ChondrosarcomaPhase 2NCT05193188

A Study of Anlotinib Combined With or Without PD-1 Antibody on Unresectable High-grade Chondrosarcoma

A Phase 2 study testing Anlotinib hydrochloride and PD-1 inhibitor in people with Chondrosarcoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Chondrosarcoma
What is being tested?: Anlotinib hydrochloride and PD-1 inhibitor
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteChina
Study dates: 6 Feb 2023to 31 Mar 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 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Age ≥18 years old, no gender limit; 2. ECOG PS score 0-2 points; 3. unresectable locally advanced or metastatic chondrosarcoma confirmed by histopathology, including high-grade (grade II-III) conventional CS and dedifferentiated CS; 4. Allow previous surgery, radiotherapy, or chemotherapy therapies; 5. Have at least 1 measurable lesion in accordance with the RECIST1.1; 6. The main organs are functioning normally and meet the following criteria within 7 days before treatment:
The standard of routine blood examination must be met (no blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors):
Hemoglobin (HB) ≥90g/L;
The absolute value of neutrophils (ANC) ≥ 1.5×109/L;
Platelets (PLT) ≥100×109/L ② The biochemical inspection shall meet the following standards:

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Total bilirubin (TBIL)≤1.5×upper limit of normal (ULN);
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN, if there is liver metastasis, ALT and AST ≤ 5×ULN;
Serum creatinine (Cr)≤1.5×ULN or creatinine clearance (CCr)≥60ml/min;
③ Urine protein <2+, and 24h urine protein quantitatively shows that the protein must be ≤ 1g;
④ Coagulation function: INR <2.0 and APTT≤1.5×ULN
⑤ Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ lower limit of normal value (60%)
⑥ Thyroid function: TSH ≤ upper limit of normal (ULN); if abnormal, T3 and T4 levels should be considered, and T3 and T4 levels are normal and can be included in the group; 9. The fertile male or female agrees to use reliable contraceptive methods during treatment and at least 12 months after the last study drug is taken; 10. Sign the informed consent form with my consent, have good compliance and cooperate with follow-up.

Who cannot join

1. Received anti-CTLA-4/PD-1/PD-L1 antibody treatment previously ; 2. Received anti-angiogenic TKI drugs (such as Anlotinib, Apatinib, Regofenib, etc.) or anti-angiogenic antibody drugs (such as Bevacizumab) previously; 3. Received other anti-tumor treatments within 4 weeks before enrollment, including systemic therapy, radiotherapy, major surgery, open biopsy, or participated in other clinical trials; 4. Patients who have not recovered from adverse events caused by any previous treatment to NCI-CTCAE (5.0) ≤1, excluding hair loss; 5. The investigator determines that there is a significant risk of bleeding, including but not limited to:
Imaging shows that the tumor has invaded important blood vessels or it is judged by the investigator that the tumor is likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study, or accompanied by large veins (iliac blood vessels, inferior vena cava, pulmonary vein, superior vena cava) tumor thrombus formation, or a history of aneurysm and the possibility of rupture;
Received major surgical operations or had obvious traumatic injuries within 4 weeks before enrollment, or had any bleeding or bleeding event ≥ NCI-CTCAE Grade 3, or had any unhealed wounds, ulcers or fractures;
There is a tendency for hereditary or acquired bleeding and thrombosis, such as hemophilia patients, blood coagulation dysfunction, thrombocytopenia, hypersplenism, etc.;
Abnormal coagulation function (INR>1.5 or prothrombin time (PT)>ULN+4 seconds or APTT>1.5 ULN), have bleeding tendency, or are receiving thrombolytic or anticoagulant therapy;
Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or similar drugs; Note: Under the premise that the international normalized ratio of prothrombin time (INR) ≤ 1.5, the use of low-dose heparin (daily dosage for adults is 6,000 to 12,000 U) or low-dose aspirin (daily dosage ≤100 mg); 6. The following symptoms or comorbidities exist:

