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NCT06045286: HaRyPOT
High- and Low-dose Radiotherapy Combined With PD-1 Inhibitors for MSS CRLM
Phase 1 trial testing Radiation: High- and Low-dose radiotherapy in Colorectal Liver Metastases in 30 participants. Status unknown.
30 September 2024
Quick facts
| Lead sponsor | Jiangsu Cancer Institute & Hospital |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 20 September 2023 |
| Primary completion | 30 September 2024 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Radiation: High- and Low-dose radiotherapy
- PD-1 Inhibitors — full drug profile →
Conditions studied
- Colorectal Liver Metastases — all drugs for Colorectal Liver Metastases →
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):
-
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT06045286
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Colorectal Liver Metastases
Currently open trials in the same condition.
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- NCT07117435 — Paclitaxel Cationic Liposome (Hepatic Arterial Infusion) in Combination With Systemic Therapy as First-Line Treatment in · Phase 1 · recruiting
- NCT06638502 — Safety of HRX215 in Patients After Minor and Major Liver Resection · Phase 1, PHASE2 · recruiting
- NCT05265169 — Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM) · NA · recruiting
Other Jiangsu Cancer Institute & Hospital trials
Trials by the same sponsor.
- NCT07408609 — Perioperative Chemotherapy With Low-Dose Radiotherapy and Tislelizumab for Locally Advanced Gastric or Gastroesophageal · Phase 2 · not yet recruiting
- NCT07407452 — Iparomlimab and Tuvonralimab (QL1706) Combined With Standard Chemotherapy or Combined With Intraperitoneal Perfusion Che · Phase 2 · not yet recruiting
- NCT07446387 — A Clinical Study of Iparomlimab and Tuvonralimab Combined With Bevacizumab and Alternating Triweekly CAPOX/mCAPIRI Regim · Phase 2 · not yet recruiting
- NCT07311577 — Disitamab Vedotin Combined With Platinum and Bevacizumab as First-Line and Maintenance Therapy for HER2-Expressing, HRD- · Phase 2 · recruiting
- NCT05912582 — Prospective Study for Molecular Biomarkers and Spatial Transcriptomics of Nasopharyngeal Carcinoma · 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 NCT06045286 (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 Jiangsu Cancer Institute & Hospital
- Last refreshed: 21 September 2023
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/NCT06045286.
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