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

NCT04963088 | Completed Phase 1

• 1 other identifier: BGB-A317-ANLO-XELOX GC
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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

Gastric Cancer

Outcome Measures

Primary Outcomes (2)

• MTD

  Maximum tolerated dose

  6 months

• ORR

  Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission

  through study completion, an average of 18 month

Secondary Outcomes (2)

• Overall Survival

  up to 2 years

• Progression-free survival

  up to 2 years

Study Arms (1)

TISLELIZUMAB、Anlotinib plus XELOX

EXPERIMENTAL

Drug: BGB-A317; Drug: Anlotinib; Drug: Oxaliplatin; Drug: Capecitabine

Interventions

BGB-A317 DRUG

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

TISLELIZUMAB、Anlotinib plus XELOX

Anlotinib DRUG

oral administration daily d1-d14, q3w;

TISLELIZUMAB、Anlotinib plus XELOX

Oxaliplatin DRUG

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

TISLELIZUMAB、Anlotinib plus XELOX

Capecitabine DRUG

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.

TISLELIZUMAB、Anlotinib plus XELOX

Eligibility Criteria

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

You may qualify if:

• Able to provide written informed consent and can understand and comply with the requirements of the study
• Adult patients (≥ 18 years of age or acceptable age according to local regulations, whichever is older) at the time of voluntarily signing informed consent
• Locally advanced unresectable or metastatic GC or GEJ carcinoma and have histologically confirmed adenocarcinoma
• At least 1 measurable or non-measurable lesion per RECIST v1.1 as determined by investigator assessment.
• No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer. NOTE: Patients 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.
• ECOG PS ≤ 1 within 7 days prior to randomization
• Estimated lifetime is greater than 3 months
• Adequate organ function as indicated by the following laboratory values ≤ 7 days prior to randomization:
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, hemoglobin
• ≥ 90 g/L. NOTE: Patients must not have required a blood transfusion or growth factor support ≤ 14 days before sample collection
• Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated Glomerular Filtration Rate ≥ 60 mL/min/1.73 m2. (Appendix 8)
• Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
• Serum total bilirubin ≤ 1.5 x ULN (total bilirubin must be \< 3 x ULN for patients with Gilberts syndrome)
• International normalized ratio (INR) or prothrombin time (PT) (or prothrombin time ratio) ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy and PT values are within the intended therapeutic range of the anticoagulant
• Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN

You may not qualify if:

• Previous or concurrent other malignant tumors, but cured early tumors, including skin basal cell carcinoma and cervical carcinoma in situ, stage I lung cancer, stage I colorectal cancer.
• Tumors that do not affect the patient's life in a short period of time as judged by the investigator can be excluded
• Participation in other drug clinical trials within four weeks;
• Multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction.
• History of bleeding, any bleeding event with a severity grade of 3 or higher per CTCAE 5.0 within 4 weeks before screening;
• Patients with known central nervous system metastasis or history of central nervous system metastasis prior to screening. For patients with clinically suspected central nervous system metastases, CT or MRI must be performed within 28 days before enrollment to rule out central nervous system metastases.
• Patients with hypertension and uncontrolled by antihypertensive drugs alone (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg); Patients with a history of unstable angina pectoris; Patients newly diagnosed as angina pectoris within 3 months before screening or myocardial infarction events within 6 months before screening; Arrhythmias (including QTcF ≥ 450 ms in men, ≥ 470 ms in women requiring long-term use of antiarrhythmic drugs and New York Heart Association Class ≥ II cardiac insufficiency;There are many factors that affect oral drug absorption (such as inability to swallow, nausea and vomiting, upper gastrointestinal obstruction, abnormal physiological function, malabsorption syndrome, etc.), which may affect anlotinib hydrochloride absorbers.
• Long-term unhealed wound or unhealed fracture;
• Imaging findings show that the tumor has invaded around important blood vessels or the patient's tumor has a very high possibility of invading important blood vessels during treatment and causing fatal massive hemorrhage as judged by the investigator
• Patients with abnormal coagulation function and bleeding tendency (the following criteria must be met within 14 days before randomization: INR is within normal range without anticoagulants or has no clinically significant abnormality); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; patients with prothrombin time international normalized ratio (INR) ≤ 1.5 are allowed to take low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (the daily dose does not exceed 100 mg) for preventive purposes
• Arteriovenous thrombotic events occurred within 6 months before screening, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis (except venous thrombosis caused by previous chemotherapy that has been judged by the investigator to have recovered) and pulmonary embolism
• Urine routine showed urine protein and 24 h urine protein was confirmed to be \> 1.0g
• Previous use of immune targeted therapy drugs;
• History of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
• Patients with infectious pneumonia, pneumonitis, interstitial pneumonia and other conditions requiring corticosteroids;

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

tislelizumab; anlotinib; Oxaliplatin; Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: July 15, 2021
• Study Start: March 6, 2021
• Primary Completion: March 15, 2024
• Study Completion: March 20, 2024
• Last Updated: June 26, 2025

Record last verified: 2024-04

Locations

CN (1)