Soft Tissue SarcomaPhase 2NCT04589741
Toripalimab Combined With CAV/IE Regimen
A Phase 2 study testing Toripalimab Combined With CAV/IE chemotherapy and CAV/IE alternate 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 investigate the efficacy and safety of CAV/IE chemotherapy combined with toripalimab versus CAV/IE chemotherapy alone in the treatment of patients with advanced or unresectable bone and soft tissue sarcomas who failed in standard treatment. 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?
- Toripalimab Combined With CAV/IE chemotherapy and CAV/IE alternate chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2020to 30 Jun 2027
- Phase
- Phase 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 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;
- For all advanced or non resectable bone and soft tissue sarcomas confirmed by pathology, the standard treatment failed or there was no standard treatment. They were mainly synovial sarcoma, leiomyosarcoma, undifferentiated pleomorphic sarcoma, liposarcoma, fibrosarcoma, clear cell sarcoma, angiosarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumor, undiffertiated sarcoma, bone sarcoma, chondrosarcoma, Ewing's sarcoma, rhabdomyosarcoma, dermatofibrosarcoma protuberans, myofibroblastic sarcoma, malignant solitary fibroma, postradiation sarcoma,etc. But the pathological subtypes without standard treatment can be treated as first-line treatment, including but not limited to radiation-induced sarcoma, dedifferentiated / pleomorphic liposarcoma, clear cell sarcoma, etc., except for the following types: well differentiated liposarcoma, 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:
- Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN);
- Alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5uln; ALT and AST ≤ 5uln with liver metastasis
- 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%).
- 6)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) 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 was performed within 4 weeks before admission or limited field radiotherapy was performed within 2 weeks before grouping;
- 4) 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]);
- 5) Any unrelieved toxic reaction higher than CTC AE (4.01) grade 1 or above caused by previous treatment, excluding alopecia;
- 6) Patients with any severe and / or uncontrolled disease, including:
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- 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;
- 7) Major surgical treatment, open biopsy or obvious traumatic injury were performed within 28 days before admission;
- 8) 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;
- 9) Patients who had AVT events within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism;
- 10) There were active ulcer, intestinal perforation and intestinal obstruction;
- 11) 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;
- 12) 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;
- 13) 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);
- 14) The subjects had active tuberculosis;
- 15) 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;
- 16) 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. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Xing Zhang, zhangxing@sysucc.org.cn
About this study
Official title: A Multicenter, Randomized, Parallel-controlled Phase II Study of Toripalimab Combined With CAV/IE Regimen Versus Chemotherapy Alone in Patients With Advanced or Unresectable Bone and Soft Tissue Sarcoma Who Have Failed Standard Treatment
The aim of this study was to investigate the efficacy and safety of CAV/IE chemotherapy combined with toripalimab versus CAV/IE chemotherapy alone in the treatment of patients with advanced or unresectable bone and soft tissue sarcomas who failed in standard treatment.
Read the detailed description
At present, there are many clinical trials of chemotherapy drugs combined with anti-PD-1 antibody in the treatment of tumor, but the clinical study of CAV/IE chemotherapy combined with anti-PD-1 antibody in the treatment of advanced or non resectable bone and soft tissue sarcoma has not been started, and the related research is still in the blank state. In view of the above problems, to observe and evaluate the efficacy and safety of CAV/IE chemotherapy combined with toripalimab versus CAV/IE chemotherapy alone in the treatment of advanced or non resectable bone and soft tissue sarcoma patients, so as to provide more treatment options for patients with advanced or non resectable bone and soft tissue sarcoma.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- Toripalimab Combined With CAV/IE chemotherapy, CAV/IE alternate chemotherapy
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toripalimab Combined With CAV/IE chemotherapyDrug
CAV/IE regimen alternate chemotherapy (regimen 1: CTX 1.2mg/m2 D1 + ADM 50mg/m2 D1 + VCR 1.4mg/m2 D1 and scheme 2: IFO 1.5g/m2 D1-5 + vp-16 90mg / m2 D1-5, IV drip). Regimen 1 and 2 were performed alternately, with a cycle of 3 weeks; The patients were treated with toripalimab (240mg, 6ml) intravenously every 3 weeks; If doxorubicin has reached the upper limit or reduced cardiac toxicity, liposome adriamycin (50mg/m2) or IE regimen can be used For all subjects with disease control (CR+PR+SD), a maximum of 8-10 cycles of treatment is allowed. If doxorubicin reaches the upper limit or to reduce cardiotoxicity, liposomal doxorubicin (35 mg/m² for age ≥60; 40 mg/m² for age <60) or the IE regimen may be used as an alternative.