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A history of hypertension, and can not be well controlled after treatment with 1-2 kinds of antihypertensive drugs (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg);
Poorly controlled diabetes (fasting blood glucose> 10mmol/L);
Significant cardiovascular damage includes, but is not limited to: unstable angina, myocardial ischemia or myocardial infarction, grade ≥2 congestive heart failure (New York Heart Association (NYHA) classification); occurred within 6 months Arterial/venous thrombotic events, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism;
Sinus bradycardia of grade I or higher; or atrioventricular block of second degree or higher, or sinus arrest (except for pacemaker); arrhythmia (including QTc ≥480ms); need to take it at the same time to prolong the QTc interval Period drug
Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral treatment;
Urine routine test shows urine protein ≥ ++, and the 24-hour urine protein quantitative is confirmed to be> 1.0 g;
Renal failure requires hemodialysis or peritoneal dialysis;
A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation, hematopoietic stem cell transplantation, or receiving systemic corticosteroids within 2 weeks before enrollment Or any other form of immunosuppressive therapy; Note: In the absence of active autoimmune diseases, inhaled or topical steroids and adrenal corticosteroids with a dose of> 10 mg/day prednisone equivalent dose are allowed, and the use of no more than 10 mg/day prednisone curative dose is allowed Adrenal corticosteroid replacement therapy, allowing glucocorticoids to be used as a preventive drug for hypersensitivity reactions (such as pre-docetaxel prophylaxis);
Active or uncontrolled serious infection (≥CTC AE grade 2 infection) occurred within 4 weeks before enrollment;
Judging by imaging studies, there is a central nervous system metastasis;
Suffered from other malignant tumors in the past 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, skin squamous cell carcinoma, and superficial bladder tumors;
Those who have a history of psychotropic drug abuse and cannot be quit or have mental disorders;
Those who have received ascites or pleural effusion drainage within 2 months of enrollment, or those who have uncontrollable pericardial effusion, pleural effusion and ascites;
Complications of pulmonary fibrosis or interstitial pneumonia, or severe chronic obstructive pulmonary disease;
Severe gastrointestinal diseases, such as gastric perforation, active peptic ulcer, etc.; 8. Combined medication
During the study period, strong CYP3A inhibitors (such as itraconazole, telithromycin, clarithromycin, ritonavir, etc.) or moderate CYP3A inhibitors (such as ciprofloxacin) should be used;
During the study period, strong CYP3A inducers (such as phenobarbital, phenytoin, rifampicin, carbamazepine) or moderate CYP3A inducers should be used;
During the study period, it is necessary to take traditional Chinese medicines, especially those with anti-tumor activity; 9. Other
It is expected that any form of systemic or local anti-tumor therapy will be taken during the study period;
As judged by the investigator, there is a serious hazard to patient safety, concomitant diseases that may confuse the results of the study, or affect the patient to complete the study or any other conditions, such as a history of gastrointestinal disease that may affect the absorption of oral drugs.
Those who have multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
Allergic to the drugs in this study;
Live vaccines have been vaccinated within 30 days before enrollment. Live vaccines include but are not limited to the following vaccines: measles, mumps, rubella, varicella/shingles (chickenpox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), typhoid vaccine.

Trial locations and contacts

1 site in 1 country.

Zhaoming Ye, Medical PhD contact

86-0571-87783777

yezhaoming@zju.edu.cn

China1 site, 1 recruiting

The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Zhaoming Ye, M.D., 0086 13606501549, yezhaoming@zju.edu.cn
Recruiting

Other trials in China

About this study

Official title: A Multicenter Clinical Controlled Study of Anlotinib Combined With PD-1 Antibody on Unresectable High-grade Chondrosarcoma With Different IDH Genotypes

There is no standard treatment for chondrosarcoma. Some small sample of studies has shown that anti-angiogenic TKIs show certain activity in the treatment of chondrosarcoma. PD-1 inhibitors, in recent years, have also been used in clinical practice and showed good efficacy. We intend to explore the response of chondrosarcoma to PD-1 monoclonal antibody and the influence of different IDH genotypes on PD-1 monoclonal antibody response.

Read the detailed description

We intend to explore the response of chondrosarcoma to PD-1 monoclonal antibody and the influence of different IDH genotypes on PD-1 monoclonal antibody response. Patients with unresectable locally advanced or metastatic chondrosarcomas(CS), including high-grade (II-III) ordinary CS and dedifferentiated CS, are qualified. The experimental group was PD-1 monoclonal antibody combined with Anlotinib for treatment of unresectable locally advanced or metastatic CS, and the control group was anlotinib monotherapy. The treatment is continuous until the disease progression or intolerable toxicity. CS with disease progression in the control group was allowed to enter the experimental group to continue treatment. The primary endpoint was 6-month PFSR.

