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ENROLLING BY INVITATION
NCT05844813
PHASE4

Neoadjuvant Chemotherapy Combined With Targeted Treatment in High-risk Retroperitoneal Sarcoma

Sponsor: Peking University International Hospital

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to explore the potential survival benefits of neoadjuvant chemotherapy combined with target treatments followed by radical surgery in patients with primary high-risk/grade retroperitoneal sarcoma. The main questions it aims to answer are: * Whether the 1,3-year progression-free survival time(PFS) is prolonged in the neoadjuvant therapy group, compared with the surgery-only group. * The Overall survival time in the two groups. * The safety and tolerance in the neoadjuvant therapy group. Participants will be allocated into two groups once they meet the inclusion criteria. * Surgery-only Group: Patients will directly undergo surgeries after the confirmation of diagnosis through pre-operative biopsy. * Neoadjuvant therapy group: Patients will receive the neoadjuvant chemotherapy combined with target treatment for three circles before the following sarcoma resectional surgeries.

Official title: Neoadjuvant Chemotherapy Combined With Targeted Treatment in High-risk Retroperitoneal Sarcoma-- A Nationwide Multicentered Prospective Controlled Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

102

Start Date

2022-11-01

Completion Date

2027-11-01

Last Updated

2023-05-12

Healthy Volunteers

No

Interventions

DRUG

Doxorubicin+Ifosfamide+Anlotinib(AI+A)

Doxorubicin(PLD) 40mg/㎡ d1, Ifosfamide(I) 1g/㎡ d1-5, Anlotinib(A)10mg d1-14 Q3weeks \* 3 Circles

PROCEDURE

Radical Surgery

Radical sarcoma resectional surgery

Locations (6)

Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Peking University First Hospital

Beijing, Beijing Municipality, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Shanghai Cancer Hospital, Minhang Branch

Shanghai, Shanghai Municipality, China

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, China

First Affiliated Hospital Xi'an Jiaotong University

Xi’an, Shanxi, China