Advanced Soft Tissue SarcomaNCT06062927
Geno-radiomics Based Model for Evaluation of Immunotherapy and Targeted Therapy for Advanced Soft Tissue Sarcoma
An observational study of Advanced Soft Tissue Sarcoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Soft Tissue Sarcoma
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2023to 2 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced soft tissue sarcoma receiving immunotherapy plus targeted therapy
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100032
Xiang Wang, 69158754, wangxiang5123@126.com
About this study
Official title: Geno-radiomics Based Model for Response and Prognostic Evaluation of Immunotherapy and Targeted Therapy for Advanced Soft Tissue Sarcoma
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.
- Conditions
- Advanced Soft Tissue Sarcoma
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of Geno-radiomics-based model for response evaluation of immunotherapy and targeted therapy for advanced soft tissue sarcoma
Receiver operating characteristic (ROC) curves and area under the curve (AUC) are used to evaluate the accuracy of the model
Measured: From the start of randomization to a minimum of 42 months
Secondary outcomes (1)
The accuracy of Geno-radiomics-based model for predicting prognosis of immunotherapy and targeted therapy for advanced soft tissue sarcoma
ROC curves and AUC are used to evaluate the accuracy of the model
Measured: From the start of randomization to a minimum of 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start2 Feb 2023
- Primary completion2 Feb 2026 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiang Wang, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062927
- Sponsor's protocol ID
- K2313
- Status last verified
- Sep 2023
- First submitted
- 18 Sep 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geno-radiomics Based Model for Response and Prognostic Evaluation of Immunotherapy and Targeted Therapy for Advanced Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT06062927
- Acronym / sponsor ID
- K2313
- Conditions
- Advanced Soft Tissue Sarcoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 2 Feb 2026 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced soft tissue sarcoma receiving immunotherapy plus targeted therapy
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (25 listed)
- 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%;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The accuracy of Geno-radiomics-based model for response evaluation of immunotherapy and targeted therapy for advanced soft tissue sarcoma
Time frame: From the start of randomization to a minimum of 42 months
Receiver operating characteristic (ROC) curves and area under the curve (AUC) are used to evaluate the accuracy of the model
1 secondary outcome
The accuracy of Geno-radiomics-based model for predicting prognosis of immunotherapy and targeted therapy for advanced soft tissue sarcoma
Time frame: From the start of randomization to a minimum of 42 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiang Wang principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Soft Tissue Sarcoma, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiang Wang (69158754, wangxiang5123@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of Geno-radiomics-based model for response evaluation of immunotherapy and targeted therapy for advanced soft tissue sarcoma (time frame: From the start of randomization to a minimum of 42 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.