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Tislelizumab Combined With Anlotinib and Chemotherapy (XELOX) in the Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (TALENT)

NCT04963088 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-06-26

No results posted yet for this study

Summary

This is a Phase 2, multi-cohort study to investigate safety, anti-tumor activity of the monoclonal antibody BGB A317 in combination with Anlotinib and standard chemotherapy as first-line treatment in Gastric, or Gastroesophageal Junction Carcinoma. The study includes a screening (up to 28 days), treatment (until disease progression, intolerable toxicity, or treatment withdrawal for another reason), safety follow-up (up to 30 days following last study drug treatment), and survival follow-up phase.

Conditions

Interventions

DRUG

BGB-A317

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

Anlotinib

oral administration daily d1-d14, q3w;

DRUG

Oxaliplatin

30 mg/m² IV on Day 1 during each 21-day cycle. during each 21-day cycle

DRUG

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.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-06
Primary Completion
2024-03-15
Completion
2024-03-20

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04963088 on ClinicalTrials.gov