- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04963088
TISLELIZUMAB Combined With Anlotinib and Chemotherapy(XELOX) in the Treatment of Advanced Gastric Carcinoma (TAXE-GC)
July 5, 2021 updated by: The First Affiliated Hospital with Nanjing Medical University
TISLELIZUMAB in Combination With Anlotinib and Chemotherapy(XELOX) as First-Line Treatment in Adults With Inoperable, Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
66
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yongqian Shu, PhD
- Phone Number: 00862568306428
- Email: shuyongqian@csco.org.cn
Study Contact Backup
- Name: Xiaofeng Chen, PhD
- Phone Number: 008613585172006
- Email: xiaofengch198019@126.com
Study Locations
-
-
-
Nanjing, China
- Recruiting
- The First Affiliated Hospital with Nanjing Medical University
-
Contact:
- Yongqian Shu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- Albumin ≥ 3.0 g/dL or 30 g/liter
- Weighs more than 40 kg (including 40 kg) or BMI 18.5
- Females of childbearing potential must have a negative urine or serum pregnancy test within 7 days of randomization and must be willing to use a highly effective method of birth control (Appendix 9) for the duration of the study, and ≥ 120 days after the last dose of tislelizumab or placebo and 180 days after the last dose of chemotherapy.
- Non-sterile males must be willing to use a highly effective method of birth control (Appendix 9) for the duration of the study and for ≥ 120 days after the last dose of tislelizumab or placebo and 180 days after the last dose of chemotherapy.
Exclusion Criteria:
- 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;
- History of severe chronic autoimmune diseases, such as systemic lupus erythematosus; history of inflammatory bowel disease such as ulcerative enteritis, Crohn's disease, irritable bowel syndrome and other chronic diarrheal diseases; history of sarcoidosis or tuberculosis; history of active hepatitis B, C and HIV infection; well-controlled non-serious immune diseases, such as dermatitis, arthritis, psoriasis, etc. Hepatitis B virus < 1000 copies/ml can be detected.
- Patients with hypersensitivity to human or murine monoclonal antibodies
- Patients with a history of psychotropic substance abuse and unable to quit or with mental disorders;
- Pleural or peritoneal effusion with clinical symptoms requiring clinical intervention;
- Patients who do not follow the doctor's advice, do not take medicine as required, or have insufficient data that can affect the efficacy judgment or safety judgment;
- Patients with concomitant diseases that, in the judgment of the investigator, seriously jeopardize the patient's safety or affect the patient's completion of the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TISLELIZUMAB、Anlotinib plus XELOX
|
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
oral administration daily d1-d14, q3w;
30 mg/m² IV on Day 1 during each 21-day cycle.
during each 21-day cycle
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MTD
Time Frame: 6 months
|
Maximum tolerated dose
|
6 months
|
ORR
Time Frame: through study completion, an average of 18 month
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: up to 2 years
|
Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.
|
up to 2 years
|
Progression-free survival
Time Frame: up to 2 years
|
he PFS was calculated from the initiation of chemotherapy to the date of disease progression or death.
|
up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 6, 2021
Primary Completion (Anticipated)
September 20, 2022
Study Completion (Anticipated)
March 20, 2024
Study Registration Dates
First Submitted
June 21, 2021
First Submitted That Met QC Criteria
July 5, 2021
First Posted (Actual)
July 15, 2021
Study Record Updates
Last Update Posted (Actual)
July 15, 2021
Last Update Submitted That Met QC Criteria
July 5, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Stomach Neoplasms
- Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Capecitabine
- Oxaliplatin
Other Study ID Numbers
- BGB-A317-ANLO-XELOX GC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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