OsteosarcomaPhase 2NCT07142863
Envafolimab Combined With Neoadjuvant Chemotherapy Treat Stage IIb Resectable Osteosarcoma Patients
A Phase 2 study testing Envafolimab and neoadjuvant chemotherapy in people with Osteosarcoma and Neoadjuvant Therapy, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Given that osteosarcoma typically presents at an early age and predominantly affects pediatric and adolescent populations, early control of disease progression and the opportunity for complete tumor resection are particularly crucial. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Osteosarcoma, Neoadjuvant Therapy, Neoadjuvant Chemotherapy
- What is being tested?
- Envafolimab and neoadjuvant chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2025to 30 Sep 2026
- 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 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients voluntarily participate in the study and have good compliance, signing a written informed consent form before enrollment.
- Age between 12 and 70 years, with no gender restrictions.
- Patients diagnosed with non-metastatic, resectable osteosarcoma by pathology and clinical physician assessment.
- Have measurable disease (according to RECIST 1.1 criteria, non-nodal lesions with a CT scan longest diameter ≥10 mm, and nodal lesions with a CT scan shortest diameter ≥15 mm).
- No prior systemic anti-tumor treatment.
- ECOG PS score: 0 to 1.
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- Adequate organ function:
- Hematological parameters: Absolute Neutrophil Count (ANC) ≥1.5×10^9/L, Platelet (PLT) ≥70×10^9/L, Hemoglobin (HGB) ≥90 g/L.
- Hepatic function: Total Bilirubin (TBIL) ≤1.5×Upper Limit of Normal Value (ULN); Alanine Aminotransferase (ALT) and Aspartate Transferase (AST) ≤3×ULN; Serum Albumin ≥28 g/L; Alkaline Phosphatase (ALP) ≤5×ULN; patients on routine hepatic protection treatment meeting the above criteria and stable for at least one week after investigator assessment may be included.
- Renal function: Creatinine (Cr) ≤1.5×ULN, or Creatinine clearance rate ≥50 mL/min (using the standard Cockcroft-Gault formula).
- Coagulation function: International Normalized Ratio (INR) ≤1.5, Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN; if the subject is undergoing anticoagulant therapy, PT and INR within the intended range of the anticoagulant therapy is acceptable.
Who cannot join
- Participants with a history of or concurrent diagnosis of other malignant tumors (except for cured cutaneous basal cell carcinoma and in situ cervical carcinoma).
- Patients with recurrent postoperative or previously treated osteosarcoma with local or systemic anti-tumor therapy, or with metastasis.
- Participants who have received the following treatments within 4 weeks prior to study initiation: radiation therapy for tumors, surgical procedures, chemotherapy, immunotherapy, or other investigational drugs.
- Known allergies to any component of the study medication in participants. Participants with uncontrolled clinical symptoms or diseases of the heart, such as: (1) NYHA Class II or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within the past year, (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
- Participants with active infections or fever of unknown origin >38.5°C (measured in Celsius) during the screening period or before the first dose of study medication (fever due to tumors may be included at the discretion of the investigator).
- Use of immunosuppressive drugs within 14 days prior to treatment initiation, excluding intranasal and inhaled corticosteroids or physiological doses of systemic corticosteroids (i.e., daily dose of prednisone ≤10 mg or equivalent physiological doses of other corticosteroids).
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- History of active autoimmune diseases or a history of autoimmune disorders (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary glanditis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; participants with vitiligo or asthma that may be in complete remission in childhood and currently do not require medical intervention, or history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation).
- Participants who have received live vaccines within 4 weeks prior to study medication or are likely to receive live vaccines during the study period.
- Participants with a history of substance abuse, alcoholism, or drug addiction.
- Participants deemed to be excluded from this study by the investigator, such as those with other factors that could potentially lead to premature termination of the study, such as other serious diseases (including psychiatric diseases) requiring concomitant treatment, severe laboratory abnormalities, or family or social factors that could affect participant safety, or collection of data and samples.
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
Shanghai First People's Hospital, 100 Haining Road, Hongkou District
Shanghai
About this study
Official title: Single-arm Prospective Clinical Study of PD-L1 Antibody Envafolimab Combined With Neoadjuvant Chemotherapy in Patients With Stage IIb Resectable Osteosarcoma
Given that osteosarcoma typically presents at an early age and predominantly affects pediatric and adolescent populations, early control of disease progression and the opportunity for complete tumor resection are particularly crucial. Postoperatively, patients can regain functional mobility through prosthetic implantation and artificial joint reconstruction, thereby preventing premature loss of mobility in young patients. This study aims to explore the efficacy and safety of neoadjuvant treatment with the PD-L1 antibody envafolimab in combination with standard chemotherapy in patients with resectable stage IIb osteosarcoma, and to assess whether this combined regimen can increase the proportion of patients achieving complete tumor resection.
