Preventing adenomatous polyps and tumors in Lynch Syndrome patients using PD-1 antibody
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
This study is testing if a new antibody treatment can help prevent polyps and tumors in people with Lynch Syndrome.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, Tripleitriumab, Toripalimab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04711434 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of the PD-1 antibody, Toripalimab, in preventing adenomatous polyps and second primary tumors in patients diagnosed with Lynch Syndrome. Participants are divided into two groups: one receiving the PD-1 antibody every three months for a year, and the other undergoing routine follow-up without drug intervention. The study aims to assess the incidence of intestinal adenomatous polyps and secondary tumors over a five-year period, with a focus on both primary and secondary outcomes related to cancer prevention and patient survival. The research is crucial due to the hereditary nature of Lynch Syndrome and its associated cancer risks.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-70 with Lynch Syndrome and specific germline variants who have completed necessary cancer treatments.
Not a fit: Patients with Lynch Syndrome variants MSH6 and PMS2 or those who have previously undergone immunotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of colorectal and other cancers in patients with Lynch Syndrome.
How similar studies have performed: While there have been studies on PD-1 antibodies in cancer treatment, this specific preventive approach in Lynch Syndrome is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Lynch syndrome with germline variants of MLH1, MSH2, or EPCAM (pathogenic or likely pathogenic variants) 2. Necessary treatments have been done, such as surgery, chemotherapy, radiation therapy, etc. 3. Have a resection, including right hemicolectomy, left hemicolectomy, sigmoid colectomy, or anterior resection of rectal cancer, or endoscopic adenoma resection 4. Aged 18-70 years old 5. Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1 6. White blood cell (WBC) \> 4000/mm3, Platelet count \>100000/mm3, HB \>10 g/dL 7. 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 8. Serum creatinine (Scr) \<1.8 mg/dL Exclusion Criteria: 1. Lynch syndrome with germline variants of MSH6 and PMS2 2. Previous immunotherapy has been taken, such as anti-PD-1, anti-PD-L1, etc. 3. Long-term use of aspirin 4. Suffering from autoimmune diseases 5. Active infection with hepatitis B or hepatitis C (high copy number of viral DNA) or human immunodeficiency virus (HIV) 6. Other clinically serious active infections (NCI-CTC 4.0) 7. With cachexia or organ dysfunction 8. Suffering from seizures requiring treatment (such as steroids or antiepileptic therapy) 9. Unable to participate or complete the study due to substance abuse, or medical, psychological, or social disorder 10. Known allergy to any drugs in this study 11. Pregnant or nursing women, or women of childbearing potential who are not using adequate contraception 12. Any unstable condition or situation that could compromise the safety and compliance of participants. 13. Failure to sign an informed consent form
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University, Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Peirong Ding, MD, Ph D
- Email: dingpr@sysucc.org.cn
- Phone: 00862087343124
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.