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

NCT03486678 | Completed Phase 2 DMC

• 1 other identifier: SHR1210-GEMOX-BTC-IIT03
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Tract Cancer; Cholangiocarcinoma

Keywords

BTC; PD-1 antibody

Outcome Measures

Primary Outcomes (2)

• 6-month Progression Free Survival (PFS) rate

  the rate of 6-month progression free survival

  from the first drug administration up to 6 months

• 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 Outcomes (5)

• Objective Response Rate (ORR)

  from the first drug administration up to two years

• Duration of response (DOR)

  from the first drug administration up to two years

• Disease Control Rate (DCR)

  from the first drug administration up to two years

• 12-month Overall survival (OS) rate

  from the first drug administration up to approximately 12 months

• OS

  from the first drug administration up to 2 years

Study Arms (1)

SHR1210+GEMOX

EXPERIMENTAL

This is a single arm trial. Participants will receive SHR1210 + GEMOX treatment.

Drug: SHR-1210+GEMOX

Interventions

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.

SHR1210+GEMOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

Related Publications (3)

• Liu QP, Tang J, Chen YZ, Guo F, Ma L, Pan LL, Tian YT, Wu XF, Zhang YD, Chen XF. Immuno-genomic-radiomics to predict response of biliary tract cancer to camrelizumab plus GEMOX in a single-arm phase II trial. JHEP Rep. 2023 Apr 22;5(7):100763. doi: 10.1016/j.jhepr.2023.100763. eCollection 2023 Jul.

  PMID: 37333974 DERIVED

• Chen X, Wang D, Liu J, Qiu J, Zhou J, Ying J, Shi Y, Wang Z, Lou H, Cui J, Zhang J, Liu Y, Zhao F, Pan L, Zhao J, Zhu D, Chen S, Li X, Li X, Zhu L, Shao Y, Shu Y. Genomic alterations in biliary tract cancer predict prognosis and immunotherapy outcomes. J Immunother Cancer. 2021 Nov;9(11):e003214. doi: 10.1136/jitc-2021-003214.

  PMID: 34795005 DERIVED

• Chen X, Wu X, Wu H, Gu Y, Shao Y, Shao Q, Zhu F, Li X, Qian X, Hu J, Zhao F, Mao W, Sun J, Wang J, Han G, Li C, Xia Y, Seesaha PK, Zhu D, Li H, Zhang J, Wang G, Wang X, Li X, Shu Y. Camrelizumab plus gemcitabine and oxaliplatin (GEMOX) in patients with advanced biliary tract cancer: a single-arm, open-label, phase II trial. J Immunother Cancer. 2020 Nov;8(2):e001240. doi: 10.1136/jitc-2020-001240.

  PMID: 33172881 DERIVED

MeSH Terms

Conditions

Biliary Tract Neoplasms; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Yongqian Shu, PhD

  JANGSU PROVINCE HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: April 3, 2018
• Study Start: February 10, 2018
• Primary Completion: August 1, 2020
• Study Completion: November 30, 2020
• Last Updated: October 28, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)