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

NCT04765228 | Unknown Phase 2 DMC

• 1 other identifier: IRB1912212-12
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stage III Adult Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective Response Rate

  At the end of Cycle 3 (each cycle is 21 days)

Secondary Outcomes (3)

• pCR rate

  One year after the first intravenous drip

• PFS

  6 weeks after the first intravenous drip

• OS

  After the first intravenous drip,an average of 3 year through study completion

Study Arms (1)

Pegylated liposomal doxorubicin + Anlotinib

EXPERIMENTAL

Pegylated liposomal doxorubicin 50mg/m2 intravenous infusion on the first day + Anlotinib 12mg/d orally, medication on days 8-21, one cycle every 21 days, 2\~4 cycles

Drug: Pegylated liposomal doxorubicin; Drug: Anlotinib

Interventions

Pegylated liposomal doxorubicin DRUG

Pegylated liposomal doxorubicin 50mg/m2 intravenous infusion on the first day + Anlotinib 12mg/d orally, medication on days 8-21, one cycle every 21 days, 2\~4 cycles

Pegylated liposomal doxorubicin + Anlotinib

Anlotinib DRUG

Anlotinib

Pegylated liposomal doxorubicin + Anlotinib

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with soft tissue sarcoma confirmed by histopathology;
• Patients with soft tissue sarcoma judged to be stage IIB/III according to the AJCC staging of soft tissue sarcoma, or tumors that are closely related to important blood vessels and important nerves suggested by imaging data;
• No distant transfer
• According to the preliminary judgment of the research, patients who can improve the effect 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 and platelet 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 upper limit of normal (ULN);
• Adequate renal function: serum creatinine ≤ upper limit of normal (ULN) or calculated creatinine 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 on the 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 end of the study; serum or urine pregnancy within 7 days before study entry The test is negative and must be a non-lactating patient; men should agree to patients who must use contraception during the study period and within 6 months after the end of the study period.
• The patient voluntarily joined the study, signed an informed consent form, had good compliance, and was able to be followed up by the trial staff.

You may not qualify if:

• Ewing's sarcoma, embryonic rhabdomyosarcoma, acinar rhabdomyosarcoma
• Pregnant or breastfeeding women, or women who are fertile but have not taken contraceptive measures
• Existing severe acute infection that has not been controlled; or having purulent or chronic infection, and the wound is protracted
• Active hepatitis B or C
• Have a history of other tumors within 5 years before treatment, except for cured cervical 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, severe heart valve disease and refractory hypertension, ventricular tachycardia, ventricular, Patients with atrial fibrillation, second-degree type II or third-degree atrioventricular 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, poor compliance, unable to cooperate and describe the treatment response; primary brain tumors or central nerve metastases have not been controlled, and have obvious intracranial hypertension or neuropsychiatry Symptoms
• Past severe chronic skin diseases
• People with bleeding tendency, evidence of hereditary bleeding constitution or coagulopathy
• Have a clear history of allergy to chemotherapy drugs

Sponsors & Collaborators

• Yong Chen: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

liposomal doxorubicin; anlotinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Yong Chen, M.D.

CONTACT

18017317571; chenyong@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: February 21, 2021
• Study Start: April 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

CN (1)