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NCT06356584
Fruquintinib Combined With Sintilimab ± Radiotherapy for Third-line Treatment of Colorectal Cancer With Liver Metastases
Phase 2 trial testing Immunotherapy (Sintilimab) in Colorectal Cancer in 62 participants. Currently enrolling.
1 October 2026
Quick facts
| Lead sponsor | Shandong Cancer Hospital and Institute |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 62 |
| Start date | 1 April 2024 |
| Primary completion | 1 October 2026 |
| Estimated completion | 1 October 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Immunotherapy (Sintilimab) — full drug profile →
- Targeted Therapy Agent (Fruquintinib) — full drug profile →
- Radiotherapy (SBRT and LDRT)
Conditions studied
- Colorectal Cancer — all drugs for Colorectal Cancer →
- Immunotherapy — all drugs for Immunotherapy →
- Radiotherapy — all drugs for Radiotherapy →
- Targeted Therapy — all drugs for Targeted Therapy →
Sponsor
Shandong Cancer Hospital and Institute
Who can join
Adults 18 to 75, any sex, with Colorectal Cancer or Immunotherapy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Colorectal cancer (CRC) is a significant cause of morbidity and mortality worldwide. Its early clinical manifestations are often subtle, leading to late-stage diagnosis in about 30% of cases with distant metastases. Liver metastases are widespread and associated with poor prognosis, especially in terms of response to immunotherapy. This prospective study will evaluate the efficacy of combined therapy involving sintilimab, fruquintinib, and radiotherapy in CRC with liver metastases. The primary objectives are to assess progression-free survival, overall survival, and treatment response rates. This study aims to provide valuable insights into optimizing third-line and subsequent therapies for CRC with liver metastases by elucidating the efficacy and safety of this combined treatment approach.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Current and emerging concepts for systemic treatment of metastatic colorectal cancer.
Steup C, Kennel KB, Neurath MF, Fichtner-Feigl S, et al · · 2025 · cited 10× · PMID 41047178 · DOI 10.1136/gutjnl-2025-335412 -
Clinical Progress of Fruquintinib in Colorectal Cancer: An Overview.
Xie Y, Tang S, Qin Z, Yang C. · · 2025 · cited 3× · PMID 40006092 · DOI 10.3390/ph18020280 -
Sintilimab plus fruquintinib with or without radiotherapy for third-line treatment of colorectal cancer with liver metastases: study protocol for a randomized controlled, multicenter phase II trial.
Ma Z, Zhu K, Shi F, Feng R, et al · · 2026 · PMID 42206059 · DOI 10.3389/fimmu.2026.1622828
Verify or expand the search:
- PubMed search for NCT06356584
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT06356584 (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 Shandong Cancer Hospital and Institute
- Last refreshed: 26 June 2025
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/NCT06356584.
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