A Phase II Study of CRT Combined With QL1706 in ESCC Patients
NCT ID: NCT05490719
Last Updated: 2024-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
39 participants
INTERVENTIONAL
2022-08-01
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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QL1706 plus Chemotherapy and Radiotherapy
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.
QL1706
QL1706 is a humanized anti-PD1 IgG4 and anti-CTLA-4 IgG4 antibody.
Interventions
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QL1706
QL1706 is a humanized anti-PD1 IgG4 and anti-CTLA-4 IgG4 antibody.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. age:18-75 years, male or female.
3. Histologically confirmed Advanced Unresectable Esophageal Squamous Cell Carcinomas,unresectable of clinical stage II-IVa patients (include unresectable,or surgical contraindication or refuse surgery)(According to AJCC 8th Edition stage , Pre-treatment clinical stage cT1N2-3M0,cT2-4bN0-3M0.
4. At least 1 measurable target lesion and/or unmeasurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1).
Exclusion Criteria
2. Previous history of fistula caused by primary tumor infiltration.
3. a high risk of gastrointestinal bleeding, esophageal fistula or esophageal perforation.
4. Subjects with poor nutritional status and weight loss of ≥ 10% in the first 2 months of screening have no significant improvement after nursing intervention.
5. Major surgery or serious trauma within 4 weeks before the first use of the study drug.
18 Years
75 Years
ALL
No
Sponsors
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Tianjin Medical University Cancer Institute and Hospital
OTHER
Responsible Party
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Locations
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Tianjin cancer hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Qingsong Pang
Role: primary
Other Identifiers
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QL1706-IIT-02
Identifier Type: -
Identifier Source: org_study_id
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