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This is a single arm, multi-center Phase II Study. This clinical study is an investigator-initiated clinical trial(IIT). The objective of this study is to evaluate the efficacy and safety of Chemoradiationtherapy combined with QL1706 (anti-CTLA-4 and PD-1 antibody) in patients with unresectable locally advanced esophageal squamous cell carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL1706 plus Chemotherapy and Radiotherapy | Experimental | Radiotherapy: Total 50.4Gy/28 fraction ,1.8Gy per time,5 fractions per week. QL1706 will be administered at a dose of 5 mg/kg intravenously (IV), every 3 weeks, until progressive disease or intolerable or other reasons according to the criteria for termination of treatment). QL1706 will be administered up to 1 year. Chemotherapy: Taxol 135 mg/m2, days 1, 22; Cisplatin 25 mg/m2, day 1-3, day 22-24. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL1706 | Drug | QL1706 is a humanized anti-PD1 IgG4 and anti-CTLA-4 IgG4 antibody. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS assessed by investigators | Progression-free survival assessed by investigators | Up to approximately 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall survival | 1year and 3years |
| ORR | Objective Response Rate,Complete Response plus Partial Response | Up to approximately 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingsong Pang | Contact | 0862223340123 | 1121 | pangqingsong2013@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin cancer hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41623855 | Derived | Zhang W, Zhang T, Chen X, Li J, Gao L, Jiang S, Wang Y, Zheng Z, Dong J, Li Z, Zhao G, Cao F, Bai N, Wang P, Yan C, Pang Q. Iparomlimab and tuvonralimab (QL1706) combined definitive chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma (QL1706-IIT-02): a single arm, phase 2 trial. EClinicalMedicine. 2026 Jan 21;92:103758. doi: 10.1016/j.eclinm.2026.103758. eCollection 2026 Feb. |
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| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| D004938 | Esophageal Neoplasms |
| C563326 | Diabetes Mellitus, Insulin-Dependent, 12 |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D011827 | Radiation |
| D017239 | Paclitaxel |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
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| DoR | Duration of Response | Up to approximately 2 years |
| The rates and severity of Adverse Events, Serious Adverse Events | The rates and severity of Adverse Events, Serious Adverse Events | Through study completion, up to approximately 2 years |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D006840 |
| Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |