Soft Tissue SarcomaPhase 2NCT04589754
Adriamycin and Ifosfamide Combined With Sintilimab
A Phase 2 study testing Sintilimab plus chemotherapy and Adriamycin-based chemotherapy in people with Soft Tissue Sarcoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- Sintilimab plus chemotherapy and Adriamycin-based chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 1 siteChina
- Study dates
- 26 Jul 2021to 30 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
- Advanced patients with unresectable lesions or lymph nodes or distant metastasis assessed by imaging;
- 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.
- They were 14-70 years old; ECoG PS score: 0-1; the expected survival time was more than 3 months;
- Within 7 days before treatment, the main organ functions met the following criteria:
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- 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.
- 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;
- 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.
Who cannot join
- 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;
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- 7) Patients with any severe and / or uncontrolled disease, including:
- Patients with poor blood pressure control (SBP ≥ 150 mmHg, DBP ≥ 100 mmHg);
- Patients with myocardial ischemia or myocardial infarction of grade I or above, arrhythmia (including QTc ≥ 480ms) and congestive heart failure (NYHA) grade ≥ 2;
- Active or uncontrolled severe infection (≥ CTC AE Level 2 infection);
- Chronic liver disease, decompensated liver disease or decompensated hepatitis;
- Renal failure needs hemodialysis or peritoneal dialysis;
- Poor control of diabetes mellitus (FBG > 10mmol / L);
- Urine routine examination showed that urine protein was ≥ + +, and 24-hour urine protein was more than 1.0 G;
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xing Zhang
Guangzhou, Guangdong, 510060
Xing Zhang
About this study
Official title: 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
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.
Read the detailed description
At present, there are a number of clinical trials of chemotherapy drugs combined with anti PD-1 antibody in the treatment of cancer, but the clinical research of chemotherapy containing adriamycin combined with anti-PD-1 antibody for advanced STS patients is almost blank. Regimen containing adriamycin is the standard chemotherapy regimen for advanced STS approved by international guidelines. As an innovative PD-1 monoclonal antibody, more phase II clinical studies are needed to evaluate the efficacy and safety of sintilimab in a variety of cancers. For patients who fail or cannot tolerate first-line treatment, treatment options are still limited. In view of the above problems, this study aims to observe and explore the efficacy and safety of chemotherapy including adriamycin combined with sintilimab versus chemotherapy in the second-line treatment of patients with advanced STS, so as to provide more and better treatment options for patients with advanced STS.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- Sintilimab plus chemotherapy, Adriamycin-based chemotherapy
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sintilimab plus chemotherapyDrug
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.
Adriamycin-based chemotherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab plus chemotherapy | Experimental | Adriamycin and ifosfamide combined with sintilimab in the treatment of advanced or unresectable soft tissue sarcoma Receives: Drug: Sintilimab plus chemotherapy; Drug: Adriamycin-based chemotherapy |
| Adriamycin-based chemotherapy | Placebo comparator | Adriamycin-based chemotherapy in the treatment of advanced or unresectable soft tissue sarcoma Receives: Drug: Sintilimab plus chemotherapy; Drug: Adriamycin-based chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate, ORR
The percentage of patients with complete remission and partial remission in patients with evaluable curative effect.
Measured: up to 24 months
Secondary outcomes (3)
Progression-free survival, PFS
PFS was defined as the time from randomization to objective tumor progression or death.
Measured: From the beginning of observation to the end of observation（1 year) of the last enrolled patient
Disease-free surviva, DFS
DFS is defined as the time from randomization to recurrence of tumor or death.
Measured: From the beginning of observation to the end of observation (1 year) of the last enrolled patient
Overall survival, OS
OS is defined as the time from randomization to death.
Measured: From the beginning of observation to the end of observation (1 year) of the last enrolled patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start26 Jul 2021
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xing Zhang, Sun Yat-sen University
- Investigators
- Xing Zhang, Principal investigator, Sun Yat-sen University CancerCenter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589754
- Sponsor's protocol ID
- Sintilimab plus chemotherapy
- Status last verified
- Dec 2023
- First submitted
- 12 Oct 2020
- Last updated
- 2 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04589754
- Acronym / sponsor ID
- Sintilimab plus chemotherapy
- Conditions
- Soft Tissue Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
At present, there are a number of clinical trials of chemotherapy drugs combined with anti PD-1 antibody in the treatment of cancer, but the clinical research of chemotherapy containing adriamycin combined with anti-PD-1 antibody for advanced STS patients is almost blank. Regimen containing adriamycin is the standard chemotherapy regimen for advanced STS approved by international guidelines. As an innovative PD-1 monoclonal antibody, more phase II clinical studies are needed to evaluate the efficacy and safety of sintilimab in a variety of cancers. For patients who fail or cannot tolerate first-line treatment, treatment options are still limited. In view of the above problems, this study aims to observe and explore the efficacy and safety of chemotherapy including adriamycin combined with sintilimab versus chemotherapy in the second-line treatment of patients with advanced STS, so as to provide more and better treatment options for patients with advanced STS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sintilimab plus chemotherapy | Experimental | Drug: Sintilimab plus chemotherapy, Drug: Adriamycin-based chemotherapyAdriamycin and ifosfamide combined with sintilimab in the treatment of advanced or unresectable soft tissue sarcoma |
| Adriamycin-based chemotherapy | Placebo comparator | Drug: Sintilimab plus chemotherapy, Drug: Adriamycin-based chemotherapyAdriamycin-based chemotherapy in the treatment of advanced or unresectable soft tissue sarcoma |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- 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;
- Advanced patients with unresectable lesions or lymph nodes or distant metastasis assessed by imaging;
- 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.
- They were 14-70 years old; ECoG PS score: 0-1; the expected survival time was more than 3 months;
Key exclusion criteria (25 listed)
- 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]);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sintilimab plus chemotherapyAI 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, Sintilimab plus chemotherapy |
| Adriamycin-based chemotherapyAI 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. | Drug | Adriamycin-based chemotherapy, Sintilimab plus chemotherapy |
Primary outcome
Overall response rate, ORR
Time frame: up to 24 months
The percentage of patients with complete remission and partial remission in patients with evaluable curative effect.
3 secondary outcomes
Progression-free survival, PFS
Time frame: From the beginning of observation to the end of observation（1 year) of the last enrolled patient
Disease-free surviva, DFS
Time frame: From the beginning of observation to the end of observation (1 year) of the last enrolled patient
Overall survival, OS
Time frame: From the beginning of observation to the end of observation (1 year) of the last enrolled patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xing Zhang principal investigator
Sun Yat-sen University CancerCenter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sintilimab plus chemotherapy and Adriamycin-based chemotherapy in people with Soft Tissue Sarcoma, run by Sun Yat-sen 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 17 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 2 Jan 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xing Zhang (020-87343383, zhangxing@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate, ORR (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2024.