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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Adriamycin and Ifosfamide Combined With Sintilimab

An Open, Multi-center, Randomized, Phase II Study of Adriamycin and Ifosfamide Combined With Sintilimab in the Treatment of Advanced or Unresectable Soft Tissue Sarcoma

Adriamycin and Ifosfamide Combined With Sintilimab (NCT04589754) is a Phase 2 interventional studying Soft Tissue Sarcoma, sponsored by Sun Yat-sen University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The aim of this study was to explore the efficacy and safety of adriamycin and ifosfamide combined with sintilimab versus chemotherapy in the treatment of advanced or unresectable soft tissue sarcoma.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Soft Tissue Sarcoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 176 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Soft Tissue Sarcoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Patients voluntarily participated in the study and signed willing to sign a consent form; All advanced or non resectable soft tissue sarcomas confirmed by pathology failed or did not have standard treatment or could not tolerate standard treatment, Have at least one according to RECIST 1.1 the standard measurable lesions mainly included synovial sarcoma, leiomyosarcoma, alveolar soft tissue sarcoma, undifferentiated pleomorphic sarcoma / malignant fibrous histiocytoma, liposarcoma, fibrosarcoma, clear cell sarcoma, angiosarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumor, undifferentiated sarcoma, dermatofibrosarcoma protuberans, inflammatory myofibroblastic sarcoma Malignant solitary fibroma, sarcoma after radiotherapy. However, there are no standard treatment types, such as alveolar soft tissue sarcoma, post radiotherapy sarcoma, highly differentiated / dedifferentiated / pleomorphic liposarcoma, clear cell sarcoma, etc.; except for the following types: chondrosarcoma, osteosarcoma, malignant mesothelioma, gastrointestinal stromal tumor, etc; 2. Advanced patients with unresectable lesions or lymph nodes or distant metastasis assessed by imaging; 3. In the past three months, there was at least one measurable target lesion according to RECIST version 1.1 standard, and it can be accurately measured by magnetic resonance imaging (MRI) or computer tomography (CT) in at least one direction (the maximum diameter needs to be recorded), with conventional CT ≥ 20 mm or spiral CT ≥ 10 mm. 4. They were 14-70 years old; ECoG PS score: 0-1; the expected survival time was more than 3 months; 5. Within 7 days before treatment, the main organ functions met the following criteria: (1) Blood routine examination standard (without blood transfusion within 14 days) ① Hemoglobin (HB) ≥ 90g / L; ② The absolute value of neutrophil (ANC) ≥ 1.5 × 109 / L; - Platelet (PLT) ≥ 80 × 109 / L. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Patients voluntarily participated in the study and signed informed consent; All advanced or non resectable soft tissue sarcomas confirmed by pathology failed or did not have standard treatment or could not tolerate standard treatment, Have at least one according to RECIST 1.1 the standard measurable lesions mainly included synovial sarcoma, leiomyosarcoma, alveolar soft tissue sarcoma, undifferentiated pleomorphic sarcoma / malignant fibrous histiocytoma, liposarcoma, fibrosarcoma, clear cell sarcoma, angiosarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumor, undifferentiated sarcoma, dermatofibrosarcoma protuberans, inflammatory myofibroblastic sarcoma Malignant solitary fibroma, sarcoma after radiotherapy. However, there are no standard treatment types, such as alveolar soft tissue sarcoma, post radiotherapy sarcoma, highly differentiated / dedifferentiated / pleomorphic liposarcoma, clear cell sarcoma, etc.; except for the following types: chondrosarcoma, osteosarcoma, malignant mesothelioma, gastrointestinal stromal tumor, etc; 2. Advanced patients with unresectable lesions or lymph nodes or distant metastasis assessed by imaging; 3. In the past three months, there was at least one measurable target lesion according to RECIST version 1.1 standard, and it can be accurately measured by magnetic resonance imaging (MRI) or computer tomography (CT) in at least one direction (the maximum diameter needs to be recorded), with conventional CT ≥ 20 mm or spiral CT ≥ 10 mm. 4. They were 14-70 years old; ECoG PS score: 0-1; the expected survival time was more than 3 months; 5. Within 7 days before treatment, the main organ functions met the following criteria: (1) Blood routine examination standard (without blood transfusion within 14 days) ① Hemoglobin (HB) ≥ 90g / L; ② The absolute value of neutrophil (ANC) ≥ 1.5 × 109 / L; * Platelet (PLT) ≥ 80 × 109 / L. (2) Biochemical examination should meet the following standards: ① Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); ② Alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5uln, such as With liver metastasis, ALT and AST ≤ 5uln; ③ Serum creatinine (CR) ≤ 1.5uln or creatinine clearance rate (CCR) ≥ 60ml / min; (3) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ the lower limit of normal value (50%). Women of childbearing age should agree that contraceptive measures (such as intrauterine device, contraceptive or condom) must be used during the study period and within 6 months after the end of the study; serum or urine pregnancy test negative within 7 days before study enrollment, and must be non lactating patients; men should agree that contraceptive measures must be used during the study period and within 6 months after the end of the study period. Exclusion Criteria: 1\) Patients who had previously received anti-PD-1 / PD-L1 antibody therapy. 2\) Other malignancies occurred or were present within 5 years, except for cervical carcinoma in situ, non melanoma skin cancer and superficial bladder tumor \[ta (non invasive tumor), tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\]; 3\) The patients with thyroid dysfunction after the best drug treatment; 4\) Systemic anti-tumor therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or mitomycin C within 6 weeks prior to the trial drug treatment) was planned within 4 weeks before enrollment or during the study period. Over extended field radiotherapy (ef-rt) was performed within 4 weeks before admission or limited field radiotherapy (rfrt) was performed within 2 weeks before grouping; 5\) With pleural effusion or ascites, it causes respiratory syndrome (≥ CTC AE grade 2 dyspnea \[grade 2 dyspnea refers to shortness of breath with a small amount of activity; it affects instrumental activities of daily living\]); 6\) Any unrelieved toxic reaction higher than CTC AE (4.01) grade 1 or above caused by previous treatment, excluding alopecia; 7\) Patients with any severe and / or uncontrolled disease, including: 1. Patients with poor blood pressure control (SBP ≥ 150 mmHg, DBP ≥ 100 mmHg); 2. Patients with myocardial ischemia or myocardial infarction of grade I or above, arrhythmia (including QTc ≥ 480ms) and congestive heart failure (NYHA) grade ≥ 2; 3. Active or uncontrolled severe infection (≥ CTC AE Level 2 infection); 4. Chronic liver disease, decompensated liver disease or decompensated hepatitis; 5. Renal failure needs hemodialysis or peritoneal dialysis; 6. Poor control of diabetes mellitus (FBG \> 10mmol / L); 7. Urine routine examination showed that urine protein was ≥ + +, and 24-hour urine protein was more than 1.0 G; 8. Patients with epilepsy and need treatment; 8\) Major surgical treatment, open biopsy or obvious traumatic injury were performed within 28 days before admission; 9\) Patients with any physical signs or history of bleeding regardless of severity; patients with any bleeding or bleeding events ≥ CTCAE 3 within 4 weeks before enrollment had unhealed wounds, ulcers or fractures; 10\) Patients who had AVT events within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism; 11\) There were active ulcer, intestinal perforation and intestinal obstruction; 12\) Subjects with clinical symptoms of central nervous system metastasis (such as brain edema, need for hormone intervention, or brain metastasis progression); patients who have previously received treatment for brain or meningeal metastasis, such as clinical stability (MRI) for at least 2 months, and who have stopped systemic hormone therapy (dose \> 10mg / day, prednisone or other effective hormones) for more than 2 weeks can be included; 13\) The subjects were using immunosuppressive agents, or systemic or absorbable local hormone therapy to achieve the purpose of immunosuppression (dosage \> 10mg / D, prednisone or other effective hormones), and continued to use them within 2 weeks before enrollment; 14\) Subjects with any active autoimmune disease or history of autoimmune diseases (e.g., but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; if the subject has vitiligo or asthma has been completely relieved in childhood, it is not necessary to be an adult Any intervention can be included; asthma patients who need bronchodilator for medical intervention cannot be included); 15\) The subjects had active tuberculosis; 16\) According to the judgment of the researcher, the subjects are not suitable to be enrolled or there are other factors that may lead to termination of the study, such as other serious diseases (including mental diseases) requiring combined treatment, serious laboratory examination abnormalities, and family or social factors, which will affect the safety of the subjects, or the collection of test data and samples; 17\) Patients who participated in other clinical trials of anti-tumor drugs within 28 days before enrollment.

