A Phase Ⅱ ,Open-label ,Single Institution Study to Investigate the Efficacy and Safety of Camrelizumab in Combination With Neoadjuvant Chemotherapy in the Treatment of High-risk Soft Tissue Sarcoma

Sun Yat-sen University1 site in 1 country62 target enrollmentOctober 19, 2020

ConditionsSoft Tissue Sarcoma

InterventionsCamrelizumab in Combination With Neoadjuvant Chemotherapy

DrugsCamrelizumab in Combination With Neoadjuvant Chemotherapy

Overview

Phase: Phase 2
Intervention: Camrelizumab in Combination With Neoadjuvant Chemotherapy
Conditions: Soft Tissue Sarcoma
Sponsor: Sun Yat-sen University
Enrollment: 62
Locations: 1
Primary Endpoint: Objective response rate
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a open-lable , single arm，single center, phase II clinical study. Target population is patients with high-risk Soft tissue sarcoma. Study objective is to compare the efficacy and safety of camrelizumab in combination with Liposome doxorubicin and Ifosfamide in study population in China. Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody.

Detailed Description

In this study, eligible subject will be enrolled into study arm to accept study treatment. Treatment cycles of chemotherapy will be at most 8 cycles which will be decided by investigators. Objective response rate will be the primary outcome measures.

Registry

clinicaltrials.gov

Start Date

October 19, 2020

End Date

March 19, 2024

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Jin Wang,MD

Director of bone and soft tissue

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•Age 14 to 65 year old;
•Eastern Cooperative Oncology Group performance status 0-1;
•The high-risk soft tissue sarcoma of limbs or trunk (FNCLCC grade 3 or FNCLCC grade2 but imaging evaluation showed that it was more than 50% necrosis; more than 5cm; deep tumor), including synovial sarcoma, undifferentiated pleomorphic sarcoma / malignant fibrous histiocytoma, pleomorphic rhabdomyosarcoma, round cell /Myxiod liposarcoma，Malignant peripheral nerve sheath tumors, etc;
•Patients with soft tissue sarcoma who are ready for neoadjuvant chemotherapy need to meet the following conditions:
•According to the evaluation, the patients who received neoadjuvant chemotherapy can achieve standard resection of tumor
•If important structures (blood vessels and nerves) are involved, radical operation cannot be performed
•Having measurable lesion according to RECIST 1.1
•Life expectancy \>3 months
•Patients must have adequate organ function
•Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 120 days after last study drug administration. Women of childbearing potential must have a negative pregnancy test ≤ 72 hours prior to Day 1 of study

Exclusion Criteria

•pregnant or lactating women
•Known history of hypersensitivity to any components of the camrelizumab formulation, or other antibody formulation.
•Active central nervous system (CNS) metastases with clinical symptoms , including cerebral edema, steroid requirement, or progressive disease.
•Patients with other malignant tumor within 5 years , except cured skin basal cell carcinoma, cervical carcinoma and Papillary carcinoma of thyroid.
•Clinically significant cardiovascular diseases
•Have received any of the following treatments：
•Patients have had prior treatment with PD-1/PD-L1 or CTLA-4 antagonists.
•Received any study drug within 4 weeks prior to the first study drug administration.
•Enroll in another clinical study, unless it is an observational (non-interventional) clinical study or an intervention follow-up study.
•Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids.