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RECRUITING
NCT05774275
PHASE1/PHASE2

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

Sponsor: Fudan University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2022-08-25

Completion Date

2029-08-24

Last Updated

2023-03-17

Healthy Volunteers

No

Interventions

DRUG

Pegylated Liposomal Doxorubicin

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

DRUG

Doxorubicin

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

DRUG

Anti-PD-1 monoclonal antibody

200 mg, d1, q3w

RADIATION

Radiotherapy

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