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NOT YET RECRUITING
NCT06136988
PHASE1/PHASE2

A Study of Docetaxel for Injection (Albumin-bound) and SG001 in Combination With Cisplatin and Simultaneous Radiotherapy for Locally Advanced Unresectable Esophageal Squamous Carcinoma.

Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

Summary

The study is a multicenter, open-label, phase Ib/II study to evaluate the efficacy and safety of docetaxel for injection (albumin-bound) (HB1801) and SG001 in combination with cisplatin and simultaneous radiotherapy versus paclitaxel in combination with cisplatin and simultaneous radiotherapy for locally advanced unresectable esophageal squamous carcinoma.

Official title: A Multicenter, Open-label, Phase Ib/II Study of Docetaxel for Injection (Albumin-bound) and SG001 in Combination With Cisplatin and Simultaneous Radiotherapy Versus Paclitaxel in Combination With Cisplatin and Simultaneous Radiotherapy for Locally Advanced Unresectable Esophageal Squamous Carcinoma.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

129

Start Date

2023-12

Completion Date

2028-04

Last Updated

2023-11-18

Healthy Volunteers

No

Interventions

DRUG

Docetaxel for Injection (Albumin-bound)

Docetaxel for Injection (Albumin-bound) 60 or 75 mg/m\^2, Intravenous infusion, Q3W

DRUG

SG001

Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection, 360 mg, Intravenous infusion, Q3W

DRUG

Cisplatin for injection

Cisplatin for injection, 25 mg/m\^2, Intravenous infusion, D1-D3, Q3W

DRUG

Paclitaxel

Paclitaxel 135 mg/m\^2, Intravenous infusion, Q3W

RADIATION

Simultaneous Radiotherapy

Radiotherapy (28×1.8Gy)

Locations (2)

Shandong Tumor Hospital

Jinan, Shandong, China

Tianjin cancer institute &hospital

Tianjin, Tianjin Municipality, China