Combining radiotherapy with Surufatinib and Sintilimab for high-risk localized soft tissue sarcoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.