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

NCT06136988 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2023-11-18

No results posted yet for this study

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.

Conditions

  • Locally Advanced Unresectable Esophageal Squamous Carcinoma

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)

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-31
Primary Completion
2027-04-30
Completion
2028-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06136988 on ClinicalTrials.gov