Conditions: Chondrosarcoma
Being tested: Anlotinib hydrochloride, PD-1 inhibitor
Keywords: Chondrosarcoma Anlotinib PD-1 monoclonal antibody
Medical subject headings: Chondrosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Anlotinib hydrochlorideDrug
Also called FuKeWei
Anlotinib 12mg per person per day, continuous medication for 2 weeks and 1 week off, 3 weeks 1 cycle, until disease progression or intolerable toxicity
PD-1 inhibitorDrug
Intravenous injection, once every 3 weeks, until the disease progression or intolerable toxicity

Study groups in NCT05193188
Study group	Role	What they receive
Anlotinib combined with PD-1 monoclonal antibody	Experimental	Anlotinib, a multi-target tyrosine kinase inhibitor，oral，12mg/10mg/8mg，2 weeks on and 1 week off; PD-1 monoclonal antibody，PD-1 inhibitor，Intravenous injection，once 3 week. Receives: Drug: Anlotinib hydrochloride; Drug: PD-1 inhibitor
Anlotinib monotherapy	Active comparator	Anlotinib, a multi-target tyrosine kinase inhibitor，oral，12mg/10mg/8mg，2 weeks on and 1 week off. Receives: Drug: Anlotinib hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

6month-PFSR
Proportion of no disease progression after 6 months of medication
Measured: 6month

Secondary outcomes (2)

ORR
the proportion of patients with complete remission and partial remission
Measured: 6month
DCR
the proportion of patients with complete remission, partial remission and stable disease.
Measured: 6month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Feb 202331 Mar 2026

First posted14 Jan 2022
Study start6 Feb 2023
Primary completion31 Mar 2025 (estimated)
Study completion31 Mar 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ChondrosarcomaStudies 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 70 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05193188
Sponsor's protocol ID: LS2021-387
Status last verified: Feb 2023
First submitted: 26 Dec 2021
Last updated: 16 Feb 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Li B, Xie L, Liang J, Jiang Y, Wang K, Liu Y, Lin N, Huang X, Zhao K, Fan G, Liu M, Yan X, Qu H, Li H, Yang J, Zhou G, Ye Z. Anti-PD-1 antibody plus anlotinib vs. anlotinib alone in patients with refractory chondrosarcoma: A multicenter, non-randomized phase 2 FLAIL-C trial. Med. 2025 Nov 14;6(11):100809. doi: 10.1016/j.medj.2025.100809. Epub 2025 Aug 28.
PubMed 40882625

Want to know more?

Zhaoming Ye, Medical PhD

86-0571-87783777

yezhaoming@zju.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Enasidenib in IDH2-Mutated Malignant Sinonasal and Skull Base Tumors
Metastatic Chondrosarcoma, Locally Advanced Chondrosarcoma
Active, not recruiting
Clear Cell Chondrosarcoma in Italy
Chondrosarcoma
RecruitingPhase 3
Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 or 2 Systemic Treatment Regimens
Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen
Active, not recruiting
High Dose Intensity Modulated Proton Radiation Treatment +/- Surgical Resection of Sarcomas of the Spine, Sacrum and Base of Skull
Chordoma of Spine, Chordoma of Sacrum
Active, not recruitingPhase 2
Testing Ipilimumab and Nivolumab Combination With or Without Cabozantinib in People >= 18 Years Old With Advanced Soft Tissue Sarcoma
Locally Advanced Extraskeletal Myxoid Chondrosarcoma, Locally Advanced Leiomyosarcoma

All Chondrosarcoma trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter Clinical Controlled Study of Anlotinib Combined With PD-1 Antibody on Unresectable High-grade Chondrosarcoma With Different IDH Genotypes
ClinicalTrials.gov ID: NCT05193188
Acronym / sponsor ID: LS2021-387
Conditions: Chondrosarcoma
Keywords: Chondrosarcoma Anlotinib PD-1 monoclonal antibody
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 70 participants (estimated)
Lead sponsor: Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
Study start: 6 Feb 2023 (actual)
Primary completion: 31 Mar 2025 (estimated)
Study completion: 31 Mar 2026 (estimated)
First posted: 14 Jan 2022 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Anlotinib combined with PD-1 monoclonal antibody	Experimental	Drug: Anlotinib hydrochloride, Drug: PD-1 inhibitorAnlotinib, a multi-target tyrosine kinase inhibitor，oral，12mg/10mg/8mg，2 weeks on and 1 week off; PD-1 monoclonal antibody，PD-1 inhibitor，Intravenous injection，once 3 week.
Anlotinib monotherapy	Active comparator	Drug: Anlotinib hydrochlorideAnlotinib, a multi-target tyrosine kinase inhibitor，oral，12mg/10mg/8mg，2 weeks on and 1 week off.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

