Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Antibodies

Antibodies, Monoclonal

Cisplatin

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

SG001 360 mg, Intravenous infusion, D1, Q3W, up to approximately 2 years ; Docetaxel for Injection (Albumin-bound) (HB1801), Intravenous infusion, D1, Q3W, 60 or 75 mg/m\^2, up to 2 cycles; cisplatin for injection 25 mg/m\^2, D1-D3, Q3W, up to 2 cycles; radiotherapy (28×1.8Gy).All treatments will be administered until disease progression or intolerable toxicity.

Paclitaxel 135 mg/m\^2, Intravenous infusion, D1, Q3W; cisplatin for injection 25 mg/m\^2, D1-D3, Q3W, radiotherapy (28×1.8Gy). No other systemic antineoplastic therapy is allowed until disease progression, optimal supportive care and local palliative care are allowed.

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

Docetaxel for Injection (Albumin-bound)

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

SG001

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

Cisplatin for injection

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

Simultaneous Radiotherapy

Clinical Trials Information Group officer

Jin ming Yu

Qing song Pang

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.

This study will be conducted in two stages. The first stage (Phase Ib) is a dose-escalation study designed to determine the safety and the recommended Phase 2 dose (RP2D) of HB1801 and SG001 in combination with cisplatin and simultaneous radiotherapy for locally advanced unresectable esophageal squamous carcinoma. Patients will be assigned to receive sequentially higher doses of HB1801 once every three weeks (a Cycle) by intravenous infusion, starting at a dose of 60 mg/m\^2. The second stage (Phase II) is a study to evaluate the efficacy and safety of 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. Regular visits and imaging examinations will be conducted to compare the efficacy and safety of the two groups.

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

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.

Spots Global Cancer Trial Database for locally advanced unresectable esophageal squamous carcinoma