Tests radiotherapy, chemotherapy and immunotherapy together for high-risk soft tissue sarcoma
Tests combined radiotherapy, chemotherapy and immunotherapy in adults with localized soft tissue sarcoma.
Key facts
- Who runs it
- Fudan University
- Where
- Shanghai, ChinaSee the site
- Trial code
- Registry title
- The Combination of Radiotherapy, Chemotherapy and Immunotherapy in High-Risk Localized Soft Tissue Sarcoma
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 52 people, planned
- Started
- 25 Aug 2022
- Expected to end
- 24 Aug 2029
- Type of study
- Interventional
- Treatments tested
- Pegylated Liposomal Doxorubicin
- Doxorubicin
- Anti-PD-1 monoclonal antibody
- Radiotherapy
- Record updated
- 26 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a high-risk soft tissue sarcoma of the arms, legs or trunk that has not spread to other parts of the body. It tests radiotherapy with chemotherapy and immunotherapy before surgery.
- Age
- 18 to 75 years. Ages 18 to 70 need ECOG performance status 0-1. Ages 70 to 75 need ECOG 0. Life expectancy over 2 years.
- Sex
- All sexes can join.
- Disease stage
- Soft tissue sarcoma grade 2 or 3 on the arms, legs or trunk, with no distant spread. The tumour is larger than 5 cm (2 in), or doctors judge it borderline resectable or unresectable. It can be a first tumour or a local return after surgery.
- Earlier treatment
- If the tumour came back after surgery, the person must have been free of disease for more than 2 months after that surgery. Cannot join with other chemotherapy in the last 4 weeks, earlier anti-PD1 treatment, or earlier radiotherapy in the same area. Cannot join with major surgery in the last 2 weeks.
- Biomarker or test result
- Blood counts, liver function and kidney function must be good enough, as set in the record.
Main reasons for not taking part
- Spread to nearby lymph nodes or distant parts of the body
- Osteosarcoma, chordoma, classical chondrosarcoma, Kaposi's sarcoma, malignant mesothelioma or radiation-induced sarcoma
- Another cancer in the past three years or at the same time, with a few listed exceptions
- Active infection needing treatment, immune deficiency, or autoimmune disease needing systemic treatment
- Pregnant or breastfeeding women, and men who expect to have babies
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- Histologically confirmed STS, G2 or G3. The histological types include: pleomorphic undifferentiated sarcoma, liposarcoma, leiomyosarcoma, synovial sarcoma, myxofibrosarcoma, fibrosarcoma, angiosarcoma but not radiotherapy-induced angiosarcoma, etc
- Has>5 cm lesions, or the lesions are determined to be borderline resectable or unresectable by a multidisciplinary consultation
- Has imaging-confirmed localized lesions on the limbs or trunk without distant metastases
- Experience primary tumor or local recurrence after surgery (disease-free survival more than 2 months after surgery)
- Aged from 18 to 70, with ECOG performance status 0-1, or aged from 70 to 75, with ECOG performance status 0. Has life expectancy more than 2 years
- Demonstrate adequate organ function (bone marrow, liver, and kidney function) (Leukocytes ≥ 3 × 10\^9 /L, Neutrophils ≥ 1.5 × 10\^9 /L, Hemoglobin ≥ 90 g/L, Platelet count ≥ 100 × 10\^9 /L, Total bilirubin ≤1.5 × institutional upper limit of normal (ULN), Aspartate transaminase ≤2.5 × ULN, Alanine transaminase ≤2.5 × ULN, Serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL/min.)
- Fully informed and willing to provide written informed consent for the trial
Who cannot take part
- Known history of other chemotherapy within 4 weeks before enrolment, previous anti-PD1 treatment, previous radiotherapy in the radiation field, or has other contraindications to radiotherapy or surgery
- Previous major surgery within 2 weeks before enrolment (excluding minor operation such as diagnostic biopsy or peripherally inserted central catheter implantation)
- Patients with the following histological types: osteosarcoma, chordoma, classical chondrosarcoma, Kaposi's sarcoma, malignant mesothelioma, radiation-induced sarcomas
- Known 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 five years)
- Uncontrolled hyperglycaemia or Coagulation disorder
- Active infection requiring systemic anti-infective therapy
- Known history of immunodeficiency diseases or active autoimmune disease requiring systemic treatment
- The presences of regional or distant metastases detected by imaging evaluation
- Female patients pregnant or breastfeeding, Male patients expecting to have babies
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in China
- Fudan University Shanghai Cancer CenterShanghai, ChinaContact: Zhen Zhang, M.D, PH.DTaking people
About the trial
What the trial wants to find out
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, chemotherapy and immunotherapy in patients with high-risk localized soft tissue sarcoma.
Read full original descriptionShow less
There will be 52 patients with high-risk localized extremity and trunk soft tissue sarcoma recruited. The trail is designed as a two-stage study. In safety lead-in phase (phase Ib), using 3+3 design, 4 cycles of Pegylated Liposomal Doxorubicin (37.5 mg/m2, 30 mg/m2, q3w) or doxorubicin hydrochloride (75mg/m2, q3w), Sintilimab (200mg, q3w) and radiotherapy (BED=50-60Gy (α/β=10)) will be applied. In phase II, Pegylated Liposomal Doxorubicin 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.
The group in the trial
- Treatment ArmTreatment being tested
There will be 52 patients with high-risk localized extremity and trunk soft tissue sarcoma recruited. In safety lead-in phase (phase Ib): using 3+3 design, patients will receive 4 cycles of Pegylated Liposomal Doxorubicin or doxorubicin hydrochloride, sintilimab and radiotherapy. In phase II: Pegylated Liposomal Doxorubicin in RP2D, sintilimab and radiotherapy will be applied as before.
Treatment: Pegylated Liposomal Doxorubicin, Doxorubicin, Anti-PD-1 monoclonal antibody, and Radiotherapy
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Prospective Phase Ib/II Trial of Preoperative Radiotherapy Combined With Chemotherapy and Immunotherapy in High-Risk Localized Soft Tissue Sarcoma
- Plain-language title
- Tests radiotherapy, chemotherapy and immunotherapy together for high-risk soft tissue sarcomaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05774275, who can take part
- Record updated
- 26 May 2026