Status:
COMPLETED
SHR-1210 in Combination With GEMOX in Patients With Advanced BTC
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Collaborating Sponsors:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Biliary Tract Cancer
Cholangiocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
February 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2020
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT03486678
Start Date
February 10 2018
End Date
November 30 2020
Last Update
October 28 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029