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Tislelizumab in Combination W...

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

Last Updated: 2025-02-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

997 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-13

Study Completion Date

2024-08-27

Brief Summary

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This study was designed to compare the efficacy and safety of tislelizumab plus chemotherapy versus placebo plus chemotherapy as the first treatment (first-line) for adults diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

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Detailed Description

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Conditions

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Gastric, or Gastroesophageal Junction Adenocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Tislelizumab + Chemotherapy

Participants received 200 mg of tislelizumab intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Chemotherapy consisted of 1000 mg/m² capecitabine twice daily on Days 1-14 and 130 mg/m² oxaliplatin on Day 1, or 800 mg/m² 5-fluorouracil (5-FU) on Days 1-5 and 80 mg/m² cisplatin on Day 1 of each 21-day cycle. Thereafter, participants continued treatment with 200 mg tislelizumab, with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type DRUG

200 mg intravenously (IV) on Day 1 of each 21-day cycle

Cisplatin

Intervention Type DRUG

80 mg/m² IV on Day 1 of each 21-day cycle

Oxaliplatin

Intervention Type DRUG

130 mg/m² IV on Day 1 of each 21-day cycle

Capecitabine

Intervention Type DRUG

1000 mg/m² orally twice daily (BD) Days 1 through 14 (14 days total) of each 21-day cycle

5-Fluorouracil

Intervention Type DRUG

800 mg/m²/day IV using continuous infusion on Days 1 to 5 of each 21-day cycle

Placebo + Chemotherapy

Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Chemotherapy consisted of 1000 mg/m² capecitabine twice daily on Days 1-14 and 130 mg/m² oxaliplatin on Day 1, or 800 mg/m² 5-FU on Days 1-5 and 80 mg/m² cisplatin on Day 1 of each 21-day cycle. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to match tislelizumab IV on Day 1 of each 21-day cycle

Cisplatin

Intervention Type DRUG

80 mg/m² IV on Day 1 of each 21-day cycle

Oxaliplatin

Intervention Type DRUG

130 mg/m² IV on Day 1 of each 21-day cycle

Capecitabine

Intervention Type DRUG

1000 mg/m² orally twice daily (BD) Days 1 through 14 (14 days total) of each 21-day cycle

5-Fluorouracil

Intervention Type DRUG

800 mg/m²/day IV using continuous infusion on Days 1 to 5 of each 21-day cycle

Interventions

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Tislelizumab

200 mg intravenously (IV) on Day 1 of each 21-day cycle

Intervention Type DRUG

Placebo

Placebo to match tislelizumab IV on Day 1 of each 21-day cycle

Intervention Type DRUG

Cisplatin

80 mg/m² IV on Day 1 of each 21-day cycle

Intervention Type DRUG

Oxaliplatin

130 mg/m² IV on Day 1 of each 21-day cycle

Intervention Type DRUG

Capecitabine

1000 mg/m² orally twice daily (BD) Days 1 through 14 (14 days total) of each 21-day cycle

Intervention Type DRUG

5-Fluorouracil

800 mg/m²/day IV using continuous infusion on Days 1 to 5 of each 21-day cycle

Intervention Type DRUG

Other Intervention Names

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BGB-A317 TEVIMBRA®

Eligibility Criteria

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Inclusion Criteria

1. Locally advanced unresectable or metastatic gastric cancer (GC) or gastroesophageal junction (GEJ) carcinoma and have histologically confirmed adenocarcinoma
2. No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer. NOTE: Participants may have received prior neoadjuvant or adjuvant therapy as long as it was completed and have no recurrence or disease progression for at least 6 months.
3. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1 within 7 days prior to randomization
4. Adequate organ function ≤ 7 days prior to randomization

Exclusion Criteria

1. Has squamous cell or undifferentiated or other histological type GC
2. Active leptomeningeal disease or uncontrolled brain metastasis
3. Diagnosed with gastric or GEJ adenocarcinoma with positive HER2
4. Prior therapy with an anti-programmed cell death protein-1 (PD-1), anti-programmed cell death protein ligand-1 (PD-L1), anti-programmed cell death protein ligand-2 (PD-L2), or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jin Wang, MD

Role: STUDY_DIRECTOR

BeiGene

Locations

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University of California Davis Health System

Sacramento, California, United States

Site Status

Southeastern Regional Medical Center

Newnan, Georgia, United States

Site Status

Ohio State University Hospital

Columbus, Ohio, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Reading Hospital

West Reading, Pennsylvania, United States

Site Status

Tennessee Oncology, Pllc Nashville

Nashville, Tennessee, United States

Site Status

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Site Status

Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital

Hefei, Anhui, China

Site Status