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Trials in Progress

(P 534) NEOADJUVANT CHEMOTHERAPY COMBINED WITH TARGETED TREATMENT IN HIGH-RISK RETROPERITONEAL SARCOMA – A PROSPECTIVE NON-RANDOMIZED CONTROLLED MULTI-CENTERED STUDY ALL ACROSS CHINA

Location: The Liffey, Level 1

    Author(s)

  • Jun Chen, MD, PhD

    Associate Chief Surgeon
    Retroperitoneal Tumours Centre, Peking University International Hospital, Beijing, China
    Beijing, Beijing, China (People's Republic)

    • Co-Author(s)

  • HT

    Hanxing Tong, MD, PhD

    Shanghai Zhongshan Hospital
    Shanghai, Shanghai, China (People's Republic)

  • XW

    Xing Wei, MD, PhD

    Department of Medical Oncology, Peking University International Hospital
    Beijing, Beijing, China (People's Republic)

  • Xx

    Xuehai xie, MD, PhD

    Peking University First Hospital
    Beijing, Beijing, China (People's Republic)

  • LT

    Lantian Tian, MD, PhD

    The Affiliated Hospital of Qingdao University
    Qingdao, Shandong, China (People's Republic)

  • ST

    Siwei Tan, MD, PhD

    Beijing Friendship Hospital
    Beijing, Beijing, China (People's Republic)

  • Hongqiang Zhang, MB

    MB
    Fudan University Shanghai Cancer Center Minhang Branch Hospital
    Shanghai, Shanghai, China (People's Republic)

  • WC

    Weida Chen, MD, MD

    Department of Retroperitoneal Tumor Surgery, Peking University International Hospital
    Beijing, Beijing, China (People's Republic)

  • MH

    Mei Huang, RN

    Department of Retroperitoneal Tumor Surgery, Peking University International Hospital
    Beijing, Beijing, China (People's Republic)

  • SW

    Shufeng Wang, MD, PhD

    First Affiliated Hospital Xi'an Jiaotong University
    Xian, Shaanxi, China (People's Republic)

  • WL

    Wenjie Li, MD

    Department of Retroperitoneal Tumor Surgery, Peking University International Hospital
    Beijing, Beijing, China (People's Republic)

  • YZ

    Yuhong Zhou, MD, PhD

    Shanghai Zhongshan Hospital
    Shanghai, Shanghai, China (People's Republic)

  • ZZ

    Zhongtao Zhang, MD, PhD

    Beijing Friendship Hospital
    Beijing, Beijing, China (People's Republic)

  • CL

    Chenghua Luo, MD, Postgraduate/PhD

    Chief
    Retroperitoneal Tumours Centre, Peking University International Hospital, Beijing, China
    Beijing, California, United States

Objective: The role of neoadjuvant therapy in the retroperitoneal sarcoma area remains uncertain. The goal of this clinical trial is to explore the potential survival benefits of neoadjuvant chemotherapy combined with target treatments followed by curative-intent surgery in patients with primary high-risk/grade retroperitoneal sarcoma.

Methods: It is a prospective non-randomized controlled multicentered study. It was approved by Peking University International Hospital Institution Review Board(2022-KY-0070-01) and registered in clinicaltrials.gov(NCT05844813). Patients who meet the inclusion and exclusion criteria will be allocated either into the Surgery-only Group(Group S) or the Neoadjuvant therapy group(Group N) after informed consent is acquired and the pathological confirmation of diagnosis through preoperative biopsy. Patients in Group S will undergo surgeries directly while in the neoadjuvant therapy group, patients will receive neoadjuvant chemotherapy combined with target treatment for three circles followed by the curative-intent surgeries. The drugs in neoadjuvant therapy include pegylated liposomal doxorubicin (PLD), ifosfamide(I) as well as anlotinib(A), a novel multi-targeting tyrosine kinase inhibitor. The sample size is 102 with 51 subjects in each group, calculated through R language. The primary endpoint is 3-year progression-free survival(PFS). Second endpoints include overall survival(OS), local recurrence-free survival(LRFS), and distant recurrence-free survival(DRFS) in 1,3,5 -year durations. The safety and toxicity of neoadjuvant therapy, as well as postoperative morbidities and mortalities, are also collected and evaluated in two groups. Survival outcomes are compared and calculated using the Kaplan-Meier method. Prognostic factors were analyzed through the Cox proportional hazard model. A p-value less than 0.05 was considered statistical significance.

Results: N/A（Not Applicable）

Conclusion: N/A（Not Applicable）