The Combination of Radiotherapy, Chemotherapy and Immunotherapy in High-Risk Localized Soft Tissue Sarcoma
Status:
Recruiting
Trial end date:
2029-08-24
Target enrollment:
Participant gender:
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.