; Lynch Syndrome; Prevention

Outcome Measures

Primary Outcomes (1)

• The percentage of patients from randomization to the first appearance of one of the following: adenomatous polyps or second primary tumors

  up to 5 years

Secondary Outcomes (6)

• The percentage of patients developing polyps greater than 1cm within 5 years from randomization

  up to 5 years

• The percentage of patients developing high-grade polyps on pathology within 5 years from randomization.

  up to 5 years

• Treatment-related adverse events

  up to 5 years

• Effectiveness with different genotypes or phenotypes

  up to 5 years

• Disease-free Survival

  up to 5 years

Study Arms (2)

Prevention group

EXPERIMENTAL

Toripalimab: 240mg IV every 3 months for a year

Drug: PD-1 Antibody

Follow-up group

NO INTERVENTION

Routine follow-up, no intervention

Interventions

PD-1 Antibody DRUG

Toripalimab: 240mg IV every 3 months for a year

Also known as: Toripalimab

Prevention group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• Fujian Cancer Hospital: collaborator
• Guangdong Provincial People's Hospital: collaborator
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator
• The Third Affiliated Hospital of Kunming Medical College.: collaborator

Study Sites (1)

Sun Yat-sen University, Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis

Interventions

spartalizumab; toripalimab

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Peirong Ding, MD, Ph D

  Sun Yat-sen University

  STUDY CHAIR

Central Study Contacts

Peirong Ding, MD, Ph D

CONTACT

00862087343124; dingpr@sysucc.org.cn

Wu Jiang, MD, Ph D

CONTACT

00862087343920; jiangwu@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 15, 2021
• Study Start: November 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: January 20, 2021

Record last verified: 2021-01

Locations

CN (1)