Advanced or Unresectable Locally Advanced Bone and Soft Tissue SarcomaPhase 2NCT05941325
A Single-arm, Open-label, Single-center Prospective Study of Fruquintinib Combined With Envafolimab in the Treatment of Advanced or Unresectable Locally Advanced Bone and Soft Tissue Sarcoma
A Phase 2 study testing fruquintinib and Envafolimab in people with Advanced or Unresectable Locally Advanced Bone and Soft Tissue Sarcoma, run by Shanghai 6th People's Hospital at 1 site in China.
Trial summary
Many osteosarcomas are cured with a variety of combined chemotherapy and surgery, but a significant number will still relapse.VEGF promotes an immunosuppressive microenvironment and contributes to immune checkpoint inhibitor resistance in cancer.We aimed to explore the efficacy and safety of fruquintinib combined… Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Advanced or Unresectable Locally Advanced Bone and Soft Tissue Sarcoma
- What is being tested?
- fruquintinib and Envafolimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 1 Dec 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 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The subjects who volunteered to join the study signed the informed consent form, which showed good compliance and cooperated with the follow-up;
- 12-70 years old (boundary values included);
- Advanced or locally advanced bone and soft tissue sarcomas confirmed by histology or cytology, including but not limited to leiomyosarcomas, undifferentiated pleomorphic sarcomas, liposarcomas, synovial sarcomas, etc.;
- Patients with alveolar soft-tissue sarcoma, clear cell sarcoma, and other bone and soft-tissue sarcomas that progressed or recurred after at least previous anthracycline-containing chemotherapy regimens. Patients with bone and soft-tissue sarcoma who had not received previous first-line therapy were ineligible for chemotherapy or refused chemotherapy;
- At least one measurable lesion (RECIST 1.1);
- Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1 (amputation patients 0-2);
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- Life expectancy > 12 weeks；
- Hematologic examination (no blood transfusion within 14 days):
- Neutrophil absolute value ≥1.5×109/L, platelet ≥100×109/L, hemoglobin concentration ≥9g/dL;
- Liver function (aspartate aminotransferase and glutamate aminotransferase ≤2.5×ULN, bilirubin ≤1.5×ULN; AST and ALT≤5×ULN if liver metastasis is present);
- Renal function (serum creatinine ≤1.5×ULN, or creatinine clearance rate (CCr)≥60ml/min);
- Coagulation, international standardized ratio (INR) ≤1.5, prothrombin time (PT) and activated partial thrombin time (APTT) ≤1.5×ULN;
- Thyroid function, thyroid stimulating hormone (TSH) ≤ the upper normal value (ULN); If abnormal, T3 and T4 levels should be examined, and if T3 and T4 levels are normal, they can be selected;
- Women of childbearing age must have taken a serum pregnancy test negative within 7 days prior to treatment and be willing to use medically approved effective contraception (e.g., an intrauterine device, contraceptive or condom) during the study period and for 3 months after the last study drug use; For male subjects whose partner is a woman of reproductive age, surgical sterilization is required or effective contraceptive methods are recommended during the study period and for 3 months after the last study treatment;
- The parents/guardians of the young patients have the ability to understand, agree to, and sign the study informed consent (ICF) prior to initiating any program-related procedures; Subject may give consent with parental/guardian consent (if applicable).
