Anlotinib Combined With Toripalimab in Refractory and Advanced Soft-tissue Sarcoma (NCT04172805) | Clinical Trial Compass
CompletedPhase 2
Anlotinib Combined With Toripalimab in Refractory and Advanced Soft-tissue Sarcoma
China70 participantsStarted 2020-03-13
Plain-language summary
Soft tissue sarcoma (STS) is a relatively rare type of malignant tumor with an incidence of 1-2/100000. For unresectable or widely disseminated advanced STS, a combined clinical trial is the best way to obtain evidence-based medical evidence.
Anlotinib, a multi-target receptor tyrosine kinase inhibitor (TKI), is effective for various histological types of STS and the safety is tolerable. TKIs may reverse drug resistance or inefficiency of immunoassay inhibitors, and combination therapy has shown preliminary efficacy in a variety of tumors.
Because of the poor prognosis of refractory and advanced STS, there is no standard second-line treatment. Therefore, combined therapies based on the original targeted drugs would be paid more concentrations in the future. We focus on exploring the feasibility of combination of anlotinib and Toripalimab monoclonal antibody in advanced, refractory and progressive soft tissue sarcoma after failure of standard treatment, and look forward to further improving the efficacy of soft tissue sarcoma.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients voluntarily joined the study and signed informed consent, with good adherence and follow-up.
. Male or female patients aged 18-70 years, ECOG PS score: 0 to 2 points; expected survival over 3 months.
. All advanced soft tissue sarcomas, first-line treatment failure or inability to tolerate first-line treatment, diagnosed by histology, at least one measurable lesion according to RECIST 1.1, including synovial sarcoma, leiomyosarcoma, alveolar soft tissue sarcoma, undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma, liposarcoma, fibrosarcoma, clear cell sarcoma, angiosarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumor, undifferentiated sarcoma, dermatofibrosarcoma, inflammatory myofibroblast sarcoma, malignant solitary fibroids. However, the following types can be treated first-line: alveolar soft tissue sarcoma, well differentiated / dedifferentiated / pleomorphic liposarcoma, clear cell sarcoma;
. At least one target lesion measurable according to RECIST version 1.1 in the past 3 months, and in at least 1 direction (maximum diameter required to be recorded) can be obtained by magnetic resonance imaging (MRI) or computed tomography (CT) Accurate measurement, where conventional CT ≥ 20 mm or ≥ 10 mm under spiral CT.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate
Timeframe: Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
. The main organ function meets the following criteria within 7 days of treatment:
. Women of childbearing age must have taken reliable contraceptive measures and performed a pregnancy test (serum or urine) within 7 days prior to enrollment, and the results were negative, and were willing to use appropriate methods during the trial and 8 weeks after the last administration of the test drug. For men, consent must be given to the appropriate method of contraception or surgical sterilization during the trial and 8 weeks after the last administration of the test drug.
Exclusion criteria
. Patients who have previously been treated with anlotinib or anti-PD-1/PD-L1 antibodies.
. Exceeded or currently suffering from other malignant tumors within 5 years, with the exception of cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors \[Ta (non-invasive tumor), Tis (in situ carcinoma) And T1 (tumor infiltrating basement membrane)\].
. Planning to use cytotoxic therapy, signal transduction inhibitors, immunotherapy (or mitomycin C used within 6 weeks prior to receiving the test drug) within 4 weeks prior to enrollment or during the study. Radiation-rehabilitation radiotherapy (EF-RT) was performed within 4 weeks prior to enrollment or limited-field radiotherapy to be evaluated for tumor lesions within 2 weeks prior to grouping.
. Hair loss is not included due to unresolved toxicities above CTC AE Level 1 for any prior treatment.
. A variety of factors that affect oral medications (such as inability to swallow, chronic diarrhea, and intestinal obstruction), and symptomatic treatment is uncontrollable.
. With pleural effusion or ascites, causing respiratory syndrome (≥ CTC AE grade 2 dyspnea \[level 2 dyspnea refers to short-term shortness of activity; affecting instrumental activities of daily living\]), and symptomatic treatment is uncontrollable.
. Active central nervous system (CNS) metastases with clinical signs including cerebral edema, steroid requirements, or progressive disease. Patients with previously treated brain or meningeal metastases must be clinically stable (magnetic resonance imaging \[MRI\] shows no evidence of new or enlarged metastases at least 4 weeks apart) and stop the immunosuppressant amount of systemic steroids (\> 10 Mg / day) prednisone or equivalent) at least 2 weeks prior to study drug administration.
. Patients with abnormal thyroid function after optimal drug treatment.