Clinical trial NCT03486678: SHR-1210 in Combination With GEMOX in Patients With Advanced BTC
Official title: A Single-arm, Open-label and Exploratory Clinical Study of PD-1 Monoclonal Antibody SHR-1210 in Combination With GEMOX (Gemcitabine Combined Oxaliplatin) in Patients With Advanced Biliary Tract Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Biliary Tract Cancer
Cholangiocarcinoma
Keywords: BTC
PD-1 antibody
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2018-04-03
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-arm, open-label and exploratory clinical study of PD-1 monoclonal antibody SHR-1210 combined with GEMOX regimen (gemcitabine combined oxaliplatin) in the treatment of advanced biliary malignancies.

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.


Eligibility criteria: Inclusion Criteria:

* Pathology confirmed biliary malignancy, including intrahepatic bile duct carcinoma, extrahepatic bile duct carcinoma, and gallbladder carcinoma.
* 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:

* There were concurrent malignant tumors, except for the cured skin basal cell carcinoma and cervical carcinoma in situ.
* 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;

Primary outcomes:
measure: 6-month Progression Free Survival (PFS) rate
timeFrame: from the first drug administration up to 6 months
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: from the first drug administration to within 90 days for the last SHR-1210 dose
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: from the first drug administration up to two years
measure: Duration of response (DOR)
timeFrame: from the first drug administration up to two years
measure: Disease Control Rate (DCR)
timeFrame: from the first drug administration up to two years
measure: 12-month Overall survival (OS) rate
timeFrame: from the first drug administration up to approximately 12 months
measure: OS
timeFrame: from the first drug administration up to 2 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
Study officials:
affiliation: JANGSU PROVINCE HOSPITAL
name: Yongqian Shu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.