SHR-1210 in Combination With GEMOX in Patients With Advanced BTC

Cholangiocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03486678
• Other study ID #: SHR1210-GEMOX-BTC-IIT03
• Status: Completed
• Phase: Phase 2
• Start date: February 10, 2018
• Est. completion date: November 30, 2020

Study information

• Verified date: October 2021
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 30, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms
• Cholangiocarcinoma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Jiangsu Province Hospital	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University	Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-month Progression Free Survival (PFS) rate	the rate of 6-month progression free survival	from the first drug administration up to 6 months
Primary	Incidence of Treatment-Emergent Adverse Events	Incidence of Treatment-Emergent Adverse Events, especially immune related adverse events	from the first drug administration to within 90 days for the last SHR-1210 dose
Secondary	Objective Response Rate (ORR)	the best Objective Response Rate	from the first drug administration up to two years
Secondary	Duration of response (DOR)	Duration of response	from the first drug administration up to two years
Secondary	Disease Control Rate (DCR)	the Rate of Disease Control	from the first drug administration up to two years
Secondary	12-month Overall survival (OS) rate	Overall Survival rate at 12 months	from the first drug administration up to approximately 12 months
Secondary	OS	Overall survival	from the first drug administration up to 2 years