A Phase 1/2 interventional study of Docetaxel for Injection (Albumin-bound) and SG001 in Locally Advanced Unresectable Esophageal Squamous Carcinoma, sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Phase 1/2, Interventional, and Treatment
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 129 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →CSPC ZhongQi Pharmaceutical Technology Co., Ltd. is the lead sponsor of 161 studies on the registry; 45 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Vital organ function within 7 days prior to first dose, meeting the following criteria (no blood transfusions, no use of human granulocyte colony-stimulating factor (G-CSF), thrombopoietin (TPO), and erythropoietin (EPO) within 14 days prior to the first dose):
Exclusion Criteria:
History of severe cardiovascular disease within 6 months prior to the first dose, including but not limited to:
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.
Drug: Docetaxel for Injection (Albumin-bound) · Drug: SG001 · Drug: Cisplatin for injection · Radiation: Simultaneous Radiotherapy
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.
Drug: Cisplatin for injection · Drug: Paclitaxel · Radiation: Simultaneous Radiotherapy
Docetaxel for Injection (Albumin-bound) 60 or 75 mg/m\^2, Intravenous infusion, Q3W
Also known as: HB1801
Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection, 360 mg, Intravenous infusion, Q3W
Also known as: Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection
Cisplatin for injection, 25 mg/m\^2, Intravenous infusion, D1-D3, Q3W
Paclitaxel 135 mg/m\^2, Intravenous infusion, Q3W
Radiotherapy (28×1.8Gy)
Dose-limiting toxicity (DLT)
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Determine the recommended Phase 2 dose (RP2D) of Docetaxel for Injection (Albumin-bound)
Time frame: At the end of Cycle 2 (each cycle is 21 days)
Incidence and frequency of adverse events (AE) and serious adverse events (SAE) in Phase Ib
Time frame: up to 4 years
PFS as determined by the investigator according to RECIST 1.1 in Phase Ⅱ
Time frame: up to 4 years
Objective remission rate (ORR)
Time frame: up to 4 years
Disease control rate (DCR)
Time frame: up to 4 years
Duration of remission (DOR)
Time frame: up to 4 years
Progression-free survival (PFS)
Time frame: up to 4 years
Overall survival (OS)
Time frame: up to 4 years
Incidence of SG001 antidrug antibodies and neutralizing antibodies (if applicable)
Time frame: up to 4 years
Incidence and frequency of adverse events (AE) and serious adverse events (SAE) in Phase Ⅱ
Time frame: up to 4 years
Total docetaxel concentration in plasma and free docetaxel concentration
Time frame: up to 4 years
SG001 concentration in serum
Time frame: up to 4 years
To evaluate the correlation between PD-L1 expression and efficacy in tumor tissues
Time frame: up to 4 years
This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.