Combining radiotherapy with Surufatinib and Sintilimab for 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)
This study is testing a new treatment that combines radiotherapy with two medications, Surufatinib and Sintilimab, to see if it can help people with high-risk localized soft tissue sarcoma.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, Sintilimab, Surufatinib |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05839275 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of a treatment regimen that combines radiotherapy with Surufatinib, a small-molecule tyrosine kinase inhibitor, and Sintilimab, an anti-PD1 antibody, in patients diagnosed with high-risk localized soft tissue sarcoma. The study is designed as a two-stage process, starting with a safety lead-in phase (Phase Ib) that utilizes a 3+3 design to determine the appropriate dosing of the medications. Following this, the extended phase (Phase II) will assess the treatment's effectiveness based on the recommended phase 2 dose established in the initial phase. A total of 52 patients will be recruited for this single-center trial.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 70 with high-risk localized soft tissue sarcoma that is either borderline resectable or unresectable.
Not a fit: Patients with distant metastases or specific histological types of sarcoma such as osteosarcoma or malignant mesothelioma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could provide a new effective option for patients with high-risk localized soft tissue sarcoma.
How similar studies have performed: While this approach combines established treatments, the specific combination of Surufatinib and Sintilimab with radiotherapy in this context is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged from 18 to 70, with life expectancy more than 2 years * Histologically confirmed STS, G2 or G3 * Has imaging-confirmed localized lesions on the limbs or trunk without distant metastases * Has\>5 cm lesions, or the lesions are determined to be borderline resectable or unresectable by a multidisciplinary consultation. * Experience local recurrence after surgery (disease-free survival more than 2 months after surgery) or primary tumor * ECOG performance status 0-1 * Demonstrate adequate organ function (bone marrow, liver, kidney and clotting function) within 7 days before the first administration without using blood products or hematopoietic stimulating factors. * Fully informed and willing to provide written informed consent for the trial Exclusion Criteria: * The presence of regional or distant metastases detected by imaging evaluation * The following histological types: osteosarcoma, chordoma, classic chondrosarcoma, Kaposi's sarcoma, malignant mesothelioma, radiation-induced sarcomas * History of another primary malignant tumor within the past three years or at the same time (excluding localized basal cell carcinoma, cutaneous squamous cell carcinoma, ductal carcinoma in situ, lobular carcinoma in situ, adenocarcinoma in situ of cervix, or other previous malignant tumor with a disease-free survival of more than 10 years) * Receiving any other chemotherapy or targeted therapy within 4 weeks before enrollment * Prior treatment using anti-PD1 immunotherapy * Prior radiotherapy towards the target lesion or has other contraindications to radiotherapy or surgery * Baseline laboratory indicators do not meet the following criteria: neutrophils ≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L , ALT ≤2.5 ULN, AST ≤2.5 ULN, Cr≤ 1.5 ULN or creatinine clearance rate \<50ml/min, TBIL ≤1.5 ULN, APTT≤1.5 ULN, PT ≤1.5 ULN * Urinary protein ≥ 2+, or 24-hour urine protein ≥1.0g/24h * Uncontrolled hypertension: SBP \>140mmHg or DBP \> 90mmHg * Uncontrolled hyperglycemia or coagulation disorder * Active infection requiring systemic anti-infective therapy * Uncontrolled mental diseases * Previous surgery within 2 weeks of before enrollment (excluding diagnostic biopsy or peripherally inserted central catheter implantation) * History of immunodeficiency diseases or active autoimmune disease requiring systemic treatment * Pregnant or lactating women * Allergic to any component of the therapy
Where this trial is running
Shanghai, Shanghai Municipality
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Zhen Zhang, M.D, PH.D — Fudan University
- Study coordinator: Yan Wang, M.D, PH.D
- Email: wangxyyan@sina.com
- Phone: 18121299388
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.