- Being tested
- Envafolimab and neoadjuvant chemotherapy
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Envafolimab and neoadjuvant chemotherapyDrug
- PD-L1 inhibitor envafolimab Paediatric (<18 years): 2.5 mg/kg (maximum 200 mg) by subcutaneous injection on Day 1 of every week (q1w).
Adult (≥18 years): 200 mg flat dose by subcutaneous injection on Day 1 of every week (q1w).
- Neoadjuvant chemotherapy--MAP regimen (paediatric patients) Doxorubicin 75 mg/m² intravenously on Days 1-2, administered in weeks 1 and 6 of each 6-week cycle.
Cisplatin 120 mg/m² intravenously on Days 1-3, administered in weeks 1 and 6 of each 6-week cycle.
Methotrexate 8-12 g/m² intravenously on Day 1 of weeks 3 and 4 of each 6-week cycle.
- Neoadjuvant chemotherapy--DIA regimen (adult patients) Doxorubicin 75 mg/m² intravenously on Days 1-2, administered in weeks 1 and 6 of each 6-week cycle.
Cisplatin 120 mg/m² intravenously on Days 1-3, administered in weeks 1 and 6 of each 6-week cycle.
Ifosfamide 12-15 g/m² total dose intravenously on Days 1-5 of week 3 of each 6-week cycle.
| Study group | Role | What they receive |
|---|---|---|
| Envafolimab combined with neoadjuvant chemotherapy | Experimental | Not described Receives: Drug: Envafolimab and neoadjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor necrosis rate
According to the Huvos grading system, patient bone tumor specimens were evaluated and analyzed block by block in comparison with preoperative imaging data after sampling, and the data were then summarized. Tumors with necrosis rates of grade I-II were considered to have poor chemotherapeutic response (indicating poor long-term prognosis, and postoperative adjuvant chemotherapy should increase the dose intensity or modify the chemotherapy regimen), while those with necrosis rates of grade III-IV were considered to have a good chemotherapeutic response (it is recommended that postoperative adjuvant chemotherapy use the same chemotherapy regimen as preoperatively). The number of patients in each grade of tumor necrosis rate was counted, and the percentage of patients with tumor cell necrosis rate >90% (i.e., tumor necrosis rate grade III-IV) among all patients will be used as the primary outcome measure.
Measured: From enrollment to the end of surgery, about 12th weeks.
Secondary outcomes (4)
EFS (event-free survival)
The time from the start of treatment to the first occurrence of any of the following events: disease progression precluding the possibility of surgical treatment, local or distant recurrence, or death from any cause.
Measured: About 1 year.
PFS (Progression-free survival)
The time from the start of treatment to disease progression or death of the patient due to any cause.
Measured: About 1 year.
Immune Microenvironment
The immune microenvironment was assessed by single-cell RNA sequencing (scRNA-seq) of surgically resected specimens. The specific measurement is the relative abundance (percentage) of major immune-cell subsets-CD8+ T cells, CD4+ T cells, regulatory T cells (Treg), natural killer (NK) cells, M1 macrophages, and M2 macrophages-within the total viable tumor-infiltrating leukocytes (CD45+ cells) at the time of surgery. Changes in these cell-type proportions between pre-treatment biopsy and post-treatment surgical samples were computed to evaluate the impact of neoadjuvant immune therapy on the tumor microenvironment.
Measured: About 10th weeks after the start of neoadjuvant therapy (at definitive surgery).
Adverse Events (AEs)
Adverse Events (AEs) according to CTCAE v5.0
Measured: Adverse events (AEs) were recorded after enrollment and within 30 days of the last dose. Serious adverse events or adverse events related to the PD-L1 antibody envafolimab were extended to 90 days after the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start25 Aug 2025 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mengxiong Sun, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142863
- Sponsor's protocol ID
- 2024SQ009
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm Prospective Clinical Study of PD-L1 Antibody Envafolimab Combined With Neoadjuvant Chemotherapy in Patients With Stage IIb Resectable Osteosarcoma
- ClinicalTrials.gov ID
- NCT07142863
- Acronym / sponsor ID
- 2024SQ009
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 25 Aug 2025 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 27 Aug 2025 (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.
Given that osteosarcoma typically presents at an early age and predominantly affects pediatric and adolescent populations, early control of disease progression and the opportunity for complete tumor resection are particularly crucial. Postoperatively, patients can regain functional mobility through prosthetic implantation and artificial joint reconstruction, thereby preventing premature loss of mobility in young patients. This study aims to explore the efficacy and safety of neoadjuvant treatment with the PD-L1 antibody envafolimab in combination with standard chemotherapy in patients with resectable stage IIb osteosarcoma, and to assess whether this combined regimen can increase the proportion of patients achieving complete tumor resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Envafolimab combined with neoadjuvant chemotherapy | Experimental | Drug: Envafolimab and neoadjuvant chemotherapy |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Patients voluntarily participate in the study and have good compliance, signing a written informed consent form before enrollment.
