Dedifferentiated LiposarcomaPhase 2NCT06694324
First-line Treatment of Advanced/unresectable DDLPS
A Phase 2 study testing Liposomal Doxorubicin (Doxil), Apatinib and Camrelizumab in people with Dedifferentiated Liposarcoma and Soft Tissue Sarcoma (STS), run by Fudan University at 1 site in China.
Trial summary
Evaluating the efficacy and safety of liposomal doxorubicin hydrochloride and apatinib in combination with camrelizumab for the first-line treatment of advanced/unresectable dedifferentiated liposarcoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dedifferentiated Liposarcoma, Soft Tissue Sarcoma (STS)
- What is being tested?
- Liposomal Doxorubicin (Doxil), Apatinib and Camrelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 1 Dec 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years, male or female;
- Histologically confirmed dedifferentiated liposarcoma;
- metastatic stage not having received systemic therapy;
- no brain metastases;
- ECOG PS: 0~1 points;
- normal function of major organs, meeting the following requirements (within 7 days prior to initiation of study treatment): 1)Left ventricular ejection fraction (LVEF) ≥50%; 2)Normal electrocardiogram; 3)Hemoglobin [HB] ≥ 90 g/L; 4)Absolute neutrophil count [ANC] ≥1.5×109/L; 5) Platelet [PLT] ≥100×109/L; 6)Serum total bilirubin [TBIL] ≤1.5 times the upper limit of normal (ULN); 7) alanine aminotransferase [ALT], aspartate aminotransferase [AST] <2.5 × ULN; if there are liver metastases, ALT and AST ≤5 × ULN; 8) Serum creatinine [Cr] ≤ 1 × ULN or endogenous creatinine clearance > 50 ml/min (Cockcroft-Gault formula);
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- women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and voluntarily use an appropriate method of contraception for the duration of the observation period and for 8 weeks after the final administration of study drug; in the case of males, they should be surgically sterilized or agree to use an appropriate method of contraception for the duration of the observation period and for 8 weeks after the final administration of study drug;
- expected to have good compliance and be able to follow up on efficacy and adverse effects as required by the protocol;
- sign an informed consent form.
Who cannot join
- patients with recurrence within six months of postoperative adjuvant therapy;
- previous adjuvant or neoadjuvant phase with cumulative dose of doxorubicin, liposomal doxorubicin, or other anthracyclines ≥ 240 mg/m2;
- Use of PD-1 or PD-L1 inhibitors in prior adjuvant or neoadjuvant phase;
- patients with prior adjuvant or neoadjuvant phase use of apatinib mesylate and patients with prior treatment with vascular endothelial growth inhibitor-targeted agents such as sunitinib, sorafenib, bevacizumab, imatinib, famitinib, pazopanib, regorafenib, and erlotinib.
- Other active malignancies within 5 years or concurrently;
- central nervous system involvement;
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- clinical symptoms or diseases of the heart that are not well controlled, such as (1) cardiac insufficiency of grade II or higher according to the New York Heart Association (NYHA) criteria or cardiac ultrasound: LVEF (Left Ventricular Ejection Fraction) < 50%; (2) unstable angina pectoris; (3) myocardial infarction within 1 year prior to the start of study treatment; (4) clinically significant supraventricular or ventricular arrhythmia Need for treatment or intervention: (5) QTc >450 ms (men); QTc >470 ms (women) (QTc intervals are calculated using the Fridericia formula; if the QTc is abnormal, three consecutive measurements may be taken at approximately 2-minute intervals and averaged);
- patients with signs or history of bleeding, regardless of severity; any bleeding or bleeding event CTCAE grade 3 within 4 weeks prior to enrollment, unhealed wounds, ulcers, or fractures
- those with hypertension that cannot be reduced to the normal range (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg) with antihypertensive medication (based on the average of BP readings obtained from ≥2 measurements) are permitted to achieve the above parameters with the use of antihypertensive therapy;
- patients with severe hepatic or renal insufficiency (grade 4);
- poorly controlled diabetes mellitus (FBG) > 10 mmol/L);
- Patients with active ulcers, intestinal perforation, intestinal obstruction;
- Routine urinalysis showing urinary protein++, confirming 24-hour urine protein quantification >1.0g;
- Presence of active autoimmune disease or history of autoimmune disease with possible relapse;
- Uncontrolled infection or unexplained fever >38.5°C at screening;
- a known history of severe allergy to the study drug;
- other patients deemed unsuitable for inclusion by the treating physician.
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
Fudan University, Cancer Hospital
Shanghai, Shanghai Municipality
Xin Liu, MD, 0086-18017317720, jeanettexin@hotmail.com
About this study
Official title: Liposomal Doxorubicin Hydrochloride and Apatinib in Combination with Camrelizumab for the First-line Treatment of Advanced/unresectable Dedifferentiated Liposarcoma
Evaluating the efficacy and safety of liposomal doxorubicin hydrochloride and apatinib in combination with camrelizumab for the first-line treatment of advanced/unresectable dedifferentiated liposarcoma
Read the detailed description
Based on the clinical benefits provided by doxorubicin liposome, apatinib and camrelizumab treatment in STS, this study intends to explore the efficacy and safety of doxorubicin liposome hydrochloride and apatinib combined with camrelizumab in the first-line treatment of advanced/unresectable dedifferentiated liposarcoma with the aim of providing a better therapeutic option for the clinic.
