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NCT06045286: HaRyPOT

High- and Low-dose Radiotherapy Combined With PD-1 Inhibitors for MSS CRLM

Status unknown Phase 1 Last updated 21 September 2023
What this trial tests

Phase 1 trial testing Radiation: High- and Low-dose radiotherapy in Colorectal Liver Metastases in 30 participants. Status unknown.

Timeline
20 September 2023
Primary endpoint
30 September 2024
31 December 2025

Quick facts

Lead sponsorJiangsu Cancer Institute & Hospital
PhasePhase 1
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date20 September 2023
Primary completion30 September 2024
Estimated completion31 December 2025
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Jiangsu Cancer Institute & Hospital

Who can join

18 and older, any sex, with Colorectal Liver Metastases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This pilot phase I trial aims to investigate the efficacy and safety of high- and low-dose radiotherapy combined with programmed cell death-1 (PD-1) inhibitors in microsatellite stable (MSS) metastatic colorectal cancer (mCRC) that have failed second-line immunotherapy or above.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Immunotherapy in liver cancer: overcoming the tolerogenic liver microenvironment.
    Liu Y, Yang H, Li T, Zhang N. · · 2024 · cited 23× · PMID 39295859 · DOI 10.3389/fimmu.2024.1460282
  2. Emerging advances in drug delivery systems (DDSs) for optimizing cancer complications.
    Li K, Guo B, Gu J, Ta N, et al · · 2025 · cited 8× · PMID 39759851 · DOI 10.1016/j.mtbio.2024.101375
  3. Liver Extracellular Matrix in Colorectal Liver Metastasis.
    Morabito M, Thibodot P, Gigandet A, Compagnon P, et al · · 2025 · cited 4× · PMID 40149289 · DOI 10.3390/cancers17060953
  4. Understanding the Tumor Microenvironmental Mechanisms Driving Immunotherapy Resistance in Colorectal Cancer Liver Metastases.
    Cives-Losada C, Soldani C, Polidoro MA, Franceschini B, et al · · 2026 · PMID 41930154 · DOI 10.32604/or.2025.074093
  5. RT-ICI therapy induces a distal immunometabolic axis that shapes systemic macrophage polarization and enhances local T cell immunity.
    Ge Y, Liu H, Shen J, Xu H, et al · · 2026 · PMID 41654947 · DOI 10.1186/s12964-026-02689-3
  6. High and low dose radiotherapy combined with ICIs for MSS colorectal cancer patients with liver metastases: a phase I study (HaRyPOT).
    Ding Y, Feng Y, Ye Y, Shen J, et al · · 2025 · PMID 39980556 · DOI 10.3389/fonc.2025.1503517

Verify or expand the search:

Other recruiting trials for Colorectal Liver Metastases

Currently open trials in the same condition.

Other Jiangsu Cancer Institute & Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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