First-line Treatment of Advanced/unresectable DDLPS

NCT06694324 | Not Yet Recruiting Phase 2

• 1 other identifier: Fudan-CMS-001
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Dedifferentiated Liposarcoma; Soft Tissue Sarcoma (STS)

Keywords

liposomal doxorubicin; apatinib; Camrelizumab; first line treatment

Outcome Measures

Primary Outcomes (1)

• overall response rate, ORR

  the best response rate

  up to two years

Secondary Outcomes (3)

• progression free survival, PFS

  up to three years

• overall survival, OS

  up to three years

• adverse events, AE

  up to three years

Study Arms (1)

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.

Drug: Liposomal Doxorubicin (Doxil); Drug: Apatinib; Drug: Camrelizumab

Interventions

Liposomal Doxorubicin (Doxil) DRUG

30 mg/m2, d1, IV

Liposomal Doxorubicin+Apatinib+Camrelizumab

Apatinib DRUG

250 mg, qd

Liposomal Doxorubicin+Apatinib+Camrelizumab

Camrelizumab DRUG

200 mg, d1, IV

Liposomal Doxorubicin+Apatinib+Camrelizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University, Cancer Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Liposarcoma; Sarcoma

Interventions

liposomal doxorubicin; apatinib; camrelizumab

Condition Hierarchy (Ancestors)

Neoplasms, Adipose Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Zhiguo Luo, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Liu, MD

CONTACT

0086-021-64175590; jeanettexin@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Clinical Professor

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 19, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)