Back to resultsSHR-1210 in Combination With GEMOX in Patients With Advanced BTC
Primary Purpose
Biliary Tract Cancer, Cholangiocarcinoma
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR-1210+GEMOX
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Tract Cancer focused on measuring BTC, PD-1 antibody
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;
Sites / Locations
- Jiangsu Province Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SHR1210+GEMOX
Arm Description
This is a single arm trial. Participants will receive SHR1210 + GEMOX treatment.
Outcomes
Primary Outcome Measures
6-month Progression Free Survival (PFS) rate
the rate of 6-month progression free survival
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events, especially immune related adverse events
Secondary Outcome Measures
Objective Response Rate (ORR)
the best Objective Response Rate
Duration of response (DOR)
Duration of response
Disease Control Rate (DCR)
the Rate of Disease Control
12-month Overall survival (OS) rate
Overall Survival rate at 12 months
OS
Overall survival
Full Information
NCT ID
NCT03486678
First Posted
February 1, 2018
Last Updated
October 27, 2021
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03486678
Brief Title
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
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
February 10, 2018 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Cancer, Cholangiocarcinoma
Keywords
BTC, PD-1 antibody
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SHR1210+GEMOX
Arm Type
Experimental
Arm Description
This is a single arm trial. Participants will receive SHR1210 + GEMOX treatment.
Intervention Type
Drug
Intervention Name(s)
SHR-1210+GEMOX
Intervention Description
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.
Primary Outcome Measure Information:
Title
6-month Progression Free Survival (PFS) rate
Description
the rate of 6-month progression free survival
Time Frame
from the first drug administration up to 6 months
Title
Incidence of Treatment-Emergent Adverse Events
Description
Incidence of Treatment-Emergent Adverse Events, especially immune related adverse events
Time Frame
from the first drug administration to within 90 days for the last SHR-1210 dose
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
the best Objective Response Rate
Time Frame
from the first drug administration up to two years
Title
Duration of response (DOR)
Description
Duration of response
Time Frame
from the first drug administration up to two years
Title
Disease Control Rate (DCR)
Description
the Rate of Disease Control
Time Frame
from the first drug administration up to two years
Title
12-month Overall survival (OS) rate
Description
Overall Survival rate at 12 months
Time Frame
from the first drug administration up to approximately 12 months
Title
OS
Description
Overall survival
Time Frame
from the first drug administration up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongqian Shu, PhD
Organizational Affiliation
JANGSU PROVINCE HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34795005
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.
Results Reference
derived
PubMed Identifier
33172881
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.
Results Reference
derived
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SHR-1210 in Combination With GEMOX in Patients With Advanced BTC
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