After completing 8-10 cycles, treatment group subjects with disease control may undergo 1:1 randomization to toripalimab 240 mg IV maintenance or discontinuing treatment until progression or intolerance.
CAV/IE alternate chemotherapyDrug
CAV/IE alternate chemotherapy (regimen1: CTX 1.2mg/m2 D1 + ADM 50mg/m2 D1 + VCR 1.4mg/m2 D1 and regimen2: IFO 1.5g/m2 D1-5 + VP-16 90mg/m2 D1-5, IV drip), regimen 1 and 2 were performed alternately, with a cycle of 3 weeks.
Patiens with disease control (CR+PR+SD) and tolerable adverse reactions were treated continuously with a maximum of 8-10 cycles. If doxorubicin has reached the upper limit or reduced cardiac toxicity, liposome adriamycin (≥ 60 years old: 35mg/m2, < 60 year old: 40mg/m2) or IE regimen can be used. The study was completed when the researchers considered that the patients were not suitable for continuous medication or the efficacy evaluation was disease progression (PD). No other anti-tumor treatment can be carried out during the treatment.
| Study group | Role | What they receive |
|---|---|---|
| toripalimab combined with CAV/IE regimen | Experimental | toripalimab combined with CAV/IE regimen in patients with advanced or unresectable bone and soft tissue sarcomas who failed standard treatment Receives: Drug: Toripalimab Combined With CAV/IE chemotherapy |
| CAV/IE chemotherapy alone | Placebo comparator | CAV/IE chemotherapy alone in patients with advanced or unresectable bone and soft tissue sarcomas who failed standard treatment Receives: Drug: CAV/IE alternate chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival, PFS
PFS was defined as the time from randomization to objective tumor progression or death.
Measured: Up to 24 months
Secondary outcomes (4)
Overall response rate, ORR
The proportion of patients with complete response and partial response.
Measured: up to 24 months
DCR, disease control rate
The proportion of patients with complete response, partial response and stable disease.
Measured: Up to 24 months
Overall survival, OS
OS is defined as the time from randomization to death.
Measured: Up to 24 months
Adverse event
Safety, any AE or SAE
Measured: up to 24 months
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 start23 Oct 2020
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jun 2027 (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
- 134 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 Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589741
- Sponsor's protocol ID
- Toripalimab plus chemotherapy
- Status last verified
- Jun 2026
- First submitted
- 12 Oct 2020
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Parallel-controlled Phase II Study of Toripalimab Combined With CAV/IE Regimen Versus Chemotherapy Alone in Patients With Advanced or Unresectable Bone and Soft Tissue Sarcoma Who Have Failed Standard Treatment
- ClinicalTrials.gov ID
- NCT04589741
- Acronym / sponsor ID
- Toripalimab plus chemotherapy
- Conditions
- Soft Tissue Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 23 Oct 2020 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jun 2027 (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 investigate the efficacy and safety of CAV/IE chemotherapy combined with toripalimab versus CAV/IE chemotherapy alone in the treatment of patients with advanced or unresectable bone and soft tissue sarcomas who failed in standard treatment.