- Age between 12 and 70 years, with no gender restrictions.
- Patients diagnosed with non-metastatic, resectable osteosarcoma by pathology and clinical physician assessment.
- Have measurable disease (according to RECIST 1.1 criteria, non-nodal lesions with a CT scan longest diameter ≥10 mm, and nodal lesions with a CT scan shortest diameter ≥15 mm).
- No prior systemic anti-tumor treatment.
Key exclusion criteria (10 listed)
- Participants with a history of or concurrent diagnosis of other malignant tumors (except for cured cutaneous basal cell carcinoma and in situ cervical carcinoma).
- Patients with recurrent postoperative or previously treated osteosarcoma with local or systemic anti-tumor therapy, or with metastasis.
- Participants who have received the following treatments within 4 weeks prior to study initiation: radiation therapy for tumors, surgical procedures, chemotherapy, immunotherapy, or other investigational drugs.
- Known allergies to any component of the study medication in participants. Participants with uncontrolled clinical symptoms or diseases of the heart, such as: (1) NYHA Class II or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within the past year, (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
- Participants with active infections or fever of unknown origin >38.5°C (measured in Celsius) during the screening period or before the first dose of study medication (fever due to tumors may be included at the discretion of the investigator).
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 |
|---|---|---|
| Envafolimab and neoadjuvant chemotherapy* PD-L1 inhibitor envafolimab Paediatric (<18 years): 2.5 mg/kg (maximum 200 mg) by subcutaneous injection on Day 1 of every week (q1w). Adult (≥18 years): 200 mg flat dose by subcutaneous injection on Day 1 of every week (q1w). * Neoadjuvant chemotherapy--MAP regimen (paediatric patients) Doxorubicin 75 mg/m² intravenously on Days 1-2, administered in weeks 1 and 6 of each 6-week cycle. Cisplatin 120 mg/m² intravenously on Days 1-3, administered in weeks 1 and 6 of each 6-week cycle. Methotrexate 8-12 g/m² intravenously on Day 1 of weeks 3 and 4 of each 6-week cycle. * Neoadjuvant chemotherapy--DIA regimen (adult patients) Doxorubicin 75 mg/m² intravenously on Days 1-2, administered in weeks 1 and 6 of each 6-week cycle. Cisplatin 120 mg/m² intravenously on Days 1-3, administered in weeks 1 and 6 of each 6-week cycle. Ifosfamide 12-15 g/m² total dose intravenously on Days 1-5 of week 3 of each 6-week cycle. | Drug | Envafolimab combined with neoadjuvant chemotherapy |
Primary outcome
Tumor necrosis rate
Time frame: From enrollment to the end of surgery, about 12th weeks.
According to the Huvos grading system, patient bone tumor specimens were evaluated and analyzed block by block in comparison with preoperative imaging data after sampling, and the data were then summarized. Tumors with necrosis rates of grade I-II were considered to have poor chemotherapeutic response (indicating poor long-term prognosis, and postoperative adjuvant chemotherapy should increase the dose intensity or modify the chemotherapy regimen), while those with necrosis rates of grade III-IV were considered to have a good chemotherapeutic response (it is recommended that postoperative adjuvant chemotherapy use the same chemotherapy regimen as preoperatively). The number of patients in each grade of tumor necrosis rate was counted, and the percentage of patients with tumor cell necrosis rate >90% (i.e., tumor necrosis rate grade III-IV) among all patients will be used as the primary outcome measure.
4 secondary outcomes
EFS (event-free survival)
Time frame: About 1 year.
PFS (Progression-free survival)
Time frame: About 1 year.
Immune Microenvironment
Time frame: About 10th weeks after the start of neoadjuvant therapy (at definitive surgery).
Adverse Events (AEs)
Time frame: Adverse events (AEs) were recorded after enrollment and within 30 days of the last dose. Serious adverse events or adverse events related to the PD-L1 antibody envafolimab were extended to 90 days after the end of treatment.
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 27 Aug 2025.
- Individual participant dataSharing planned: No
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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.
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 Envafolimab and neoadjuvant chemotherapy in people with Osteosarcoma and Neoadjuvant Therapy, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 11 inclusion and 10 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: opening soon, as of the sponsor's last update on 27 Aug 2025. 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?
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 Mengxiong Sun MD (+86 021 36126064, sunmengxiong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor necrosis rate (time frame: From enrollment to the end of surgery, about 12th weeks.). 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 27 Aug 2025.