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

October 27, 2021 updated by: The First Affiliated Hospital with Nanjing Medical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Province Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from the first drug administration up to 6 months
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
from the first drug administration to within 90 days for the last SHR-1210 dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: from the first drug administration up to two years
the best Objective Response Rate
from the first drug administration up to two years
Duration of response (DOR)
Time Frame: from the first drug administration up to two years
Duration of response
from the first drug administration up to two years
Disease Control Rate (DCR)
Time Frame: from the first drug administration up to two years
the Rate of Disease Control
from the first drug administration up to two years
12-month Overall survival (OS) rate
Time Frame: from the first drug administration up to approximately 12 months
Overall Survival rate at 12 months
from the first drug administration up to approximately 12 months
OS
Time Frame: from the first drug administration up to 2 years
Overall survival
from the first drug administration up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 10, 2018

Primary Completion (ACTUAL)

August 1, 2020

Study Completion (ACTUAL)

November 30, 2020

Study Registration Dates

First Submitted

February 1, 2018

First Submitted That Met QC Criteria

April 1, 2018

First Posted (ACTUAL)

April 3, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 28, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR1210-GEMOX-BTC-IIT03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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