SHR-1316 in Combination With Chemotherapy in Patients With Esophageal Squamous Cell Cancer
NCT ID: NCT03732508
Last Updated: 2018-11-06
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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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2018-11-30
2020-10-31
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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Irinotecan liposome plus SHR1316 plus fluorouracil
Irinotecan liposome
Irinotecan liposome intravenous infusion will be administered during the first day of treatment.
SHR-1316
SHR-1316 intravenous infusion will be administered during the first day of treatment.
Fluorouracil
Fluorouracil intravenous infusion will be administered during the first day of treatment.
Interventions
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Irinotecan liposome
Irinotecan liposome intravenous infusion will be administered during the first day of treatment.
SHR-1316
SHR-1316 intravenous infusion will be administered during the first day of treatment.
Fluorouracil
Fluorouracil intravenous infusion will be administered during the first day of treatment.
Eligibility Criteria
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Inclusion Criteria
2. No previous systemic anti-tumor treatment;
3. Subjects must have at least one measurable tumor lesion per RECIST 1.1;
4. ECOG: 0-1;
5. Adequate organ and bone marrow function;
Exclusion Criteria
2. Prior therapy as follow:
1. Anti-PD-1 or anti-PD-L1;
2. Any experimental drugs within 4 weeks of the first dose of study medication;
3. Received major operations or serious injuries within 4 weeks of the first dose of study medication;
4. Received last dose of anticancer therapy (including chemotherapy, radiotherapy, targeted therapy, etc.) within 4 weeks of the first dose of study medication;
3. Not recovered to ≤CTCAE 1 from adverse events (except for hair loss) due to a previously anti-tumor treatment;
4. Subjects with any active autoimmune disease or history of autoimmune disease;
5. Pregnancy or breast feeding;
18 Years
75 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jing Huang
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locations
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Cancer Institute and Hospital,Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Jing Huang
Role: primary
Other Identifiers
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IRI-SHR-1316-201
Identifier Type: -
Identifier Source: org_study_id
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