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High-Risk Localized Soft Tissue SarcomaPhase 1/2IRISNCT05839275

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

A Phase 1/2 study testing Surufatinib, Sintilimab and Radiotherapy in people with High-Risk Localized Soft Tissue Sarcoma, run by Fudan University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
High-Risk Localized Soft Tissue Sarcoma
What is being tested?
Surufatinib, Sintilimab and Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteChina
Study dates
1 Aug 2022to 31 Jul 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yan Wang, M.D, PH.D contact

18121299388

wangxyyan@sina.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Zhen Zhang, M.D, PH.D, 19521280960, zhen_zhang@fudan.edu.cn

    Recruiting

Other trials in China

About this study

Official title: 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.

Being tested
Surufatinib, Sintilimab, Radiotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurufatinibDrug

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

  • SintilimabDrug

    200mg, d1, q3w

  • RadiotherapyRadiation

    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).

Study groups in NCT05839275
Study groupRoleWhat they receive
Treatment ArmExperimentalThere will be 52 patients with high-risk localized extremity and truncal soft tissue sarcoma recruited. In safety lead-in phase (phase Ib): using 3+3 design, patients will receive 6 cycles of Surufatinib in three different dosages and Sintilimab. And radiotherapy will begin in week 4. In extended phase (phase II): Surufatinib in RP2D, Sintilimab and radiotherapy will be applied as before.
Receives: Drug: Surufatinib; Drug: Sintilimab; Radiation: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    The percentage of patients with objective response. Objective response is defined as complete response (CR) or partial response (PR) per response evaluation criteria (RECIST v1.1) before surgery.

    Measured: The objective response rate (ORR) will be evaluated before surgery.

Secondary outcomes (10)

  1. Pathological Complete Response (pCR) and Near pCR Rate

    The proportion of subjects whose pathological response rate of tumor tissue in postoperative specimens is ≥90% after preoperative treatment.

    Measured: The pathologic complete response (pCR) rate will be evaluated from surgical samples, immediately after surgery.

  2. Non-Perfused Volume (NPV)

    The changes in tumour volume that are not enhanced in imaging images with contrast agent before and after treatment.

    Measured: The non-perfused volume (NPV) will be measured in four weeks before preoperative treatment and before surgery in week18-21.

  3. Adverse Events

    The toxic reactions are evaluated and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Edition 5 (NCI-CTCAE V. 5).

    Measured: From the beginning of treatment to 90 days after the end of the last treatment.

  4. Wound Complications

    Postoperative incision healing, with reference to the Canadian study for grading of wound complications.

    Measured: Up to 120 days from the surgery.

  5. Local Control Rate

    The proportion of subjects who recurred within the radiotherapy exposure field from the start of treatment to the imaging assessment of all evaluable subjects.

    Measured: From the start of treatment to local recurrence, up to 5 years.

  6. Progression-Free Survival (PFS)

    The time from initiation of treatment to PD or death from any cause.

    Measured: Up to 5 years

  7. Overall Survival (OS)

    The time from initiation of treatment to death from any cause.

    Measured: Up to 5 years

  8. Quality of Life (QoL) according to the Musculoskeletal Tumor Society (MSTS)

    The Musculoskeletal Tumor Society (MSTS) is a measure of physical function across 7 items, including pain, range of motion, strength, joint stability, joint deformity, emotional acceptance, and overall function. Each item is scored from 0(worst) to 5(best) with a maximum possible score of 35, which is converted to a scale from 0 to 100 points

    Measured: Quality of Life (QoL) will be evaluated at least five times: before treatment, at 3, 6, 12 and 24 months respectively after surgery.

  9. Quality of Life (QoL) according to the Toronto Extremity Salvage Score (TESS)

    The Toronto Extremity Salvage Score (TESS) is a self-administered questionnaire evaluating possible limitations in physical activity. A total of 30 questions are included in the TESS, and the degree of disability is rated from 0 (complete disability) to 5 (no functional impairment) in each item

    Measured: Quality of Life (QoL) will be evaluated at least five times: before treatment, at 3, 6, 12 and 24 months respectively after surgery.

  10. Quality of Life (QoL) according to the Short Form (SF)-36 questionnaires

    The Short Form (SF)-36 questionnaires is a 36-item health survey status which is composed of the following eight domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each of these domains can be rated from 0 (worst) to 100 (best). The final SF-36 score is converted to a 0-100 points range scale

    Measured: Quality of Life (QoL) will be evaluated at least five times: before treatment, at 3, 6, 12 and 24 months respectively after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2023
  2. Study start1 Aug 2022
  3. Primary completion31 Jul 2024 (estimated)
  4. Study completion31 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05839275
Sponsor's protocol ID
FDRT-2021-328-2631-A1
Acronym
IRIS
Status last verified
Aug 2023
First submitted
10 Apr 2023
Last updated
21 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Surufatinib, Sintilimab and Radiotherapy in people with High-Risk Localized Soft Tissue Sarcoma, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yan Wang, M.D, PH.D (18121299388, wangxyyan@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: The objective response rate (ORR) will be evaluated before surgery.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05839275.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.

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