Who cannot join
- Had received radiotherapy for cancer, surgery, chemotherapy, immunotherapy, and other investigational drugs within 4 weeks prior to treatment;
- Previous treatment with anti-PD-1 or PD-L1 combined with anti-angiogenesis TKI;
- For soft tissue sarcomas, surgical and/or radiotherapy > 5% of the bone marrow area is planned during the study period;
- Had present central nervous system (CNS) metastases or prior brain metastases；
- Use of immunosuppressive drugs within 14 days prior to initiation of treatment, excluding transnasal and inhaled corticosteroids or physiological doses of systemic steroids (i.e., prednisolone dose not exceeding 10 mg per day or the physiological equivalent of other corticosteroids);
- History of any active autoimmune disease or autoimmune disease (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with vitiligo or asthma may have complete remission in childhood and do not currently require medical intervention or history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation);
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- Severe infection (e.g., intravenous infusion of antibiotics, antifungals or antivirals) within 4 weeks prior to treatment, or unexplained fever >38.5 ℃ during screening/initial administration;
- Uncontrollable hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite optimal drug treatment);
- Significant clinical bleeding symptoms or significant bleeding tendency within 3 months prior to treatment (>30 ml within 3 months, appeared hematemesis, black dung, hematochezia) or hemoptysis (>5 mL of fresh blood within 4 weeks) , etc. Or treatment for venous/venous thrombosis events within the previous 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; Or long-term anticoagulant therapy with warfarin or heparin, or long-term antiplatelet therapy (aspirin ≥300 mg/day or clopidogrel ≥75 mg/day);
- Active heart disease, including myocardial infarction, severe/unstable angina within 6 months prior to treatment. Echocardiographic examination of left ventricular ejection fraction < 50%, poor arrhythmia control (including QTcF interval, men > 450 ms, female > 470 ms);
- Had other malignancies within the past 3 years or at the same time (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- Known to be allergic to the study drug or any of its excipients, or had severe allergic reactions to other monoclonal antibodies;
- Active or uncontrolled severe infection:
- Known human immunodeficiency virus (HIV) infection;
- A known history of clinically significant liver disease, including viral hepatitis [a known hepatitis B virus (HBV) carrier must exclude active HBV infection, i.e., positive HBV DNA (> 1×104 copies /mL or > 2000 IU/ mL);
- Known hepatitis C virus infection (HCV) with HCV RNA positive (> 1×103 copies /mL), or other hepatitis, cirrhosis];
- Have any other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions which, according to judgement of the investigator, renders the patient inappropriate for using the investigational product or affect interpretation of study results;
- Urine routine indicates urinary protein ≥ ++, and the 24-hour urine protein quantification is greater than 1.0 g.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shanghai Sixth People's Hospital
Many osteosarcomas are cured with a variety of combined chemotherapy and surgery, but a significant number will still relapse.VEGF promotes an immunosuppressive microenvironment and contributes to immune checkpoint inhibitor resistance in cancer.We aimed to explore the efficacy and safety of fruquintinib combined immunotherapy for bone and soft tissue sarcoma.
Read the detailed description
A single-arm, open-label, single-center prospective study of fruquintinib combined with envafolimab in the treatment of advanced or unresectable locally advanced bone and soft tissue sarcoma.
- Being tested
- fruquintinib, Envafolimab
- Keywords
- fruquintinib, envafolimab, advanced or unresectable locally advanced bone and soft tissue sarcoma
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fruquintinibDrug
VEGF receptor tyrosine-kinase inhibitor：Fruquintinib 4 mg orally once daily on Days 1-14 of each 21-day cycle; dose may be adjusted by the investigator within 3-7 mg. Treatment continues until disease progression, death, or intolerable toxicity.
EnvafolimabDrug
anti-PD-1 immune checkpoint inhibitor：Envafolimab（400mg), subcutaneous injection, d1, Q3w，Until disease progression or intolerable toxicity occurs.
| Study group | Role | What they receive |
|---|---|---|
| fruquintinib combined with envafolimab | Experimental | Not described Receives: Drug: fruquintinib; Drug: Envafolimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free-Survival
The time from enrollment to disease progression or death.
Measured: assessed up to 1 year
Secondary outcomes (5)
Overall Response Rate
the proportion of patients with complete response and partial response , using RECIST v 1.1
Measured: assessed up to 1 year
Disease Control Rate
the proportion of patients with complete response ，partial response and Stable Disease during or after treatment,using RECIST v 1.1
Measured: assessed up to 1 year
6-month Overall surviva
time from date of enrolment to date of death of any reason within 6 months
Measured: assessed up to 6 months
overall survival rate
time from date of enrolment to date of death of any reason.
