Status:
UNKNOWN
PD-1 Antibody for The Prevention of Adenomatous Polyps and Second Primary Tumors in Lynch Syndrome Patients
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Fujian Cancer Hospital
Conditions:
Lynch Syndrome
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 antib...
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 dur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT04711434
Start Date
November 1 2020
End Date
December 31 2025
Last Update
January 20 2021
Active Locations (1)
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1
Sun Yat-sen University, Cancer Center
Guangzhou, Guangdong, China, 510060