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NCT05839275: IRIS
The Combination of Radiotherapy，Surufatinib and Sintilimab in High-Risk Localized Soft Tissue Sarcoma
Phase 1, PHASE2 trial testing Surufatinib in High-Risk Localized Soft Tissue Sarcoma in 52 participants. Currently enrolling.
31 July 2024
Quick facts
| Lead sponsor | Fudan University |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 52 |
| Start date | 1 August 2022 |
| Primary completion | 31 July 2024 |
| Estimated completion | 31 July 2029 |
| Sites | 1 location across China |
Drugs / interventions tested
- Surufatinib — full drug profile →
- Sintilimab — full drug profile →
- Radiotherapy — full drug profile →
Conditions studied
- High-Risk Localized Soft Tissue Sarcoma — all drugs for High-Risk Localized Soft Tissue Sarcoma →
Sponsor
Fudan University
Who can join
Adults 18 to 70, any sex, with High-Risk Localized Soft Tissue Sarcoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a prospective, single-center, single-arm, phase Ib/II clinical trial. The study aims to evaluate the safety and efficacy of the treatment which combines radiotherapy, Sintilimab (Anti-PD1 Antibody) and Surufatinib (small-molecule Tyrosine Kinase inhibitor) in patients with high-risk localized soft tissue sarcoma. There will be 52 patients with high-risk localized extremity and trunck soft tissue sarcoma recruited. The trail is designed as a two-stage study. In safety lead-in phase (phase Ib), using 3+3 design, 6 cycles of Surufatinib (250mg, 200mg, qd) and Sintilimab (200mg, q3w) will be applied. And radiotherapy (BED=50-60Gy (α/β=10)) will begin in week 4 of the therapy. In extended phase (phase II), Surufatinib will be applied in the recommended phase 2 dose (RP2D) according to phase Ib. And 200mg Sintilimab and radiotherapy will be applied as before. The dose-limiting toxicity (DLT) in phase Ib and objective response rate (ORR) in phase Ib+Phase II will be mainly analyzed.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Biomarkers for immune checkpoint inhibition in sarcomas - are we close to clinical implementation?
Yiong CS, Lin TP, Lim VY, Toh TB, et al · · 2023 · cited 26× · PMID 37612756 · DOI 10.1186/s40364-023-00513-5 -
MAPK-targeted therapies in non-gastrointestinal stromal tumor soft tissue sarcomas: current landscape and future directions.
Al Jarroudi O, El Bairi K, Brahmi SA, Afqir S. · · 2025 · PMID 40909947 · DOI 10.3389/fonc.2025.1418537
Verify or expand the search:
- PubMed search for NCT05839275
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Surufatinib
Trials testing the same drug.
- NCT07469956 — Surufatinib Plus mFOLFIRINOX and PD-1 Inhibitor as the Neoadjuvant Therapy for High-risk or Borderline Resectable Pancre · Phase 2 · not yet recruiting
- NCT07272512 — Prospective Multicenter Real-world Study of Surufatinib in Patients With Advanced Neuroendocrine Neoplasms · Phase 4 · recruiting
- NCT07357623 — Surufatinib Combined With Chemo Versus Surufatinib in the Treatment of Pulmonary Neuroendocrine Tumors · Phase 2 · recruiting
- NCT07086456 — Combination of Concurrent Chemoradiotherapy With Surufatinib and Tislelizumab in Patients With Locally Advanced Non-Smal · Phase 2 · recruiting
- NCT06531291 — Surufatinib Combined With Serplulimab and Standard Chemotherapy as First-line Treatment in Advanced Solid Tumors With Ne · Phase 2 · not yet recruiting
Other recruiting trials for High-Risk Localized Soft Tissue Sarcoma
Currently open trials in the same condition.
- NCT05774275 — The Combination of Radiotherapy, Chemotherapy and Immunotherapy in High-Risk Localized Soft Tissue Sarcoma · Phase 1, PHASE2 · recruiting
Other Fudan University trials
Trials by the same sponsor.
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- NCT07410559 — Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Bre · Phase 2 · not yet recruiting
- NCT07490119 — Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer · Phase 2 · not yet recruiting
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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 NCT05839275 (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 Fudan University
- Last refreshed: 21 August 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/NCT05839275.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing