Soft Tissue SarcomaPhase 2NCT05926700
Efficacy and Safety of Cadonilimab Plus Anlotinib in Advanced STS That Failed the Previous First-line Standard Treatment
A Phase 2 study testing Candonilimab in people with Soft Tissue Sarcoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Objective to evaluate the efficacy and safety of candonilimab combined with anlotinib in the treatment of progressive or metastatic soft tissue sarcoma that failed previous first-line standard therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- Candonilimab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2024to 1 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged ≥18 years .
- Voluntarily sign written informed consent.
- Advanced or unresectable soft tissue sarcomas confirmed by pathology mainly include liposarcoma, leiomyosarcoma, synovial sarcoma, undifferentiated pleomorphic sarcoma / malignant fibrous histiocytoma, fibrosarcoma, pleomorphic rhabdomyosarcoma, acinar soft tissue sarcoma, clear cell sarcoma, angiosarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumor, undifferentiated sarcoma, sarcoma after radiotherapy, etc.
- Patients who have used at least one chemotherapy regimen (including anthracyclines) in the past (except for acinar soft tissue sarcoma and clear cell sarcoma) and are evaluated as disease progression according to the efficacy evaluation criteria of solid tumors within 6 months.
- According to RECIST 1.1, there was at least one measurable tumor lesion.
- ECoG score 0 or 1.
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- The expected survival was ≥ 3 months.
- The main organs function well:
- Hematology (no blood components and cell growth factors were used to support treatment within 7 days before starting the study treatment):
- The absolute value of neutrophils ANC ≥ 1.5 × 109/l (1500/mm3).
- Ii Platelet count ≥ 100 × 109/l (100000/mm3).
- hemoglobin ≥ 90 g/l.
- Kidney:
- Creatinine clearance * (CrCl) calculated value ≥ 50 ml/min.
- The Cockcroft Gault formula will be used to calculate CrCl (Cockcroft Gault formula)
- CrCl (ml/min) = [(140 - age) × Weight (kg) × F] / (SCR (mg/dl) × 72)
- Among them, f=1 for men and f=0.85 for women; SCR = serum creatinine.
- Ii Urine protein < 2+ or 24-hour (H) urine protein quantification <1.0 G.
- Liver:
- Total serum bilirubin (TBIL) ≤ 1.5 × ULN.
- AST and alt ≤ 2.5 × ULN.
- for subjects with liver metastasis, serum total bilirubin (TBIL) ≤ 3 × ULN; ALT and AST ≤ 5 × ULN;
- Coagulation function:
- International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
- Female subjects with fertility must have a serum pregnancy test within 3 days before the first medication and the result is negative. If a female issue with fertility has sex with a male partner who has not been sterilized, the subject must take an acceptable contraceptive method since the screening, and must agree to continue using the contraceptive method within 6 months after the last administration of the study drug; Whether to stop contraception after this time point should be discussed with the investigator.
- The subject is willing and able to comply with the visit, treatment plan, laboratory test, and other study requirements as stipulated in the schedule.
Who cannot join
- Participated in the treatment of experimental drugs or used experimental devices within 4 weeks before the first administration of candonilimab.
- Had other active malignancies within 3 years before enrollment. Except for locally curable malignant tumors (manifested as cured), such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, endometrial, cervical or breast cancer in situ.
- Another clinical study is enrolled at the same time, unless it is an observational (non interventional) clinical study or the follow-up period of an interventional study (defined as the time from the first medication to the last medication of the previous clinical study is more than 4 weeks or the five half lives of the study drug are more than 5, whichever is the longest).
- Active autoimmune diseases requiring systemic treatment within two years before the start of study treatment, or autoimmune diseases that may recur or are planned to be treated according to the judgment of the investigator; The following exceptions: skin diseases that do not need systematic treatment (such as vitiligo, alopecia, psoriasis or eczema); Hypothyroidism caused by autoimmune thyroiditis only requires a stable dose of hormone replacement therapy; Well controlled type I diabetes; Subjects whose asthma in childhood has been completely relieved and who do not need any intervention after adulthood; The investigator judged that the disease would not recur without external triggers.
- Inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea) with active or requiring clinical treatment.
- The subject required systemic treatment with corticosteroids (>10mg daily prednisone equivalent) or other immunosuppressive drugs within 14 days after taking the study drug. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal gland replacement doses of >10mg daily prednisone equivalent were allowed. Subjects were allowed to use topical, ocular, intra-articular, intranasal, and inhaled corticosteroids (with minimal systemic absorption). Physiological alternative doses of systemic corticosteroids are allowed, even if >10 mg / day of prednisone equivalent. Short term use of corticosteroids is allowed to prevent (such as contrast allergy) or treat non autoimmune diseases (such as delayed type hypersensitivity caused by contact allergens).
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- He has previously received immune checkpoint inhibitors (such as anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.), immune checkpoint agonists (such as antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.), immune cell therapy and other treatments targeting tumor immune mechanism.
- The best swelling evaluation result of patients who had received previous treatment with anlotinib was PD, or SD ≤ 12 weeks.
- History of a known positive test for human immunodeficiency virus or known acquired immune deficiency syndrome.
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- Known presence or history of interstitial lung disease.
- Necrotic lesions were found within 4 weeks before the subjects were enrolled, and the investigator judged that there was a risk of major bleeding.
- Serious infections occurred within 4 weeks before the first administration, including but not limited to complications requiring hospitalization, sepsis or severe pneumonia.
- Known to have active pulmonary tuberculosis (TB). Subjects suspected of active TB should be examined by chest X-ray, sputum and excluded by clinical symptoms and signs.
- Untreated patients with chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA > 1000iu/ml, and patients with active hepatitis C should be excluded. Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B patients (HBV dna<1000iu/ml), and cured hepatitis C patients can be enrolled. For HCV AB positive subjects, they are eligible to participate in the study only if HCV RNA test results are negative.
- Received the last radiotherapy or anti-tumor treatment (chemotherapy, targeted therapy, Chinese herbal medicine used to control tumor disease or tumor embolization, etc.) within 4 weeks before the first administration of candonilimab.
- Major surgical procedures were performed within 30 days before the first dose of candonilimab or had not yet fully recovered from previous surgery. Local surgery (such as systemic port placement, core needle biopsy, and prostate biopsy) was allowed, provided that the surgery was completed at least 24 hours before the first administration of the study treatment drug.
- Meningeal metastasis, spinal cord compression, leptomeningeal disease, or active brain metastasis are known. However, subjects who meet the following requirements and have measurable lesions outside the central nervous system are allowed to be enrolled: 1) they have not been treated before and are currently asymptomatic (such as no neurological dysfunction, epilepsy or other typical symptoms and signs of central nervous system metastasis; no glucocorticoid treatment is required); 2) After treatment, the patient was asymptomatic, and the imaging was stable for at least 4 weeks before the start of study treatment (if there were no new or expanded brain metastases), and the treatment of systemic glucocorticoids and anticonvulsants had been stopped for at least 2 weeks.
- According to the judgment of the investigator, subjects with pleural effusion, pericardial effusion or ascites that cannot be stably controlled by repeated drainage or other methods.
- Uncontrolled concurrent diseases, including symptomatic congestive heart failure (grade 3 or 4 according to the New York Heart Association functional classification), uncontrolled hypertension, unstable angina, poorly controlled arrhythmia, evidence of acute or ongoing myocardial ischemia, severe active peptic ulcer disease or gastritis, Or mental illness / social condition that will restrict subjects' compliance with research requirements or affect subjects' ability to provide written informed consent. Any arterial thromboembolic event occurred within 6 months before enrollment, including myocardial infarction, cerebrovascular accident or transient ischemic attack, with a history of deep vein thrombosis, pulmonary embolism or any other serious thromboembolism.
- the toxicity of previous anti-tumor treatment was not relieved, which was defined as the toxicity did not return to grade 0 or 1 of NCI CTCAE version 5.0, or the level specified in the inclusion / exclusion criteria, except for hair loss. Subjects who have irreversible toxicity and are not expected to aggravate after the administration of study drugs (such as hearing loss) may be included in the study after consultation with the medical inspector. Subjects with long-term toxicity caused by radiotherapy who cannot recover according to the judgment of the investigator may be included in the study after consultation with the medical inspector.
- received a live vaccine within 30 days before the first dose of candonilimab or planned to receive a live vaccine during the study period.
- known history of severe hypersensitivity to other monoclonal antibodies.
- are known to be allergic to any of the components of the candonilimab formulation.
- pregnant or lactating women.
- any condition that the investigator believes may lead to the risk of receiving study drug treatment, or will interfere with the evaluation of study drug or the safety of subjects or the analysis of study results.
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
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Ying Dong
About this study
Official title: Efficacy and Safety of Cadonilimab Combined With Anlotinibin in the Treatment of Advanced or Metastatic Soft Tissue Sarcoma With Previous First-Line Standard Treatment Failure.
Objective to evaluate the efficacy and safety of candonilimab combined with anlotinib in the treatment of progressive or metastatic soft tissue sarcoma that failed previous first-line standard therapy.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- Candonilimab
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CandonilimabDrug
The patients were treated with Candonilimab + anlotinib, with Cadonilimab 10mg/kg, D1 administration; Anlotinib 12mg/ day was orally administered for 2 weeks and stopped for a week, with 21 days as a course of treatment.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | The subject will be treated with Candonilimab + anlotinib every 21 days as a treatment cycle: Candonilimab 10mg/kg, D1 administration; Anlotinib 12mg/ day was taken orally for 2 weeks and stopped for a week. Until the subject has disease progression, intolerable toxicity, and the investigator's decision, the subject withdraws informed consent, death or other reasons specified in the protocol. Receives: Drug: Candonilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free-Survival （PFS）
Time from randomization to disease progression
Measured: through study completion，an average of 1 year
Secondary outcomes (6)
Overall survival （OS）
The overall survival time of tumor patients
Measured: through study completion，an average of 1 year
objective response rate (ORR)
The proportion of patients whose tumor volume reduced by 30% and could maintain for more than 4 weeks, that is, the sum of the proportion of complete remission (CR) and partial remission (PR)
Measured: through study completion，an average of 1 year
disease control rate （DCR)
The percentage of disease remission (including complete remission and partial remission, pr+cr) and stable disease (SD) in the number of evaluable cases after treatment
Measured: through study completion，an average of 1 year
time-to-response (TTR)
It refers to the overall time from the time of tumor occurrence to the patient's death
Measured: through study completion，an average of 1 year
Duration of Response(DOR)
Remission duration refers to the time from the first CR or PR to disease progression.
Measured: through study completion，an average of 1 year
Adverse events
The incidence and severity of adverse events (AES) and clinically significant abnormal laboratory test results.
Measured: through study completion，an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start28 Feb 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Mar 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 Second Affiliated Hospital, Zhejiang 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
- 27 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Dong, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926700
- Sponsor's protocol ID
- 2023-0454
- Status last verified
- Dec 2025
- First submitted
- 22 Jun 2023
- Last updated
- 8 Apr 2026
- 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 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Cadonilimab Combined With Anlotinibin in the Treatment of Advanced or Metastatic Soft Tissue Sarcoma With Previous First-Line Standard Treatment Failure.
- ClinicalTrials.gov ID
- NCT05926700
- Acronym / sponsor ID
- 2023-0454
- Conditions
- Soft Tissue Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 3 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.
Objective to evaluate the efficacy and safety of candonilimab combined with anlotinib in the treatment of progressive or metastatic soft tissue sarcoma that failed previous first-line standard therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Drug: CandonilimabThe subject will be treated with Candonilimab + anlotinib every 21 days as a treatment cycle: Candonilimab 10mg/kg, D1 administration; Anlotinib 12mg/ day was taken orally for 2 weeks and stopped for a week. Until the subject has disease progression, intolerable toxicity, and the investigator's decision, the subject withdraws informed consent, death or other reasons specified in the protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Male or female, aged ≥18 years .
- Voluntarily sign written informed consent.
- Advanced or unresectable soft tissue sarcomas confirmed by pathology mainly include liposarcoma, leiomyosarcoma, synovial sarcoma, undifferentiated pleomorphic sarcoma / malignant fibrous histiocytoma, fibrosarcoma, pleomorphic rhabdomyosarcoma, acinar soft tissue sarcoma, clear cell sarcoma, angiosarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumor, undifferentiated sarcoma, sarcoma after radiotherapy, etc.
- Patients who have used at least one chemotherapy regimen (including anthracyclines) in the past (except for acinar soft tissue sarcoma and clear cell sarcoma) and are evaluated as disease progression according to the efficacy evaluation criteria of solid tumors within 6 months.
- According to RECIST 1.1, there was at least one measurable tumor lesion.
Key exclusion criteria (26 listed)
- Participated in the treatment of experimental drugs or used experimental devices within 4 weeks before the first administration of candonilimab.
- Had other active malignancies within 3 years before enrollment. Except for locally curable malignant tumors (manifested as cured), such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, endometrial, cervical or breast cancer in situ.
- Another clinical study is enrolled at the same time, unless it is an observational (non interventional) clinical study or the follow-up period of an interventional study (defined as the time from the first medication to the last medication of the previous clinical study is more than 4 weeks or the five half lives of the study drug are more than 5, whichever is the longest).
- Active autoimmune diseases requiring systemic treatment within two years before the start of study treatment, or autoimmune diseases that may recur or are planned to be treated according to the judgment of the investigator; The following exceptions: skin diseases that do not need systematic treatment (such as vitiligo, alopecia, psoriasis or eczema); Hypothyroidism caused by autoimmune thyroiditis only requires a stable dose of hormone replacement therapy; Well controlled type I diabetes; Subjects whose asthma in childhood has been completely relieved and who do not need any intervention after adulthood; The investigator judged that the disease would not recur without external triggers.
- Inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea) with active or requiring clinical treatment.
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 |
|---|---|---|
| CandonilimabThe patients were treated with Candonilimab + anlotinib, with Cadonilimab 10mg/kg, D1 administration; Anlotinib 12mg/ day was orally administered for 2 weeks and stopped for a week, with 21 days as a course of treatment. | Drug | intervention group |
Primary outcome
Progression-Free-Survival （PFS）
Time frame: through study completion，an average of 1 year
Time from randomization to disease progression
6 secondary outcomes
Overall survival （OS）
Time frame: through study completion，an average of 1 year
objective response rate (ORR)
Time frame: through study completion，an average of 1 year
disease control rate （DCR)
Time frame: through study completion，an average of 1 year
time-to-response (TTR)
Time frame: through study completion，an average of 1 year
Duration of Response(DOR)
Time frame: through study completion，an average of 1 year
Adverse events
Time frame: through study completion，an average of 1 year
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 8 Apr 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.
Ying Dong study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
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 Candonilimab in people with Soft Tissue Sarcoma, run by Second Affiliated Hospital, Zhejiang 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 26 inclusion and 26 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 8 Apr 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?
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 Ying Dong (13666669105, dongying74@zju.edu.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: through study completion，an average of 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 8 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.