Enrolling by invitationNCT05844813NATARSUpdated May 12, 2023

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

A Phase 4 interventional study of Doxorubicin+Ifosfamide+Anlotinib(AI+A) and Radical Surgery in Retroperitoneal Sarcoma, sponsored by Peking University International Hospital. Enrolling by invitation at 6 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-05-12.

Sponsored by Peking University International Hospital · Phase 4, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by Nov 2025, 11 months ago, but the record still lists the study as enrolling by invitation.
Registered 5 months after the study started (first participant enrolled Nov 2022, registered Apr 2023).

Phase: Phase 4
Study type: Interventional
Enrollment: 102
Allocation: Non-randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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.

Conditions studied

Retroperitoneal Sarcoma

Browse trials for

Sarcoma 1,667

Keywords

Retroperitoneal Sarcoma
Neoadjuvant therapy
Target therapy
Survival

In context

Sarcoma

1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.

This study's planned enrollment of 102 is above the median of 40 across 1,283 interventional studies indexed under Sarcoma.

Browse Sarcoma studies →

Lead sponsor

Peking University International Hospital is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Histologically proven primary high-risk Retroperitoneal sarcoma(RPS) (Including Dedifferentiated liposarcoma (DDLPS), leiomyosarcoma(LMS), Undifferentiated pleomorphic sarcoma(UPS), Solitary fibrous tumor(SFT)).
Primary localized RPS without histories of surgical resection, chemo- or radio-therapy, targeted therapy. Patients who underwent laparotomy with biopsy only will also be considered as primary cases.
Without histories of second malignant tumors.
In DDLPS
- Diagnosis should be confirmed based on MDM2(Mouse double minute 2 homolog) and CDK4(Cyclin-dependent kinase 4) expression on IHC (immunohistochemistry), while MDM2 amplification in the Fish test is highly recommended.
- All grade 2-3 DDLPS can be included.
In LMS
- All grades of LMS can be included.
- Tumor size ≥10cm
In UPS or SFT
- All grades of UPS can be included.
- High-risk SFT with a score ≥6 in 'Risk stratification of SFT for development of metastasis' introduced in The 5th edition of the WHO(World Health Organization) Soft tissue sarcoma classification.
Sarcoma without protruding across the diaphragm
Possibility of R0/R1 resection evaluated through preoperative MDT(multi-disciplinary team) discussion
No multi-organ or system dysfunction/failure or patients with slight dysfunction of organ/system could be easily recovered
Tolerable of chemotherapy and surgery through MDT evaluation and tests.
American Society of Anesthesiologist (ASA) ≤3
Fully understand the informs and consent to participate in the study.

Exclusion criteria

Exclusion Criteria:

Sarcoma confirmed originating from the GI tract, uterus, or urinal tract.
Patients included in the study through preoperative biopsy or MDT discussion, with WDLPS, grade 1 LPS, or other types of tumors not mentioned in the Inclusion criteria evaluating through final pathological findings.
Sarcoma protruded into the chest cavity evaluated through preoperative imaging or surgical reports.
Metastasis confirmed pathologically or highly suspicious metastatic lesions through radiological findings, PET-CT(Positron emission tomography) is highly recommended, MDT discussion and evaluation are needed.
Histories of administration of Anthracyclines, Ifosfamide, and targeted agents.
Severe contradiction to surgery and chemotherapies, including persistent myelosuppression, myocardial/cerebral/pulmonary infarction, uncontrolled cardiac arrhythmia, etc within the last 6 months
Indication of severe infection or undergoing surgeries with high-risk hemorrhages in one month.
Persistent one or more organ or system dysfunctions, could not be recovered prior to the study.
Female patients who are pregnant or breastfeeding or female and male patients of reproductive potential who are not willing to employ effective birth control methods.
Patients with psychological conditions

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 102 participants (estimated)

Study arms

Experimental
The Neoadjuvant Therapy Group
Neoadjuvant chemotherapy + Target therapy+ Radical resectional Surgery Drugs: Doxorubicin（PLD） 40mg/㎡ d1, Ifosfamide 1g/㎡ d1-5, Anlotinib10mg d1-14 Q3weeks \* 3 Circles, Watch-Wait 4-6 weeks
Drug: Doxorubicin+Ifosfamide+Anlotinib(AI+A) · Procedure: Radical Surgery
Active comparator
The Surgery only Group
Procedure: Radical resectional surgery
Procedure: Radical Surgery

Interventions

DrugDoxorubicin+Ifosfamide+Anlotinib(AI+A)
Doxorubicin（PLD） 40mg/㎡ d1, Ifosfamide（I） 1g/㎡ d1-5, Anlotinib（A）10mg d1-14 Q3weeks \* 3 Circles
ProcedureRadical Surgery
Radical sarcoma resectional surgery

What researchers measure

Primary outcomes

3-year Progression Free Survival(PFS)
Progression free survival will be measured from the date of surgery to the date of progression or death, whichever occurs first.
Time frame: 3 years after first patient enrolled in

Secondary outcomes

1-year PFS
Progression free survival will be measured from the date of surgery to the date of progression or death, whichever occurs first.
Time frame: 1year after first patient enrolled in.
1 year Overall survival(OS)
OS will be measured from the date of surgery to the date of death, whatever the causes of death.
Time frame: 1year after first patient enrolled in
3-year OS
OS will be measured from the date of surgery to the date of death, whatever the causes of death.
Time frame: 3 years after first patient enrolled in
5-year PFS
Progression free survival will be measured from the date of surgery to the date of progression or death, whichever occurs first.
Time frame: 5 years after first patient enrolled in.
5-year OS
OS will be measured from the date of surgery to the date of death, whatever the causes of death.
Time frame: 5 years after first patient enrolled in
Safety and toxicity of neoadjuvant therapy
Safety and toxicity will be evaluated through blood tests, echocardiography, ECG, etc.
Time frame: 1-d, 7-d after the first date of each neoadjuvant therapy session.
Postoperative morbidities
Operative outcomes including morbidities will be collected and compared in two groups.
Time frame: 30-d, 90-d, 1-year separately after the date of surgery.

Study locations

6 sites

Beijing Friendship Hospital
Beijing, Beijing, China
Peking University First Hospital
Beijing, Beijing, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Shanghai Cancer Hospital, Minhang Branch
Shanghai, Shanghai, China
Shanghai Zhongshan Hospital
Shanghai, Shanghai, China
First Affiliated Hospital Xi'an Jiaotong University
Xi'an, Shanxi, China

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05844813
Lead sponsor: Peking University International Hospital
Collaborators: Shanghai Zhongshan Hospital, The Affiliated Hospital of Qingdao University, Peking University First Hospital, Shanghai Cancer Hospital, China, First Affiliated Hospital Xi'an Jiaotong University, Beijing Friendship Hospital
Responsible party: Jun Chen (MD, Peking University International Hospital) — Principal investigator
First posted: May 6, 2023
Start date: Nov 1, 2022
Primary completion: Nov 1, 2025 (estimated)
Completion: Nov 1, 2027 (estimated)
Last update: May 12, 2023

Study contacts

Chenghua Luo, MD, PhD

study chair · Peking University International Hospital

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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