NCT06020885 - Fraction Dose Escalation of Split-course Hypofractionated Concurrent Chemoradiotherapy Following Induction Chemo-immunotherapy in Unresectable Locally Advanced Esophageal Squamous Carcinoma: a Phase I Study. | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 31, 2023

Primary Completion Date

October 30, 2025

Study Completion Date

October 30, 2025

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

RADIATION

Split-course hypo-CCRT

"Split-course hypo-CCRT is administered at the following three dose levels:~* Level 1: DT 3000cGy/10 daily fractions/300cGy in the first course, DT 2000cGy/10 daily fractions/200cGy in the second course;~* Level 2: DT 2800cGy/7 daily fractions/400cGy in the first course, DT 2200cGy/10 daily fractions/220cGy in the second course;~* Level 3: DT 2500cGy/5 daily fractions/500cGy in the first course, DT 2500cGy10 daily fractions/250cGy in the second course."

DRUG

Induction chemo-immunotherapy

All patients receive 2-3 cycles of Abraxane 260mg/m2 d1+cisplatin 60mg/m2 d1+Toripalimab 240mg d1.

DRUG

Concurrent chemotherapy

Concurrent capecitabine was administered orally at 1000mg/m2 twice daily within half an hour after meals concurrently with radiotherapy.

Trial Locations (1)

510060

Sun yat-sen University Cancer Center, Guangzhou

All Listed Sponsors

lead

Sun Yat-sen University

OTHER