Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lynch Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1 Antibody | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prevention group
- description
- Toripalimab: 240mg IV every 3 months for a year
- interventionNames
- Drug: PD-1 Antibody
- type
- NO_INTERVENTION
- label
- Follow-up group
- description
- Routine follow-up, no intervention
Primary outcomes (1)
- measure
- The percentage of patients from randomization to the first appearance of one of the following: adenomatous polyps or second primary tumors
- timeFrame
- up to 5 years
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available