Measured: assessed up to 2 year
Incidence of adverse events
Measured: assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start1 Apr 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Why it stopped: Recruitment is temporarily suspended to allow for operational adjustments at the study sites. The trial will resume once all site readiness requirements are met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Unresectable Locally Advanced Bone and Soft Tissue SarcomaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuier Zheng, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941325
- Sponsor's protocol ID
- 2023-025
- Status last verified
- Jun 2026
- First submitted
- 28 Jun 2023
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shanghai Sixth People's Hospital
- ClinicalTrials.gov ID
- NCT05941325
- Acronym / sponsor ID
- 2023-025
- Keywords
- fruquintinib, envafolimab, advanced or unresectable locally advanced bone and soft tissue sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Recruitment is temporarily suspended to allow for operational adjustments at the study sites. The trial will resume once all site readiness requirements are met
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 12 Jul 2023 (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.
Many osteosarcomas are cured with a variety of combined chemotherapy and surgery, but a significant number will still relapse.VEGF promotes an immunosuppressive microenvironment and contributes to immune checkpoint inhibitor resistance in cancer.We aimed to explore the efficacy and safety of fruquintinib combined immunotherapy for bone and soft tissue sarcoma.
Detailed description
A single-arm, open-label, single-center prospective study of fruquintinib combined with envafolimab in the treatment of advanced or unresectable locally advanced bone and soft tissue sarcoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fruquintinib combined with envafolimab | Experimental | Drug: fruquintinib, Drug: Envafolimab |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- The subjects who volunteered to join the study signed the informed consent form, which showed good compliance and cooperated with the follow-up;
- 12-70 years old (boundary values included);
- Advanced or locally advanced bone and soft tissue sarcomas confirmed by histology or cytology, including but not limited to leiomyosarcomas, undifferentiated pleomorphic sarcomas, liposarcomas, synovial sarcomas, etc.;
- Patients with alveolar soft-tissue sarcoma, clear cell sarcoma, and other bone and soft-tissue sarcomas that progressed or recurred after at least previous anthracycline-containing chemotherapy regimens. Patients with bone and soft-tissue sarcoma who had not received previous first-line therapy were ineligible for chemotherapy or refused chemotherapy;
- At least one measurable lesion (RECIST 1.1);
Key exclusion criteria (18 listed)
- Had received radiotherapy for cancer, surgery, chemotherapy, immunotherapy, and other investigational drugs within 4 weeks prior to treatment;
- Previous treatment with anti-PD-1 or PD-L1 combined with anti-angiogenesis TKI;
- For soft tissue sarcomas, surgical and/or radiotherapy > 5% of the bone marrow area is planned during the study period;
- Had present central nervous system (CNS) metastases or prior brain metastases；
- Use of immunosuppressive drugs within 14 days prior to initiation of treatment, excluding transnasal and inhaled corticosteroids or physiological doses of systemic steroids (i.e., prednisolone dose not exceeding 10 mg per day or the physiological equivalent of other corticosteroids);
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 |
|---|---|---|
| fruquintinibVEGF receptor tyrosine-kinase inhibitor：Fruquintinib 4 mg orally once daily on Days 1-14 of each 21-day cycle; dose may be adjusted by the investigator within 3-7 mg. Treatment continues until disease progression, death, or intolerable toxicity. | Drug | fruquintinib combined with envafolimab |
| Envafolimabanti-PD-1 immune checkpoint inhibitor：Envafolimab（400mg), subcutaneous injection, d1, Q3w，Until disease progression or intolerable toxicity occurs. | Drug | fruquintinib combined with envafolimab |
Primary outcome
Progression-Free-Survival
Time frame: assessed up to 1 year
The time from enrollment to disease progression or death.
5 secondary outcomes
Overall Response Rate
Time frame: assessed up to 1 year
Disease Control Rate
Time frame: assessed up to 1 year
6-month Overall surviva
Time frame: assessed up to 6 months
overall survival rate
Time frame: assessed up to 2 year
Incidence of adverse events
Time frame: assessed up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 fruquintinib and Envafolimab in people with Advanced or Unresectable Locally Advanced Bone and Soft Tissue Sarcoma, run by Shanghai 6th People's Hospital 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 15 inclusion and 18 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: paused, as of the sponsor's last update on 5 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free-Survival (time frame: assessed up to 1 year). 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 5 Jun 2026.