Detailed description
At present, there are many clinical trials of chemotherapy drugs combined with anti-PD-1 antibody in the treatment of tumor, but the clinical study of CAV/IE chemotherapy combined with anti-PD-1 antibody in the treatment of advanced or non resectable bone and soft tissue sarcoma has not been started, and the related research is still in the blank state. In view of the above problems, to observe and evaluate the efficacy and safety of CAV/IE chemotherapy combined with toripalimab versus CAV/IE chemotherapy alone in the treatment of advanced or non resectable bone and soft tissue sarcoma patients, so as to provide more treatment options for patients with advanced or non resectable bone and soft tissue sarcoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| toripalimab combined with CAV/IE regimen | Experimental | Drug: Toripalimab Combined With CAV/IE chemotherapytoripalimab combined with CAV/IE regimen in patients with advanced or unresectable bone and soft tissue sarcomas who failed standard treatment |
| CAV/IE chemotherapy alone | Placebo comparator | Drug: CAV/IE alternate chemotherapyCAV/IE chemotherapy alone in patients with advanced or unresectable bone and soft tissue sarcomas who failed standard treatment |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Patients voluntarily participated in the study and signed informed consent;
- For all advanced or non resectable bone and soft tissue sarcomas confirmed by pathology, the standard treatment failed or there was no standard treatment. They were mainly synovial sarcoma, leiomyosarcoma, undifferentiated pleomorphic sarcoma, liposarcoma, fibrosarcoma, clear cell sarcoma, angiosarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumor, undiffertiated sarcoma, bone sarcoma, chondrosarcoma, Ewing's sarcoma, rhabdomyosarcoma, dermatofibrosarcoma protuberans, myofibroblastic sarcoma, malignant solitary fibroma, postradiation sarcoma,etc. But the pathological subtypes without standard treatment can be treated as first-line treatment, including but not limited to radiation-induced sarcoma, dedifferentiated / pleomorphic liposarcoma, clear cell sarcoma, etc., except for the following types: well differentiated liposarcoma, 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 (24 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) 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 was performed within 4 weeks before admission or limited field radiotherapy was performed within 2 weeks before grouping;
- 4) 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]);
- 5) Any unrelieved toxic reaction higher than CTC AE (4.01) grade 1 or above caused by previous treatment, excluding alopecia;
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 |
|---|---|---|
| Toripalimab Combined With CAV/IE chemotherapyCAV/IE regimen alternate chemotherapy (regimen 1: CTX 1.2mg/m2 D1 + ADM 50mg/m2 D1 + VCR 1.4mg/m2 D1 and scheme 2: IFO 1.5g/m2 D1-5 + vp-16 90mg / m2 D1-5, IV drip). Regimen 1 and 2 were performed alternately, with a cycle of 3 weeks; The patients were treated with toripalimab (240mg, 6ml) intravenously every 3 weeks; If doxorubicin has reached the upper limit or reduced cardiac toxicity, liposome adriamycin (50mg/m2) or IE regimen can be used For all subjects with disease control (CR+PR+SD), a maximum of 8-10 cycles of treatment is allowed. If doxorubicin reaches the upper limit or to reduce cardiotoxicity, liposomal doxorubicin (35 mg/m² for age ≥60; 40 mg/m² for age <60) or the IE regimen may be used as an alternative. After completing 8-10 cycles, treatment group subjects with disease control may undergo 1:1 randomization to toripalimab 240 mg IV maintenance or discontinuing treatment until progression or intolerance. | Drug | toripalimab combined with CAV/IE regimen |
| CAV/IE alternate chemotherapyCAV/IE alternate chemotherapy (regimen1: CTX 1.2mg/m2 D1 + ADM 50mg/m2 D1 + VCR 1.4mg/m2 D1 and regimen2: IFO 1.5g/m2 D1-5 + VP-16 90mg/m2 D1-5, IV drip), regimen 1 and 2 were performed alternately, with a cycle of 3 weeks. Patiens with disease control (CR+PR+SD) and tolerable adverse reactions were treated continuously with a maximum of 8-10 cycles. If doxorubicin has reached the upper limit or reduced cardiac toxicity, liposome adriamycin (≥ 60 years old: 35mg/m2, < 60 year old: 40mg/m2) or IE regimen can be used. The study was completed when the researchers considered that the patients were not suitable for continuous medication or the efficacy evaluation was disease progression (PD). No other anti-tumor treatment can be carried out during the treatment. | Drug | CAV/IE chemotherapy alone |
Primary outcome
Progression-free survival, PFS
Time frame: Up to 24 months
PFS was defined as the time from randomization to objective tumor progression or death.
4 secondary outcomes
Overall response rate, ORR
Time frame: up to 24 months
DCR, disease control rate
Time frame: Up to 24 months
Overall survival, OS
Time frame: Up to 24 months
Adverse event
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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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.
Xing Zhang principal investigator
Sun Yat-Sen University Cancer Center
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 Toripalimab Combined With CAV/IE chemotherapy and CAV/IE alternate 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 16 inclusion and 24 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 12 Jun 2026. 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?
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 Xing Zhang (02087343383, zhangxing@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival, PFS (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 12 Jun 2026.