Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03486678
Recruitment Status : Recruiting
First Posted : April 3, 2018
Last Update Posted : May 10, 2018
Sponsor:
Collaborator:
Jiangsu HengRui Medicine Co., Ltd.
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University

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.


Condition or disease Intervention/treatment Phase
Biliary Tract Cancer Cholangiocarcinoma Drug: SHR-1210+GEMOX Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 10, 2018
Estimated Primary Completion Date : April 8, 2019
Estimated Study Completion Date : April 8, 2020


Arm Intervention/treatment
Experimental: SHR1210+GEMOX
This is a single arm trial. Participants will receive SHR1210 + GEMOX treatment.
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.




Primary Outcome Measures :
  1. 6-month Progression Free Survival (PFS) rate [ Time Frame: from the first drug administration up to 6 months ]
    the rate of 6-month progression free survival

  2. Incidence of Treatment-Emergent Adverse Events [ Time Frame: from the first drug administration to within 90 days for the last SHR-1210 dose ]
    Incidence of Treatment-Emergent Adverse Events, especially immune related adverse events


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: from the first drug administration up to two years ]
    the best Objective Response Rate

  2. Duration of response (DOR) [ Time Frame: from the first drug administration up to two years ]
    Duration of response

  3. Disease Control Rate (DCR) [ Time Frame: from the first drug administration up to two years ]
    the Rate of Disease Control

  4. 12-month Overall survival (OS) rate [ Time Frame: from the first drug administration up to approximately 12 months ]
    Overall Survival rate at 12 months

  5. OS [ Time Frame: from the first drug administration up to 2 years ]
    Overall survival



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486678


Contacts
Layout table for location contacts
Contact: Yongqian Shu, PhD 00862568306428 shuyongqian@csco.org.cn
Contact: Xiaofeng Chen, PhD 008613585172006 xiaofengch198019@126.com

Locations
Layout table for location information
China, Jiangsu
Jiangsu Province Hospital Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Yongqian Shu, PhD    00862568306428    shuyongqian@csco.org.cn   
Contact: Xiaofeng Chen, PhD    008613585172006    xiaofengch198019@126.com   
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Jiangsu HengRui Medicine Co., Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Yongqian Shu, PhD JANGSU PROVINCE HOSPITAL

Layout table for additonal information
Responsible Party: The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03486678     History of Changes
Other Study ID Numbers: SHR1210-GEMOX-BTC-IIT03
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The First Affiliated Hospital with Nanjing Medical University:
BTC
PD-1 antibody

Additional relevant MeSH terms:
Layout table for MeSH terms
Cholangiocarcinoma
Biliary Tract Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Antibodies
Oxaliplatin
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents