Advanced Cancer Clinical Trial
Official title:
Apatinib for Advanced Soft Tissue Sarcoma Patients After Failure of Traditional Therapy: an One-armed, Phase 2, Open-label, Multicenter Prospective Trial
Patients with advanced soft tissue sarcoma(rhabdomyosarcoma and liposarcoma excluded), who experience progression after standard chemotherapy, have limited treatment options which promise a survival benefit.This trial tends to explore apatinib, which is a domestic highly selective inhibitor of vascular endothelial growth factor receptor-2, as a treatment option for heavily pretreated soft tissue sarcoma patients.
From April 1st 2017 to June 1st 2019, participants who met the following criteria were
included: 1) histologically confirmed high-grade soft tissue sarcoma(rhabdomyosarcoma and
liposarcoma excluded); 2) initial treated in the orthopedic oncology departments of three
affiliated hospitals of Peking University,including Peking University People's Hospital,
Peking University Shougang Hospital and Peking University International Hospital; 3) not
amenable to curative treatment; 4) multiple metastatic lesions which could not be cured by
local therapy or unresectable local advanced lesions; 5) having measurable lesions according
to Response Evaluation Criteria for Solid Tumors 1.1(RECIST 1.1); 6) expected to live longer
than 3 months with an Eastern Cooperative Oncology Group performance status of 0 or 1 and
acceptable hematologic, hepatic, and renal function; 7) needed to be verified refractory to
doxorubicin and ifosfamide.
All those participants need to sign informed consent forms for data collection and use for
research purpose before inclusion, of which children patients' informed forms should be
signed by their legal parents. Once the patient registered, he/she will be evaluated by
his/her doctors of these departments at the clinic, and his/her follow-up should be done
every eight weeks with at least chest CT as well as imaging of tumor lesions at other sites.
A follow-up file should be sent every eight weeks to the coordination desk of these
departments. This study was approved by the institutional review board, Peking University
People's Hospital, Peking University Shougang Hospital and Peking University International
Hospital Ethics Committee for Clinical Investigation, and conducted in accordance with the
Declaration of Helsinki and Good Clinical Practice.
The investigators demand patients to use at least doxorubicin and ifosfamide. In a phase I
trial, apatinib (Jiangsu Hengrui Medicine, Lianyungang, China) showed good oral
bioavailability at a dose of 850 mg a day, the maximum-tolerated dose. Considering this, the
participants are designed to receive 750 mg daily once oral administration of apatinib for
body surface area (BSA) > 1.5 and 500mg daily for BSA <1.5. If the investigators meet with
treatment interruptions because of grade 3 hematologic or grade 2 non-hematologic toxicities,
dose reductions to 750 mg or 500 mg of apatinib per day, and supportive care should be
allowed for the management of adverse events (AEs).
The primary objective is to describe the efficacy of apatinib in sarcoma patients. Endpoints
is objective response rate (CR+PR) and Progression-Free-Survival (PFS) for each protocol as
described containing apatinib according to RECIST 1.1. The secondary objective is overall
survival (OS), duration of response (DR) and the characterization of toxicities. PFS is
defined as the time from the start of using apatinib until disease progression or death,
whichever occurs first. OS is defined as the time from the start of using apatinib until
death. The period from appearance of response or stable disease to progression or death is
thus considered the duration of response (DR).
Safety evaluation will be based on the frequency and severity of toxicities graded according
to the Common Terminology Criteria for Adverse Events.
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