SHR-1210 in Combination With GEMOX in Patients With Advanced BTC
NCT ID: NCT03486678
Last Updated: 2021-10-28
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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COMPLETED
PHASE2
38 participants
INTERVENTIONAL
2018-02-10
2020-11-30
Brief Summary
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In oder to observe and evaluate the efficacy and safety of PD-1 antibody SHR-1210 combined with GEMOX in the treatment of patients with advanced biliary malignant tumor (BTC),subjects with pathological confirmed biliary cancer, including intrahepatic bile duct carcinoma, extrahepatic bile duct carcinoma, and gallbladder carcinoma will be enrolled.
28 days as a treatment cycle, SHR-1210 3mg/kg and Gemcitabine 800 mg/m2 will be administered IV Q2W (D1 and D15 of a treatment cycle),and Oxaliplatin 85mg/m2 will be administered IV Q2W (D2 and D16 of a treatment cycle). PD-1 antibody combined chemotherapy will be used up to 6 cycles.SHR-1210 3mg/kg IV Q2W will be administered beyond 6 cycles chemotherapy until disease progression or un-tolerable toxicity.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SHR1210+GEMOX
This is a single arm trial. Participants will receive SHR1210 + GEMOX treatment.
SHR-1210+GEMOX
28 days as a treatment cycle, SHR-1210 3mg/kg and Gemcitabine 800 mg/m2 will be administered IV Q2W (D1 and D15 of a treatment cycle),and Oxaliplatin 85mg/m2 will be administered IV Q2W (D2 and D16 of a treatment cycle). PD-1 antibody combined chemotherapy used up to 6 cycles.SHR-1210 3mg/kg IV Q2W will be administered beyond chemotherapy until the disease progression or untolerable toxicity.
Interventions
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SHR-1210+GEMOX
28 days as a treatment cycle, SHR-1210 3mg/kg and Gemcitabine 800 mg/m2 will be administered IV Q2W (D1 and D15 of a treatment cycle),and Oxaliplatin 85mg/m2 will be administered IV Q2W (D2 and D16 of a treatment cycle). PD-1 antibody combined chemotherapy used up to 6 cycles.SHR-1210 3mg/kg IV Q2W will be administered beyond chemotherapy until the disease progression or untolerable toxicity.
Eligibility Criteria
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Inclusion Criteria
* Age:18-75 years, male or female.
* The estimated survival period is more than 3 months.
* ECOG 0-1.
* There is at least one measurable lesion, according to the RECIST 1.1 standard.
* Patients has not been treated by oxaliplatin, gemcitabine and pd-1 / pd-l1 antibody.
* Patients who have been treated tegafur or capecitabine as adjuvant chemotherapy or first-line treatment may be selected.
Exclusion Criteria
* Other drug clinical trials have been taken in four weeks.
* Patients with a history of central nervous system metastasis or central nervous system metastasis are known before the screening.
* Patients with a history of unstable angina.
* The urine routine indicated that the urine protein was greater than ++ and confirmed the 24-hour urine protein quantification \>1.0 g.
* Have used immune-targeted therapy drugs.
* The patient had received a liver transplant.
* Having a history of chronic autoimmune diseases such as systemic lupus erythematosus.
* Having a history of immunodeficiency, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;
18 Years
75 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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Principal Investigators
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Yongqian Shu, PhD
Role: PRINCIPAL_INVESTIGATOR
JANGSU PROVINCE HOSPITAL
Locations
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Jiangsu Province Hospital
Nanjing, Jiangsu, China
Countries
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References
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Liu QP, Tang J, Chen YZ, Guo F, Ma L, Pan LL, Tian YT, Wu XF, Zhang YD, Chen XF. Immuno-genomic-radiomics to predict response of biliary tract cancer to camrelizumab plus GEMOX in a single-arm phase II trial. JHEP Rep. 2023 Apr 22;5(7):100763. doi: 10.1016/j.jhepr.2023.100763. eCollection 2023 Jul.
Chen X, Wang D, Liu J, Qiu J, Zhou J, Ying J, Shi Y, Wang Z, Lou H, Cui J, Zhang J, Liu Y, Zhao F, Pan L, Zhao J, Zhu D, Chen S, Li X, Li X, Zhu L, Shao Y, Shu Y. Genomic alterations in biliary tract cancer predict prognosis and immunotherapy outcomes. J Immunother Cancer. 2021 Nov;9(11):e003214. doi: 10.1136/jitc-2021-003214.
Chen X, Wu X, Wu H, Gu Y, Shao Y, Shao Q, Zhu F, Li X, Qian X, Hu J, Zhao F, Mao W, Sun J, Wang J, Han G, Li C, Xia Y, Seesaha PK, Zhu D, Li H, Zhang J, Wang G, Wang X, Li X, Shu Y. Camrelizumab plus gemcitabine and oxaliplatin (GEMOX) in patients with advanced biliary tract cancer: a single-arm, open-label, phase II trial. J Immunother Cancer. 2020 Nov;8(2):e001240. doi: 10.1136/jitc-2020-001240.
Other Identifiers
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SHR1210-GEMOX-BTC-IIT03
Identifier Type: -
Identifier Source: org_study_id