Treatments Being Tested

DRUG

Sintilimab plus chemotherapy

AI regimen chemotherapy (ADM 50 mg / m2, D1 + IFO 2.5 g / m2, D1-3, IV drip) was used for 3 weeks; CAV / IE regimen alternate chemotherapy (regimen 1: CTX 1.2mg/m2 D1 + ADM 50mg / m2 D1 + VCR 1.4mg/m2 D1 and regimen 2: IFO 1.5g/m2 D1-5 + VP-16 100mg / m2 D1-5, IV drip). Regimen 1 and 2 were performed alternately, with a cycle of 3 weeks; sintilimab (10ml; 100mg) was administered intravenously every 3 weeks.

DRUG

Adriamycin-based chemotherapy

AI regimen chemotherapy (ADM 50 mg / m2, D1 + IFO 2.5 g / m2, D1-3, IV drip) was used for 3 weeks; CAV / IE regimen alternate chemotherapy (regimen 1: CTX 1.2mg/m2 D1 + ADM 50mg / m2 D1 + VCR 1.4mg/m2 D1 and regimen 2: IFO 1.5g/m2 D1-5 + VP-16 100mg / m2 D1-5, IV drip). Regimen 1 and 2 were performed alternately, with a cycle of 3 weeks.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Xing Zhang
Guangzhou, Guangdong, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04589754), the sponsor (Sun Yat-sen University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04589754 clinical trial studying?

The aim of this study was to explore the efficacy and safety of adriamycin and ifosfamide combined with sintilimab versus chemotherapy in the treatment of advanced or unresectable soft tissue sarcoma. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04589754?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04589754?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04589754. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04589754. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.