Anti-metabolites

Tislelizumab for Gastric Cancer

Tennessee Oncology, PLLC - Nashville, Nashville, TN

Tislelizumab +5 morePhase 3Waitlist AvailableResearch Sponsored by BeiGene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to 48 months

Awards & highlights

Approved for 10 Other Conditions

Pivotal Trial

Study Summary

This trial is testing a new cancer drug against placebo to see if it is more effective at treating gastric or gastroesophageal junction cancer.

Eligible Conditions

Gastric Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival (OS)

Secondary outcome measures

Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Score (EORTC QLQ-30)

Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Gastric Cancer Module QLQ-STO22 (EORTC QLQ-STO22)

Change from baseline in European Quality of Life 5-Dimensions 5-Levels Health Questionnaire Score (EQ-5D-5L)

+8 more

Side effects data

From 2021 Phase 2 trial • 113 Patients • NCT04004221

39%

Anaemia

22%

Constipation

20%

Urinary tract infection

20%

Decreased appetite

20%

Pruritus

19%

Pyrexia

19%

Aspartate aminotransferase increased

19%

Hyponatraemia

18%

Hypoalbuminaemia

17%

Alanine aminotransferase increased

17%

Blood creatinine increased

15%

Rash

13%

Blood alkaline phosphatase increased

12%

Nausea

11%

Abdominal distension

11%

Back pain

10%

Hypothyroidism

10%

Upper respiratory tract infection

Fatigue

Diarrhoea

Vomiting

Nasopharyngitis

Blood lactate dehydrogenase increased

Asthenia

Abdominal pain

Blood urea increased

Proteinuria

Cough

White blood cell count decreased

Oedema peripheral

Blood bilirubin increased

Gamma-glutamyltransferase increased

Haematuria

Hyperkalaemia

Blood creatine phosphokinase MB increased

Weight decreased

Hyperglycaemia

Hyperuricaemia

Hyperthyroidism

Neutrophil count decreased

Platelet count decreased

Hypertriglyceridaemia

Dizziness

Insomnia

Hypokalaemia

Pneumonia

Drug eruption

General physical health deterioration

Hepatic failure

Hypercalcaemia

Cancer pain

Renal failure

Deep vein thrombosis

Multiple organ dysfunction syndrome

Bile duct stenosis

Liver injury

Cardiac failure

Agranulocytosis

Ventricular fibrillation

Sepsis

Optic nerve injury

Hypoproteinaemia

Pathological fracture

Malignant ascites

Brain oedema

Paraplegia

Subarachnoid haemorrhage

Device occlusion

Hydronephrosis

Dyspnoea

Immune-mediated pneumonitis

Respiratory arrest

Respiratory failure

Dermatitis allergic

Gastritis

Gastrointestinal haemorrhage

Ileus

Pancreatitis

Pancreatitis acute

Death

Abdominal infection

Febrile infection

Kidney infection

Facial bones fracture

Renal impairment

Renal injury

Shock haemorrhagic

Blood loss anaemia

Thrombocytopenia

100%

80%

60%

40%

20%

Study treatment Arm

Tislelizumab

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Tislelizumab (BGB-A317) + chemotherapyExperimental Treatment5 Interventions

Tislelizumab and chemotherapy. Oxaliplatin + capecitabine or cisplatin + 5-Fluorouracil regimens are used as the backbone chemotherapy.

Group II: Placebo + chemotherapyPlacebo Group5 Interventions

Placebo and chemotherapy. Oxaliplatin + capecitabine or cisplatin + 5-FU regimens are used as the backbone chemotherapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tislelizumab

Not yet FDA approved

Cisplatin

FDA approved

Capecitabine

FDA approved

Oxaliplatin

FDA approved

5-FU

2011

Completed Phase 3

~3660

Do I qualify?Apply below to find out

Find a site

Who is running the clinical trial?

BeiGeneLead Sponsor

165 Previous Clinical Trials

26,246 Total Patients Enrolled

Jin Wang, MDStudy Director

BeiGene

Media Library

5-FU (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03777657 — Phase 3

Gastric Cancer Research Study Groups: Tislelizumab (BGB-A317) + chemotherapy, Placebo + chemotherapy

Gastric Cancer Clinical Trial 2023: 5-FU Highlights & Side Effects. Trial Name: NCT03777657 — Phase 3

5-FU (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03777657 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Tislelizumab likely to cause any negative side effects in patients?

"Tislelizumab's safety is estimated to be a 3. This assessment comes from the fact that Tislelizumab is in Phase 3 of clinical trials. At this stage, there is already some data supporting efficacy and multiple rounds of data supporting safety."

Answered by AI

What are the most common benefits of Tislelizumab?

"Tislelizumab is not just effective against refractory fallopian tube carcinoma, but also advanced ovarian cancer, metastatic colorectal carcinoma, and pancreatic endocrine carcinoma."

Answered by AI

Where are patients being asked to participate in this experiment?

"There are 7 locations available for this study, which include Reading Hospital in West Reading, Fox Chase Cancer Center in Philadelphia, and University of California Davis Health System in Sacramento."

Answered by AI

What do we know about Tislelizumab from other research?

"As of right now, there are a whopping 1326 different clinical trials underway that involve Tislelizumab. That being said, 461 of those studies are still in Phase 3. The majority of these research programs are based out of Guangzhou, Guangdong; however, there are 61814 locations worldwide where Tislelizumab is being trialed as a potential treatment option."

Answered by AI

Are there any spots left for new participants in this scientific experiment?

"No, the trial is not currently recruiting patients. The last update on clinicaltrials.gov was on August 25th, 2022 and indicated that the study is not presently looking for new candidates. There are 2309 other trials you may be eligible for."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03777657.

All > Esophagus Cancer > Esophageal Cancer