RecruitingPhase 1Phase 2NCT05774275

The Combination of Radiotherapy, Chemotherapy and Immunotherapy in High-Risk Localized Soft Tissue Sarcoma

A Prospective Phase Ib/II Trial of Preoperative Radiotherapy Combined With Chemotherapy and Immunotherapy in High-Risk Localized Soft Tissue Sarcoma


Sponsor

Fudan University

Enrollment

52 participants

Start Date

Aug 25, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, single-center, single-arm, phase Ib/II clinical trial. The study aims to evaluate the safety and efficacy of the treatment which combines radiotherapy, chemotherapy and immunotherapy in patients with high-risk localized soft tissue sarcoma. There will be 52 patients with high-risk localized extremity and trunk soft tissue sarcoma recruited. The trail is designed as a two-stage study. In safety lead-in phase (phase Ib), using 3+3 design, 4 cycles of Doxil (37.5 mg/m2, 30 mg/m2, q3w) or doxorubicin hydrochloride (75mg/m2, q3w), Sintilimab (200mg, q3w) and radiotherapy (BED=50-60Gy (α/β=10)) will be applied. In phase II, Doxil will be applied in the recommended phase 2 dose (RP2D) according to phase Ib. And 200mg sintilimab and radiotherapy will be applied as before. The dose-limiting toxicity (DLT) in phase Ib and objective response rate (ORR) in phase Ib+Phase II will be mainly analyzed.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a combination of radiation therapy, chemotherapy, and immunotherapy for people with high-risk localized soft tissue sarcoma — a cancer of the body's connective tissues (such as fat, muscle, and blood vessels) in the limbs or trunk that is large, hard to remove, or has come back after surgery. **You may be eligible if...** - You have confirmed soft tissue sarcoma (grade 2 or 3) such as liposarcoma, leiomyosarcoma, synovial sarcoma, or similar types - Your tumor is larger than 5 cm, or it has been determined to be borderline or unresectable - The cancer is localized to the limbs or trunk (no spread to distant organs) - This is your first time with this tumor or it has recurred locally after more than 2 months of being disease-free **You may NOT be eligible if...** - Your cancer has spread to other parts of the body (distant metastases) - You have a cancer type not listed (e.g., radiation-induced angiosarcoma) - You have serious organ problems or autoimmune conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPegylated Liposomal Doxorubicin

In phase Ib: 37.5 mg/m2, 30 mg/m2, d1, q3w; In phase II: recommended phase 2 dose (RP2D), d1, q3w.

DRUGDoxorubicin

75mg/m2, d1, q3w Doxorubicin hydrochloride will be administered if subject is allergic to Doxil.

DRUGAnti-PD-1 monoclonal antibody

200 mg, d1, q3w

RADIATIONRadiotherapy

BED=50-60Gy(α/β=10); Radiation dose depends on tumor characteristics and organs at risk.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT05774275


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