Apatinib Mesylate Combined With Doxorubicin and Ifosfamide in Advanced Soft-tissue Sarcoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04012827|
Recruitment Status : Recruiting
First Posted : July 9, 2019
Last Update Posted : September 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma||Drug: Apatinib Mesylate, doxorubicin, ifosfamide||Phase 2|
Apatinib mesylate has demonstrated good efficacy and acceptable safety in patients with metastatic or recurrent soft tissue sarcoma (STS). A retrospective study has evaluated the efficacy of apatinib in the treatment of advanced soft tissue sarcoma. A total of 31 patients with soft tissue sarcoma were enrolled in this study, including 4 patients receiving apatinib first-line treatment, 8 patients receiving second-line treatment, and 19 patients receiving third-line or post-third-line treatment. The results showed that ORR 33.3%, DCR 75%, and mTTP 4.6 months (1.8-11.6 months). In another multicentric retrospective study of apatinib for osteosarcoma and soft tissue sarcoma, a total of 56 patients were enrolled and 44 were treated with apatinib monotherapy. The overall results showed that ORR was 62.5%, mPFS was 6.6 months, and mOS was 9.9 months. In a phase II multi-center single-arm study results published by Yang Jilong Yang et al at the 2018 AACR conference, ORR and DCR at 3 months also reached 13.95% and 81.39%, respectively. The end point assessment ORR was further increased to 15.25% at the end of the study, because some patients achieved partial remission after a long period of treatment, and the final DCR reached 57.63%. Apatinib had a significant effect in the treatment of stage IV osteosarcoma with failed chemotherapy. Jing Chen et al published a study researching the effectiveness and security in advanced sarcoma patients after apatinib treatment , the results show that 24.3% of subjects to achieve objective response, including 1 case of adenoid vesicular soft tissue sarcoma patients achieved CR, seven adenoid vesicular soft tissue sarcoma patients achieved the objective response, indicates that apatinib is effective and well tolerated in some specific sarcoma subtype.
In this study ,Apatinib mesylate combined with doxorubicin and ifosfamide regimens were evaluated in the treatment of advanced or inoperable STS to determine the potential to achieve better outcomes.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-arm, Open, Multicenter Study of Apatinib Mesylate Combined With Doxorubicin and Ifosfamide in Advanced Soft-tissue Sarcoma|
|Actual Study Start Date :||August 20, 2019|
|Estimated Primary Completion Date :||October 15, 2021|
|Estimated Study Completion Date :||October 31, 2021|
Experimental: Apatinib Mesylate Combined With Doxorubicin and Ifosfamide
A course of treatment every 21 days. For patients with disease control (CR+ PR+SD) and tolerable adverse reactions after 6 courses of treatment, continuous drug use was considered by the researchers as inappropriate for patients to continue drug use or when the efficacy was assessed as disease progression (PD).No other antitumor treatment can be given during the treatment.
Drug: Apatinib Mesylate, doxorubicin, ifosfamide
Doxorubicin 50mg/m2 d1 , Ifosfamide 2.5g/m2 d1-3 , Apatinib mesylate 375mg qd
Other Name: Apatinib
- Objective Response Rate [ Time Frame: up to 24 months ]Objective response rate is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior to progression or any further therapy.
- Progress free survival [ Time Frame: From treatment until progression (up to 24 months) ]Progress free survival defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.
- Overall Survival [ Time Frame: From treatment until death (up to 24 months) ]Overall survival is defined as the time until death due to any cause.
- Disease Control Rate [ Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) ]Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04012827
|Contact: Xing Zhangemail@example.com|
|Sun Yat-sen University Cancer Center||Recruiting|
|Contact: Xing Zhang|