Tests radiotherapy with two drugs for high-risk soft tissue sarcoma
Tests radiotherapy with surufatinib and sintilimab in people with localized soft tissue sarcoma.
Plain-language title generated from the registry record
Registry title: The Combination of Radiotherapy，Surufatinib and Sintilimab in High-Risk Localized Soft Tissue Sarcoma
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT05839275, who can take part
Where in China
- Fudan University Shanghai Cancer CenterShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fudan University
- Trial code
- NCT05839275
- Record updated
- 21 August 2023
- Original 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.Read full original descriptionShow less
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 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.
Inclusion: 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: 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; Previous surgery within 2 weeks of before enrollment (excluding diagnostic biopsy or peripherally inserted central catheter implantation); 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); Uncontrolled hypertension: SBP >140mmHg or DBP > 90mmHg; Uncontrolled hyperglycemia or coagulation disorder; Active infection requiring systemic anti-infective therapy; Uncontrolled mental diseases; History of immunodeficiency diseases or active autoimmune disease requiring systemic treatment; Allergic to any component of the therapy; 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; The presence of regional or distant metastases detected by imaging evaluation; Urinary protein ≥ 2+, or 24-hour urine protein ≥1.0g/24h; Pregnant or lactating women.