Trial Title:
Geno-radiomics Based Model for Evaluation of Immunotherapy and Targeted Therapy for Advanced Soft Tissue Sarcoma
NCT ID:
NCT06062927
Condition:
Advanced Soft Tissue Sarcoma
Conditions: Official terms:
Sarcoma
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
In this study, a new post-processing image technology - radiomics is used to screen out
parameters of CT and MRI images, which could effectively evaluate the efficacy and
prognosis of immunotherapy plus targeted therapy for soft tissue sarcoma (STS). A
reliable and effective model for predicting the prognosis of STS will be established
based on the radiomic parameters combined with traditional imaging, histophiological,
whole exome sequencing (WES) results, inflammatory indicators and changes in the number
and function of lymphocyte subsets before and after medication. Patients with advanced
STS who may benefit from the combination therapy can be found out by this model.
Criteria for eligibility:
Study pop:
Patients with advanced soft tissue sarcoma receiving immunotherapy plus targeted therapy
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Male or female subjects aged from 18 to 75 years old;
- Subjects with histologically confirmed unresectable locally advanced or metastatic
soft tissue sarcoma, which includes synoviosarcoma, leiomyosarcoma, undifferentiated
pleomorphic sarcoma/malignant fibrous histiocytoma, fibrosarcoma, epithelioid
sarcoma, angiosarcoma, alveolar soft-part sarcoma, etc. Chondrosarcoma,
osteosarcoma, dermatofibrosarcoma protuberans, gastrointestinal stromal tumor and
malignant mesothelioma are excluded;
- Patients who agree to receive small molecule multi-target TKI and anti-PD-1 or
anti-PD-L1 monoclonal antibody therapy, without contraindications in the use of
related drugs;
- Disease must be measurable by Response Evaluation Criteria in Solid Tumors version
1.1 (RECIST 1.1). Previously irradiated focus can be considered as measurable only
if there is definite progress after radiotherapy;
- Newly obtained or archived tumor tissue samples can be provided;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2 at trial
entry;
- Estimated life expectancy of more than 12 weeks;
- Adequate organ functions defined by the protocol;
- Negative blood pregnancy test at Screening for women of childbearing potential
within 1 week before the first medication; Highly effective contraception for both
male and female subjects if the risk of conception exists; Able to comply with the
research protocol and follow-up process for treatment and follow-up;
- Already signed an informed consent form.
Exclusion Criteria:
- Patients whose tumors are judged by the investigators to be at high risk of invading
vital blood vessels and causing fatal hemorrhage during the study.
- Occurrence of arterial/venous thrombotic events within 6 months before treatment,
such as cerebrovascular accident (including transient ischemic attack,
hematencephalon and cerebral infarction), deep vein thrombosis , pulmonary embolism,
etc.
- Occurrence of clinically significant hemoptysis(>5ml fresh blood in 4 weeks),
hemorrhagic tendency(bleeding>30ml within 3 months), such as gastrointestinal
bleeding, hemorrhagic gastric ulcer, fecal occult blood test(FOBT) ++ in the
baseline period , or vasculitis, etc;
- Hypertension that cannot be controlled stably by drugs, which is defined as:
systolic blood pressure>140mmHg or diastolic blood pressure>90mmHg;
- With clinically significant cardiovascular diseases, including but not limited to:
acute myocardial infarction, severe/unstable angina pectoris or coronary artery
bypass grafting within 6 months before enrollment; congestive heart failure with New
York Heart Association (NYHA) grade≥2; cardiac revascularization, hemodynamic
unstable arrhythmia; Left ventricular ejection fraction(LVEF) <50%;
- QTc interval ≥ 480 milliseconds (ms) on electrocardiogram (ECG);
- 24-h urinary protein level >1.0g/day;
- Serum potassium, calcium (after correction for ionic or albumin-bound type) or
magnesium are beyond the normal range and have clinical significance.
- Abnormal coagulation function (INR>1.5 or PT>ULN+4s or APTT >1.5 ULN), hemorrhagic
tendency or being treated with thrombolysis or anticoagulation therapy. Notes: on
the premise of INR ≤ 1.5, it is allowed to use low-dose heparin (daily dosage of
adults is 6000-12000U) or low-dose aspirin (daily dosage ≤ 100mg) for preventive
purposes;
- With factors affecting oral drug administration: dysphagia, post-gastrointestinal
resection, chronic diarrhea and intestinal obstruction, etc
- Presence of known active central nervous system metastasis and/or cancerous
meningitis;
- With any active, known or suspected autoimmune disease (subjects who are in stable
status and do not need systemic immunosuppressant are allowed to be enrolled, such
as subjects with type 1 diabetes, hypothyroidism requiring hormone replacement
therapy only, skin diseases (leucoderma, psoriasis or alopecia) without the need for
systemic treatment or subjects whose situation is not expected to reappear without
extrinsic incentive);
- Patients who are receiving systemic steroid treatment within 3 days before the first
dose of trial drugs or any other form of immunosuppressive drugs. Notes: a.
Corticosteroids can be used to deal with adverse reactions (AEs) and serious adverse
reactions (SAEs) after period 1, and can also be used as a pre-medication for the
control chemotherapy group, as a preventive drug for the allergy/reaction of
intravenous contrast enhanced radiography, or if it is considered necessary for the
subject to use. b. Except for the subjects who are receiving steroid replacement
therapy every day. A daily dose of 5-7.5 mg of prednisone is an alternative
treatment. c. Equivalent dose of hydrocortisone treatment can also be allowed to
enter the trial if it is an alternative treatment.
- With any clinically significant active infection, including but not limited to:
active tuberculosis, infection of Human immunodeficiency virus (HIV);
- HBV DNA of patients with chronic hepatitis B virus (HBV) infection must be <100
IU/mL, and antiviral treatment should be carried out at the same time;
- Previous malignant disease within the last 5 years with the exception of post
radical resection of basal or squamous cell carcinoma of the skin or cervical
carcinoma in situ;
- Anticancer treatment within 4 weeks before the research, including but not limited
to: chemotherapy, radical radiotherapy, targeted therapy, immunotherapy, antitumor
traditional Chinese medicine/ Chinese patent medicine, transcatheter arterial
chemoembolization, Cryoablation or radiofrequency ablation of liver metastases;
- History of receiving anti-angiogenic drugs such as surufatinib, bevacizumab,
ramucirumab, aflibercept, anlotinib, apatinib, lenvatinib, sorafenib, sunitinib,
regorafenib, fruquintinib, endostatin, etc.
- History of receiving anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs directly
acting on another stimulatory or co-inhibitory T cell receptor (such as CTLA-4,
OX-40, CD137, LAG3);
- History of allergy to any component of surufatinib and envafolimab;
- Accination with live or live/attenuated viruses within 4 weeks of the first dose of
surufatinib/ envafolimab and while on trial is prohibited;
- Have major surgery, severe traumatic injuries, fracture or ulcer within 4 weeks
before treatment;
- Pregnant or lactating women;
- Participate in other clinical trials at present or within four weeks before
enrollment;
- According to the judgment of the researchers, the subject has other factors that may
lead to the forced termination of the study, such as other severe diseases
(including mental diseases) which need to be treated together, severe laboratory
abnormalities , family or social factors.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Address:
City:
Beijing
Zip:
100032
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiang Wang
Phone:
69158754
Email:
wangxiang5123@126.com
Start date:
February 2, 2023
Completion date:
February 2, 2027
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06062927
