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

A Prospective One-arm Study of Pegylated Liposomal Doxorubicin Combined With Anlotinib for Neoadjuvant Treatment of Locally Advanced Soft Tissue Sarcoma

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

Study Overview

• Status: Unknown
• Conditions: Stage III Adult Soft Tissue Sarcoma
• Intervention / Treatment: Drug: Anlotinib; Drug: Pegylated liposomal doxorubicin

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yong Chen, M.D.; Phone Number: 18017317571; Email: chenyong@fudan.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Chen C Yong, M.D.; Phone Number: 13917530417; Email: chenyong@fudan.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 AJCC staging of soft tissue sarcoma, or tumors that are closely related to important blood vessels and important nerves suggested by imaging data;
3. No distant transfer
4. According to the preliminary judgment of the research, patients who can improve the effect 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 and platelet 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 upper limit of normal (ULN);
10. Adequate renal function: serum creatinine ≤ upper limit of normal (ULN) or calculated creatinine 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 on the 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 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.
14. 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.

Exclusion Criteria:

1. Ewing's sarcoma, embryonic rhabdomyosarcoma, acinar rhabdomyosarcoma
2. Pregnant or breastfeeding women, or women who are fertile but have not taken contraceptive measures
3. Existing severe acute infection that has not been controlled; or having purulent or chronic 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 cured cervical 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, 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
8. 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
9. Past severe chronic skin diseases
10. People with bleeding tendency, evidence of hereditary bleeding constitution or coagulopathy
11. Have a clear history of allergy to chemotherapy drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pegylated liposomal doxorubicin + Anlotinib; 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: Anlotinib; Anlotinib; Drug: Pegylated liposomal doxorubicin; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Objective Response Rate	At the end of Cycle 3 (each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pCR rate	Pathological complete response rate	One year after the first intravenous drip
PFS	Progression free survival	6 weeks after the first intravenous drip
OS	Overall Survival	After the first intravenous drip,an average of 3 year through study completion

Collaborators and Investigators

• Sponsor: Yong Chen

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: February 18, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 18, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Doxorubicin; Liposomal doxorubicin
• Other Study ID Numbers: IRB1912212-12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No