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NCT Number: NCT03486678

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

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.

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Key information

Conditions

Biliary Tract Cancer Adenocarcinoma Biliary Tract Diseases Biliary Tract Neoplasms Carcinoma Cholangiocarcinoma Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

SHR-1210+GEMOX

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 3, 2018
Registry last updated
Oct 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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