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Surufatinib and Envafolimab as Second or More-line Therapy in Advanced Soft Tissue Sarcoma Patients | Clinical Trials | Clareo Health

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Surufatinib and Envafolimab as Second or More-line Therapy in Advanced Soft Tissue Sarcoma Patients

Surufatinib Combined With Envafolimab Followed by Surufatinib as Second or More - Line Therapy for Advanced Soft Tissue Sarcoma in a Single-arm, Phase II Study

NCT05722977•Peking Union Medical College Hospital

View on ClinicalTrials.gov

Summary

In this study, we investigated the efficacy and safty of surufatinib combined with envafolimab followed by surufatinib as second or more - line therapy in advanced soft tissue sarcoma patients. Patients who have failed at least the first-line therapy and have progressive disease or cannot tolerate within 6 months before enrollment will be treated with surufatinib combined with envafolimab.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female subjects aged from 18 to 75 years old;
•2. 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;
•3. Patients who have at least failed first-line treatment and had a disease progression within 6 months or can not tolerate the treatment. Notes: if the cumulative dose of anthracycline drugs reach threshold according to the guideline of Chinese Society of Clinical Oncology(CSCO) published in 2020, it will be regarded as intolerable;
•4. 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;
•5. Newly obtained or archived tumor tissue samples can be provided;
•6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2 at trial entry;
•7. Estimated life expectancy of more than 12 weeks;
•8. Adequate organ functions defined by the protocol;
•9. 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;
•10. Able to comply with the research protocol and follow-up process for treatment and follow-up;
+1 more criteria

Exclusion Criteria

•1. 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.
•2. 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.
•3. 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;
•4. Hypertension that cannot be controlled stably by drugs, which is defined as: systolic blood pressure\>140mmHg or diastolic blood pressure\>90mmHg;
•5. 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%
•6. QTc interval ≥ 480 milliseconds (ms) on electrocardiogram (ECG);
•7. 24-h urinary protein level \>1.0g/day;
•8. Serum potassium, calcium (after correction for ionic or albumin-bound type) or magnesium are beyond the normal range and have clinical significance.
•9. 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;
•10. With factors affecting oral drug administration: dysphagia, post-gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc
+15 more criteria

Key Dates

Start Date

February 2, 2023

Primary Completion Date

February 2, 2026

Completion Date

February 2, 2027

Last Updated

February 10, 2023

Enrollment

ESTIMATED participants

Conditions

Efficacy and Safety of Surufatinib Combined With Envafolimab as Second or More-line Therapy in Advanced Soft Tissue Sarcoma Patients

Interventions

Surufatinib + envafolimab

DRUG

Contacts

Xiang Wang

CONTACT

69158754 wangxiang@pumch.cn