What is the mechanism of action of this treatment?

The most common treatments for gastric cancer include chemotherapy, targeted therapy, and immunotherapy. Immunotherapy, particularly with agents like tislelizumab (an anti-PD-1 monoclonal antibody), works by blocking the PD-1 pathway, which cancer cells exploit to evade the immune system. By inhibiting this pathway, tislelizumab reactivates T-cells, allowing them to recognize and attack cancer cells. This mechanism is crucial for gastric cancer patients as it offers a novel approach to treatment, potentially improving survival rates and providing options for those who may not respond to traditional therapies.

What side effects are associated with this type of intervention?

Common treatments for gastric cancer, such as PD-1 inhibitors (e.g., Tislelizumab, Pembrolizumab) and chemotherapy, have a range of side effects. PD-1 inhibitors can cause immune-related adverse events including skin reactions, endocrine disorders, and pneumonitis. Chemotherapy often leads to gastrointestinal issues like nausea, vomiting, and diarrhea, as well as hematologic toxicities such as neutropenia and anemia. Combining these treatments can increase the incidence of severe adverse events, necessitating careful management and monitoring.

What prior FDA approvals exist?

Pembrolizumab, an anti-PD-1 monoclonal antibody, has been approved by the FDA for the treatment of PD-L1-positive advanced gastric or gastroesophageal junction adenocarcinoma. This approval is based on clinical trials demonstrating its efficacy in improving overall survival and progression-free survival compared to chemotherapy. Other PD-1 inhibitors like Avelumab have been studied, but did not show significant benefits in certain trials. These treatments are part of a broader category of immune checkpoint inhibitors that target the PD-1/PD-L1 pathway to enhance the body's immune response against cancer cells.

What other types of research exist?

Promising alternatives to Tislelizumab for gastric cancer patients include: 1) Ramucirumab in combination with FLOT chemotherapy, as studied in the RAMSES/FLOT7 trial. 2) Atezolizumab in combination with FLOT chemotherapy, as investigated in the DANTE trial. 3) Durvalumab combined with FLOT chemotherapy, as assessed in ongoing clinical trials. These alternatives have shown potential in improving outcomes for gastric cancer patients.

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Anti-metabolites

Tislelizumab + Chemotherapy for Gastric Cancer

Phase 3

Waitlist Available

Research Sponsored by BeiGene

Eligibility Criteria Checklist

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

Must have

Locally advanced unresectable or metastatic GC or GEJ carcinoma with histologically confirmed adenocarcinoma

Be older than 18 years old

Must not have

Diagnosed with gastric or GEJ adenocarcinoma with positive HER2

Active leptomeningeal disease or uncontrolled brain metastasis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 months

Awards & highlights

Pivotal Trial

Approved for 5 Other Conditions

Summary

This trial is testing a new treatment that combines an immune-boosting drug called tislelizumab with standard chemotherapy. It targets patients with advanced stomach cancer that cannot be removed by surgery and has spread to other parts of the body. The treatment works by helping the immune system find and destroy cancer cells.

Who is the study for?

Adults with inoperable, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma can join this trial. They shouldn't have had systemic therapy for their condition yet but may have completed prior therapies without recurrence for at least 6 months. Participants need to be relatively fit (ECOG PS ≤ 1) and have good organ function.

What is being tested?

The study is testing Tislelizumab combined with chemotherapy against a placebo plus chemotherapy as the first-line treatment. It's a phase 3 trial where participants are randomly assigned to either group in equal numbers, and neither they nor the researchers know who gets which treatment (double-blind).

What are the potential side effects?

Tislelizumab could cause immune-related reactions, fatigue, nausea, liver issues, skin rash and increase infection risk. Chemotherapy agents like Cisplatin and Capecitabine might lead to digestive problems, nerve damage, low blood cell counts causing bruising or infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is in the stomach or esophagus and cannot be surgically removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have stomach or junction cancer that is HER2 positive.

Select...

I have active cancer spread to the brain or its linings that is not under control.

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I have previously been treated with drugs targeting immune checkpoints.

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My stomach cancer is of a specific type (squamous cell, undifferentiated).

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS)

Secondary study objectives

Disease control rate (DCR)

Duration of response (DOR)

Overall response rate (ORR)

+3 more

Side effects data

From 2022 Phase 3 trial • 512 Patients • NCT03430843

31%

Anaemia

24%

Weight decreased

17%

Cough

16%

Decreased appetite

16%

Pyrexia

16%

Constipation

15%

Nausea

15%

Aspartate aminotransferase increased

14%

Hypoalbuminaemia

13%

Alanine aminotransferase increased

13%

Diarrhoea

13%

Fatigue

12%

Hyponatraemia

12%

Hypothyroidism

11%

Asthenia

11%

Vomiting

11%

Back pain

11%

Pneumonia

10%

Dyspnoea

10%

Pruritus

Dysphagia

Arthralgia

Hypokalaemia

Rash

Insomnia

Hyperglycaemia

Blood alkaline phosphatase increased

Productive cough

Abdominal pain

Malaise

Lymphocyte count decreased

Gastrooesophageal reflux disease

White blood cell count increased

Platelet count decreased

Gamma-glutamyltransferase increased

Hypoproteinaemia

Hypertension

Pneumonitis

Stomatitis

Blood bilirubin increased

Hypotension

Oedema peripheral

Abdominal pain upper

Abdominal distension

Nasopharyngitis

White blood cell count decreased

Haemoptysis

Cancer pain

Dizziness

Leukopenia

Blood creatine phosphokinase MB increased

Blood creatine phosphokinase increased

Upper respiratory tract infection

Myalgia

Hypoglycaemia

Hyperthyroidism

Hypocalcaemia

Dysphonia

Hyperkalaemia

C-reactive protein increased

Upper gastrointestinal haemorrhage

Hypochloraemia

Hyperuricaemia

Thrombocytopenia

Oesophageal obstruction

Neutrophil count decreased

Pneumonia aspiration

Tumour pain

Hypercalcaemia

Immune-mediated myositis

Neutropenia

Death

Oesophageal fistula

Multiple organ dysfunction syndrome

Peripheral sensory neuropathy

Oesophagomediastinal fistula

Pulmonary haemorrhage

Oesophageal stenosis

Pleural effusion

General physical health deterioration

Pulmonary embolism

Immune-mediated lung disease

Sepsis

Type 1 diabetes mellitus

100%

80%

60%

40%

20%

Study treatment Arm

Tislelizumab

Investigator Chosen Chemotherapy (ICC)

Awards & Highlights

Pivotal Trial

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

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

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

2014

Completed Phase 3

~3100

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for gastric cancer include chemotherapy, targeted therapy, and immunotherapy. Immunotherapy, particularly with agents like tislelizumab (an anti-PD-1 monoclonal antibody), works by blocking the PD-1 pathway, which cancer cells exploit to evade the immune system. By inhibiting this pathway, tislelizumab reactivates T-cells, allowing them to recognize and attack cancer cells. This mechanism is crucial for gastric cancer patients as it offers a novel approach to treatment, potentially improving survival rates and providing options for those who may not respond to traditional therapies.