Pegylated Liposomal Doxorubicin Combined With Anlotinib for Neoadjuvant Treatment of Soft Tissue Sarcoma

Last updated: February 18, 2021
Sponsor: Yong Chen
Overall Status: Active - Recruiting

Phase

2

Condition

Sarcoma

Treatment

N/A

Clinical Study ID

NCT04765228
IRB1912212-12
  • Ages 14-75
  • All Genders

Study Summary

A prospective one-arm study of pegylated liposomal doxorubicin combined with anlotinib for neoadjuvant treatment of locally advanced soft tissue sarcoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with soft tissue sarcoma confirmed by histopathology;
  2. 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;
  3. No distant transfer
  4. According to the preliminary judgment of the research, patients who can improve theeffect of surgery by neoadjuvant treatment;
  5. Male or female, aged ≥14 years old and ≤75 years old;
  6. ECOG score ≤ 2;
  7. The expected survival period is ≥3 months;
  8. Adequate hematopoietic function: absolute neutrophil count (ANC) ≥ 1.5×109/L andplatelet count ≥ 80×109/L and hemoglobin ≥ 9 g/dL;
  9. 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);
  10. Adequate renal function: serum creatinine ≤ upper limit of normal (ULN) or calculatedcreatinine clearance ≥ 60 mL/min;
  11. 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;
  12. Sign the informed consent form.
  13. 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.
  14. 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:

  1. Ewing's sarcoma, embryonic rhabdomyosarcoma, acinar rhabdomyosarcoma
  2. Pregnant or breastfeeding women, or women who are fertile but have not takencontraceptive measures
  3. Existing severe acute infection that has not been controlled; or having purulent orchronic infection, and the wound is protracted
  4. Active hepatitis B or C
  5. Have a history of other tumors within 5 years before treatment, except for curedcervical carcinoma in situ or skin basal cell carcinoma
  6. Those who have participated in other drug clinical trials within 4 weeks
  7. 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
  8. 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
  9. Past severe chronic skin diseases
  10. People with bleeding tendency, evidence of hereditary bleeding constitution orcoagulopathy
  11. 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

Tumor angiogenesis is very important in the occurrence and development of soft tissue sarcoma. The current clinical studies of molecularly targeted drugs are focused on the advanced treatment stage of soft tissue sarcoma. Anti-angiogenic drugs are not yet available in the neoadjuvant treatment stage of soft tissue sarcoma. Strong evidence. Therefore, this study aimed to evaluate the safety and effectiveness of pegylated doxorubicin liposomes combined with the anti-angiogenic drug Anlotinib for neoadjuvant treatment of patients with soft tissue sarcoma.

Connect with a study center

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai 200000
    China

    Active - Recruiting

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