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NCT04711434
PD-1 Antibody for The Prevention of Adenomatous Polyps and Second Primary Tumors in Lynch Syndrome Patients
Phase 3 trial testing PD-1 Antibody in Lynch Syndrome in 260 participants. Status unknown.
31 December 2023
Quick facts
| Lead sponsor | Sun Yat-sen University |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 260 |
| Start date | 1 November 2020 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- PD-1 Antibody — full drug profile →
Conditions studied
- Lynch Syndrome — all drugs for Lynch Syndrome →
Sponsor
Sun Yat-sen University
Who can join
Adults 18 to 70, any sex, with Lynch Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Optimizing immunotherapy for colorectal cancer.
Ganesh K. · · 2022 · cited 83× · PMID 34907331 · DOI 10.1038/s41575-021-00569-4 -
Lynch Syndrome: From Carcinogenesis to Prevention Interventions.
Gambini D, Ferrero S, Kuhn E. · · 2022 · cited 15× · PMID 36077639 · DOI 10.3390/cancers14174102 -
Personalized Systemic Therapies in Hereditary Cancer Syndromes.
Mastrodomenico L, Piombino C, Riccò B, Barbieri E, et al · · 2023 · cited 9× · PMID 36980956 · DOI 10.3390/genes14030684 -
Deficient Mismatch Repair and Microsatellite Instability in Solid Tumors.
Awosika JA, Gulley JL, Pastor DM. · · 2025 · cited 6× · PMID 40362635 · DOI 10.3390/ijms26094394 -
Focus on PD-1/PD-L1-Targeting Antibodies in Colorectal Cancer: Are There Options Beyond Dostarlimab, Nivolumab, and Pembrolizumab? A Comprehensive Review.
Kciuk M, Wanke K, Kruczkowska W, Marciniak B, et al · · 2025 · cited 3× · PMID 40649207 · DOI 10.3390/molecules30132686 -
Repurposing Drugs for Cancer Prevention: Targeting Mechanisms Common to Chronic Diseases.
Choradia N, Szabo E. · · 2024 · cited 1× · PMID 39312454 · DOI 10.1097/ppo.0000000000000746 -
Immune-checkpoint inhibition for tumor prevention in a preclinical Lynch syndrome model.
Wolff A, Maennicke J, Huehns M, Krone P, et al · · 2025 · PMID 40674934 · DOI 10.1016/j.tranon.2025.102472
Verify or expand the search:
- PubMed search for NCT04711434
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT04796857 — Tislelizumab in Combination With Lenalidomide in Refractory and Relapsed Elderly Patients With Non-GCB DLBCL · Phase 1, PHASE2 · unknown
- NCT04301557 — PD1 Antibody Toripalimab and Chemoradiotherapy for dMMR/MSI-H Locally Advanced Colorectal Cancer · Phase 2 · active not recruiting
Other recruiting trials for Lynch Syndrome
Currently open trials in the same condition.
- NCT07163403 — First in Human Pilot Study to Assess the Safety and Efficacy of Dendritic Cells Loaded With Frameshift Derived Neopeptid · Phase 1 · recruiting
- NCT06582914 — Lynch Syndrome Integrative Epidemiology and Genetics · recruiting
- NCT06447961 — PSYLIVED: the Psychological Impacts of Living With an Inherited Colorectal Cancer Predisposition Syndrome · recruiting
- NCT05963191 — CAD-EYE System for the Detection of Neoplastic Lesions in Patients With Lynch Syndrome · NA · recruiting
- NCT06712095 — Video Capsule Examination in Patients With Lynch Syndrome · NA · recruiting
Other Sun Yat-sen University trials
Trials by the same sponsor.
- NCT07255612 — Bone Marrow Protection, Safety, Efficacy of Trilaciclib and Eribulin in Locally Advanced or Metastatic TNBC(Triple-negat · Phase 2 · not yet recruiting
- NCT07371897 — Toripalimab ± Chemo as Neoadjuvant Therapy in LA-HNSCC: A Phase III Trial · Phase 3 · not yet recruiting
- NCT07489703 — SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLC · Phase 2 · not yet recruiting
- NCT07528209 — Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer · Phase 3 · recruiting
- NCT07522281 — Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04711434 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sun Yat-sen University
- Last refreshed: 20 January 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04711434.
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