BGB A317 in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Carcinoma

PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

July 18, 2017

Primary Completion Date

March 31, 2019

Study Completion Date

August 19, 2020

Conditions
Esophageal Squamous Cell Carcinoma, Gastric Carcinoma, Gastroesophageal Junction Carcinoma
Interventions
DRUG

Tislelizumab

Subjects will be treated with BGB A317 200 mg IV on Day 1 during each 21-day cycle. BGB A317 will be administered until disease progression, intolerable toxicity, or treatment discontinuation for any other reason.

DRUG

Cisplatin

Subjects will be treated with cisplatin 80 mg/m² IV on Day 1 during each 21-day cycle. Cisplatinwill be given for up to 6 cycles.

DRUG

5-FU

Subjects will be treated with 5-FU 800 mg/m²/day IV using continuous pumping system on Days 1 through 5 during each 21-day cycle. 5-FU will be given for up to 6 cycles.

DRUG

Oxaliplatin

Subjects will be treated with oxaliplatin 130 mg/m² IV on Day 1 during each 21-day cycle. Oxaliplatin will be administered for up to 6 cycles.

DRUG

Capecitabine

Subjects will be treated with capecitabine 1000 mg/m² orally twice daily (bid) Days 1 through 14 (14 days total) during each 21-day cycle. Capecitabine will be administered until disease progression, intolerable toxicity, or treatment discontinuation for any other reason.

Trial Locations (6)

100071

Fifth Medical Center of Pla General Hospital, Beijing

150000

Harbin Medical University Cancer Hospital, Harbin

225001

Northern Jiangsu Peoples Hospital, Yangzhou

310003

The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou

430030

Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology, Wuhan

710061

The First Affiliated Hospital of Xian Jiaotong University, Xi'an

Sponsors

Lead Sponsor

All Listed Sponsors
lead

BeiGene

INDUSTRY

NCT03469557 - BGB A317 in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Carcinoma | Biotech Hunter | Biotech Hunter