RecruitingPhase 1Phase 2NCT05839275

The Combination of Radiotherapy，Surufatinib and Sintilimab in High-Risk Localized Soft Tissue Sarcoma

A Prospective Phase Ib/II Trial of Radiotherapy Combined With Tyrosine Kinase Inhibitor and Immune Checkpoint Inhibitor in High-Risk Localized Soft Tissue Sarcoma (IRIS)

Sponsor

Fudan University

Enrollment

52 participants

Start Date

Aug 1, 2022

Study Type

INTERVENTIONAL

Conditions

High-Risk Localized Soft Tissue Sarcoma

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of radiation therapy, surufatinib (a targeted drug that cuts off blood supply to tumors), and sintilimab (an immunotherapy drug) for people with high-risk soft tissue sarcoma — aggressive tumors of muscles, fat, or connective tissue on the limbs or torso. **You may be eligible if...** - You are 18 to 70 years old with a life expectancy of more than 2 years - You have confirmed high-grade soft tissue sarcoma (Grade 2 or 3) on the limbs or trunk - Your tumor is larger than 5 cm, or has been deemed difficult or impossible to fully remove by surgery - The cancer is localized (not spread to distant organs) **You may NOT be eligible if...** - Your tumor has spread to distant organs - You have a history of significant heart, liver, or kidney disease - You have had prior targeted therapy or immunotherapy for this cancer - You have an active autoimmune disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSurufatinib

In phase Ib: 250mg, 200mg, d1-21，qd; In phase II: recommended phase 2 dose (RP2D), d1-21，qd.

DRUGSintilimab

200mg, d1, q3w

RADIATIONRadiotherapy

BED=50-60Gy (α/β=10); Radiation dose depends on tumor characteristics and organs at risk. Starts at the begin of the second cycle of systemic therapy (week 4 of the therapy).

Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT05839275

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