- Being tested
- Liposomal Doxorubicin (Doxil), Apatinib, Camrelizumab
- Keywords
- liposomal doxorubicin, apatinib, Camrelizumab, first line treatment
- Medical subject headings
- Liposarcoma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal Doxorubicin (Doxil)Drug
30 mg/m2, d1, IV
ApatinibDrug
250 mg, qd
CamrelizumabDrug
200 mg, d1, IV
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Doxorubicin+Apatinib+Camrelizumab | Experimental | The patients with advanced or unresectable de-differentiated liposarcoma will be enrolled and given Liposomal doxorubicin hydrochloride: 30 mg/m2, d1, IV over 30 min; apatinib: 250 mg, qd; and karelizumab: 200 mg, d1, IV; Q3W, continued treatment for 6 cycles followed by apatinib and camrelizumab until disease progression, development of unacceptable toxicity, or death of the patient or 2 years of treatment. Receives: Drug: Liposomal Doxorubicin (Doxil); Drug: Apatinib; Drug: Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate, ORR
the best response rate
Measured: up to two years
Secondary outcomes (3)
progression free survival, PFS
from first dose treatment to disease progression
Measured: up to three years
overall survival, OS
overall survival
Measured: up to three years
adverse events, AE
treatment related adverse events, TRAEs
Measured: up to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dedifferentiated LiposarcomaStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiguo Luo, MD, PhD, Fudan University
- Investigators
- Zhiguo Luo, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694324
- Sponsor's protocol ID
- Fudan-CMS-001
- Status last verified
- Sep 2024
- First submitted
- 12 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The researchers decided not to share
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liposomal Doxorubicin Hydrochloride and Apatinib in Combination with Camrelizumab for the First-line Treatment of Advanced/unresectable Dedifferentiated Liposarcoma
- ClinicalTrials.gov ID
- NCT06694324
- Acronym / sponsor ID
- Fudan-CMS-001
- Keywords
- liposomal doxorubicin, apatinib, Camrelizumab, first line treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 19 Nov 2024 (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.
Evaluating the efficacy and safety of liposomal doxorubicin hydrochloride and apatinib in combination with camrelizumab for the first-line treatment of advanced/unresectable dedifferentiated liposarcoma
Detailed description
Based on the clinical benefits provided by doxorubicin liposome, apatinib and camrelizumab treatment in STS, this study intends to explore the efficacy and safety of doxorubicin liposome hydrochloride and apatinib combined with camrelizumab in the first-line treatment of advanced/unresectable dedifferentiated liposarcoma with the aim of providing a better therapeutic option for the clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liposomal Doxorubicin+Apatinib+Camrelizumab | Experimental | Drug: Liposomal Doxorubicin (Doxil), Drug: Apatinib, Drug: CamrelizumabThe patients with advanced or unresectable de-differentiated liposarcoma will be enrolled and given Liposomal doxorubicin hydrochloride: 30 mg/m2, d1, IV over 30 min; apatinib: 250 mg, qd; and karelizumab: 200 mg, d1, IV; Q3W, continued treatment for 6 cycles followed by apatinib and camrelizumab until disease progression, development of unacceptable toxicity, or death of the patient or 2 years of treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-75 years, male or female;
- Histologically confirmed dedifferentiated liposarcoma;
- metastatic stage not having received systemic therapy;
- no brain metastases;
- ECOG PS: 0~1 points;
Key exclusion criteria (17 listed)
- patients with recurrence within six months of postoperative adjuvant therapy;
- previous adjuvant or neoadjuvant phase with cumulative dose of doxorubicin, liposomal doxorubicin, or other anthracyclines ≥ 240 mg/m2;
- Use of PD-1 or PD-L1 inhibitors in prior adjuvant or neoadjuvant phase;
- patients with prior adjuvant or neoadjuvant phase use of apatinib mesylate and patients with prior treatment with vascular endothelial growth inhibitor-targeted agents such as sunitinib, sorafenib, bevacizumab, imatinib, famitinib, pazopanib, regorafenib, and erlotinib.
- Other active malignancies within 5 years or concurrently;
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 |
|---|---|---|
| Liposomal Doxorubicin (Doxil)30 mg/m2, d1, IV | Drug | Liposomal Doxorubicin+Apatinib+Camrelizumab |
| Apatinib250 mg, qd | Drug | Liposomal Doxorubicin+Apatinib+Camrelizumab |
| Camrelizumab200 mg, d1, IV | Drug | Liposomal Doxorubicin+Apatinib+Camrelizumab |
Primary outcome
overall response rate, ORR
Time frame: up to two years
the best response rate
3 secondary outcomes
progression free survival, PFS
Time frame: up to three years
overall survival, OS
Time frame: up to three years
adverse events, AE
Time frame: up to three years
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 19 Nov 2024.
- Individual participant dataSharing planned: No. The researchers decided not to share
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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.
Zhiguo Luo, MD, PhD principal investigator
Fudan University
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 Liposomal Doxorubicin (Doxil), Apatinib and Camrelizumab in people with Dedifferentiated Liposarcoma and Soft Tissue Sarcoma (STS), run by Fudan 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 9 inclusion and 17 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 19 Nov 2024. 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 Xin Liu, MD (0086-021-64175590, jeanettexin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate, ORR (time frame: up to two years). 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 19 Nov 2024.