SHR-1701 in Combination With Famitinib in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
NCT ID: NCT05020925
Last Updated: 2021-08-25
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
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2021-09-30
2024-02-29
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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SHR-1701 plus Famitinib
SHR-1701+Famitinib for R/M NPC failure after platinum-based chemotherapy and anti PD-1/PD-L1 antibody therapy
SHR-1701
Intravenous (IV) on Day 1 of each cycle
Famitinib
Famitinib, po, qd
Interventions
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SHR-1701
Intravenous (IV) on Day 1 of each cycle
Famitinib
Famitinib, po, qd
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects failure after platinum-based chemotherapy and anti-PD-1/PD-L1 antibody therapy;
* Able and willing to provide signed informed consent form, and able to comply with all procedures.
* Life expectancy \>= 12 weeks as judged by the Investigator.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry.
* Disease must be measurable with at least 1 uni dimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Exclusion Criteria
* Major surgery within 28 days before start of trial treatment.
* Systemic therapy with immunosuppressive agents within 7 days prior to the first dose of study drug; or use any investigational drug within 28 days before the start of trial treatment.
* With any active autoimmune disease or history of autoimmune disease.
* With active central nervous system (CNS) metastases causing clinical symptoms or requiring therapeutic intervention.
* History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immunedeficient disease, or any active systemic viral infection requiring therapy.
* Previous malignant disease (other than the target malignancy to be investigated in the trial) within the last 2 years. Subjects with history of cervical carcinoma in situ, superficial or non-invasive bladder cancer or basal cell or squamous cell cancer in situ previously treated with curative intent are NOT excluded.
18 Years
75 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Cancer Hospital of Guangzhou Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHR-1701-II-203-NPC
Identifier Type: -
Identifier Source: org_study_id
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