Last updated: February 18, 2021
Sponsor: Yong Chen
Overall Status: Active - Recruiting
Phase
2
Condition
Sarcoma
Treatment
N/AClinical Study ID
NCT04765228
IRB1912212-12
Ages 14-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with soft tissue sarcoma confirmed by histopathology;
- Patients with soft tissue sarcoma judged to be stage IIB/III according to the AJCCstaging of soft tissue sarcoma, or tumors that are closely related to important bloodvessels and important nerves suggested by imaging data;
- No distant transfer
- According to the preliminary judgment of the research, patients who can improve theeffect of surgery by neoadjuvant treatment;
- Male or female, aged ≥14 years old and ≤75 years old;
- ECOG score ≤ 2;
- The expected survival period is ≥3 months;
- Adequate hematopoietic function: absolute neutrophil count (ANC) ≥ 1.5×109/L andplatelet count ≥ 80×109/L and hemoglobin ≥ 9 g/dL;
- Sufficient liver function: total bilirubin ≤ upper limit of normal (ULN); AST and ALT ≤ 1.5 times the upper limit of normal (ULN); alkaline phosphatase ≤ 5 times the upperlimit of normal (ULN);
- Adequate renal function: serum creatinine ≤ upper limit of normal (ULN) or calculatedcreatinine clearance ≥ 60 mL/min;
- Visceral function: LVEF≥50%, the New York Society of Visceral Disease Association (NYHA) has a functional classification of I and II, and there is no unhealed wound onthe body;
- Sign the informed consent form.
- Women should agree to use contraceptive measures (such as intrauterine device (IUD),contraceptives or condoms) during the study period and within 6 months after the endof the study; serum or urine pregnancy within 7 days before study entry The test isnegative and must be a non-lactating patient; men should agree to patients who mustuse contraception during the study period and within 6 months after the end of thestudy period.
- The patient voluntarily joined the study, signed an informed consent form, had goodcompliance, and was able to be followed up by the trial staff.
Exclusion
Exclusion Criteria:
- Ewing's sarcoma, embryonic rhabdomyosarcoma, acinar rhabdomyosarcoma
- Pregnant or breastfeeding women, or women who are fertile but have not takencontraceptive measures
- Existing severe acute infection that has not been controlled; or having purulent orchronic infection, and the wound is protracted
- Active hepatitis B or C
- Have a history of other tumors within 5 years before treatment, except for curedcervical carcinoma in situ or skin basal cell carcinoma
- Those who have participated in other drug clinical trials within 4 weeks
- Patients with pre-existing severe heart disease, including: congestive heart failure,uncontrollable high-risk arrhythmia, unstable angina, myocardial infarction, severeheart valve disease and refractory hypertension, ventricular tachycardia, ventricular,Patients with atrial fibrillation, second-degree type II or third-degreeatrioventricular block, myocardial infarction within 1 year, congestive heart failure,symptomatic coronary heart disease requiring medication
- People with uncontrollable neurological or mental diseases or mental disorders, poorcompliance, unable to cooperate and describe the treatment response; primary braintumors or central nerve metastases have not been controlled, and have obviousintracranial hypertension or neuropsychiatry Symptoms
- Past severe chronic skin diseases
- People with bleeding tendency, evidence of hereditary bleeding constitution orcoagulopathy
- Have a clear history of allergy to chemotherapy drugs
Study Design
Total Participants: 45
Study Start date:
April 01, 2020
Estimated Completion Date:
December 31, 2022
Study Description
Connect with a study center
Fudan University Shanghai Cancer Center
Shanghai, Shanghai 200000
ChinaActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.