Albumin-bound Paclitaxel Combined With Liposomal Doxorubicin in the Treatment of Advanced or Unresectable Angiosarcoma

NCT04859465 | Unknown Phase 2

• 1 other identifier: Angiosarcoma
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose is to explore the efficacy and safety of the combination of albumin-bound paclitaxel and liposomal doxorubicin in the treatment of advanced or unresectable angiosarcoma.

Conditions

Angiosarcoma Metastatic

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  Overall response rate (ORR) of patients with advanced or unresectable angiosarcoma treated with abraxane combined with liposomal doxorubicin

  up to 24 months

Study Arms (1)

Abraxane combined with liposomal doxorubicin

EXPERIMENTAL

Abraxane combined with liposomal doxorubicin in the treatment of advanced or unresectable angiosarcoma

Drug: Abraxane combined with liposomal doxorubicin

Interventions

Abraxane combined with liposomal doxorubicin DRUG

Patients with advanced or unresectable angiogenic sarcoma who met the criteria of treatment failure received abraxane combined with liposomal doxorubicin regimen. Administration regimen: abraxane 220 mg / m2 D1 plus liposomal doxorubicin 35 mg / m2 D1, IV drip, 3 weeks as a cycle, until the disease progression or intolerable toxicity. Up to 8 cycles.

Abraxane combined with liposomal doxorubicin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients voluntarily participated in the study and signed the informed consent; In all advanced angiogenic sarcomas confirmed by pathology, the standard treatment failed or there was no standard treatment or the standard treatment could not be tolerated. There is at least one measurable lesion according to RECIST 1.1, mainly including angiosarcoma, epithelioid hemangioendothelioma, epitheliosarcoma hemangioendothelioma, pseudomyogenic hemangioendothelioma, Kaposi sarcoma, malignant solitary fibroma / hemangiopericytoma, malignant glomus tumor, etc.
• Patients in advanced stage with unresectable lesions or lymph node or distant metastasis by imaging evaluation;
• In the past three months, there was at least one target lesion that could be measured according to RECIST version 1.1 standard, and it could be accurately measured in at least one direction (the maximum diameter needs to be recorded) by MRI or CT, including conventional CT ≥ 20 mm or spiral CT ≥ 10 mm.
• years old; ECOG PS score: 0-1; the expected survival time was more than 3 months;
• The main organ function met the following criteria within 7 days before treatment (1) Blood routine examination standard (without blood transfusion within 14 days)
• Hemoglobin (HB) ≥ 90g / L; ② Absolute neutrophil count (ANC) ≥ 1.5 × 109 / L;
• ③ Platelet count (PLT) ≥ 80 × 109 / L.
• (2) Biochemical tests should meet the following standards:
• Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); ② Alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5 × ULN ALT and AST ≤ 5 ×ULN in patients with liver metastasis; ③ Serum creatinine (CR) ≤ 1.5 × ULN or creatinine clearance rate (CCR) ≥ 60ml / min;
• (3) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ the lower limit of normal value (50%).
• Women of childbearing age should agree to use contraceptive measures (such as intrauterine device, contraceptive or condom) during the study period and within 6 months after the end of the study; women with negative serum or urine pregnancy test within 7 days before the study and must be non lactation patients; men should agree to use contraceptive measures during the study period and within 6 months after the end of the study period.

You may not qualify if:

• \) Patients who have previously received abraxane treatment.
• \) There were other malignant tumors in the past 5 years or at the same time, except for the cured cervical carcinoma in situ, skin cancer without melanoma and superficial bladder tumor (TA (non invasive tumor), tis (in situ cancer) and T1 (tumor infiltrating basement membrane);
• \) Systemic anti-tumor treatment, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or mitomycin C use within 6 weeks prior to the treatment of the trial drug), is planned within 4 weeks before the group is given or during the study medication. The radiotherapy was performed within 4 weeks before the group or the limited field radiotherapy was performed within 2 weeks before the group;
• \) With pleural effusion or ascites, respiratory syndrome (≥ CTC AE class 2 dyspnea (dyspnea 2 refers to shortness of breath when a small amount of activity is used; It can affect instrumental daily life activities);
• \) No remission of toxic reactions caused by any previous treatment was higher than that of CTC AE (4.01), excluding hair loss and lymphocyte reduction;
• \) Patients with any serious and / or uncontrollable diseases, including:
• The patients with poor blood pressure control (systolic pressure ≥ 150 mmHg and diastolic pressure ≥ 100 mmHg) were found;
• Patients with myocardial ischemia or myocardial infarction, arrhythmia (including QTc ≥ 480ms) and ≥ 2 congestive heart failure (NYHA classification);
• Active or uncontrollable severe infection (≥ CTC AE Level 2 infection);
• Cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis need to be treated with antiviral treatment;
• Renal failure requires hemodialysis or peritoneal dialysis;
• The control of diabetes mellitus was not good (FBG) was more than 10mmol/l;
• The routine urine suggested that the urine protein was ≥ + +, and the 24-hour urine protein was more than 1.0 G;
• Patients with epilepsy and need treatment;
• \) The patients were treated with major surgery, incision biopsy or obvious traumatic injury within 28 days before entering the group;

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Xing Zhang

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Interventions

liposomal doxorubicin

Study Officials

• Xing Zhang

  Sun Yat-sen University CancerCenter

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xing Zhang

CONTACT

02087343383; zhangxing@sysucc.org.cn

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: Director of department of medical sarcoma and melanoma,Principal Investigator,Clinical Professor

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 26, 2021
• Study Start: May 21, 2021
• Primary Completion: May 20, 2024
• Study Completion: November 20, 2024
• Last Updated: December 27, 2023

Record last verified: 2023-12

Locations

CN (1)