1. Age ≥18 years old, no gender limit; 2. ECOG PS score 0-2 points; 3. unresectable locally advanced or metastatic chondrosarcoma confirmed by histopathology, including high-grade (grade II-III) conventional CS and dedifferentiated CS; 4. Allow previous surgery, radiotherapy, or chemotherapy therapies; 5. Have at least 1 measurable lesion in accordance with the RECIST1.1; 6. The main organs are functioning normally and meet the following criteria within 7 days before treatment:
③ Urine protein <2+, and 24h urine protein quantitatively shows that the protein must be ≤ 1g;
④ Coagulation function: INR <2.0 and APTT≤1.5×ULN
⑤ Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ lower limit of normal value (60%)

Key exclusion criteria (32 listed)

1. Received anti-CTLA-4/PD-1/PD-L1 antibody treatment previously ; 2. Received anti-angiogenic TKI drugs (such as Anlotinib, Apatinib, Regofenib, etc.) or anti-angiogenic antibody drugs (such as Bevacizumab) previously; 3. Received other anti-tumor treatments within 4 weeks before enrollment, including systemic therapy, radiotherapy, major surgery, open biopsy, or participated in other clinical trials; 4. Patients who have not recovered from adverse events caused by any previous treatment to NCI-CTCAE (5.0) ≤1, excluding hair loss; 5. The investigator determines that there is a significant risk of bleeding, including but not limited to:

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
Anlotinib hydrochlorideAlso: FuKeWeiAnlotinib 12mg per person per day, continuous medication for 2 weeks and 1 week off, 3 weeks 1 cycle, until disease progression or intolerable toxicity	Drug	Anlotinib combined with PD-1 monoclonal antibody, Anlotinib monotherapy
PD-1 inhibitorIntravenous injection, once every 3 weeks, until the disease progression or intolerable toxicity	Drug	Anlotinib combined with PD-1 monoclonal antibody

Primary outcome

6month-PFSR
Time frame: 6month
Proportion of no disease progression after 6 months of medication

2 secondary outcomes

ORR
Time frame: 6month
DCR
Time frame: 6month

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
Derived from this study: PubMed 40882625Li B, Xie L, Liang J, Jiang Y, Wang K, Liu Y, Lin N, Huang X, Zhao K, Fan G, Liu M, Yan X, Qu H, Li H, Yang J, Zhou G, Ye Z. Anti-PD-1 antibody plus anlotinib vs. anlotinib alone in patients with refractory chondrosarcoma: A multicenter, non-randomized phase 2 FLAIL-C trial. Med. 2025 Nov 14;6(11):100809. doi: 10.1016/j.medj.2025.100809. Epub 2025 Aug 28.
Individual participant dataSharing planned: No

Related trials for Chondrosarcoma

RecruitingPhase 2
Enasidenib in IDH2-Mutated Malignant Sinonasal and Skull Base Tumors
Metastatic Chondrosarcoma, Locally Advanced Chondrosarcoma
Active, not recruiting
Clear Cell Chondrosarcoma in Italy
Chondrosarcoma
RecruitingPhase 3
Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 or 2 Systemic Treatment Regimens
Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen
Active, not recruiting
High Dose Intensity Modulated Proton Radiation Treatment +/- Surgical Resection of Sarcomas of the Spine, Sacrum and Base of Skull
Chordoma of Spine, Chordoma of Sacrum
Active, not recruitingPhase 2
Testing Ipilimumab and Nivolumab Combination With or Without Cabozantinib in People >= 18 Years Old With Advanced Soft Tissue Sarcoma
Locally Advanced Extraskeletal Myxoid Chondrosarcoma, Locally Advanced Leiomyosarcoma

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.

Zhaoming Ye, Medical PhD contact

86-0571-87783777

yezhaoming@zju.edu.cn

Binghao Li, Medical PhD principal investigator

Second Affiliated Hospital of 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 Anlotinib hydrochloride and PD-1 inhibitor in people with Chondrosarcoma, 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 13 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2023. 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?

Contact Zhaoming Ye, Medical PhD (86-0571-87783777, yezhaoming@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6month-PFSR (time frame: 6month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05193188, which also lists 1 linked publication.

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 16 Feb 2023.