What side effects are associated with this type of intervention?

Common treatments for stomach cancer, such as chemotherapy, immune checkpoint inhibitors (like pembrolizumab and nivolumab), and targeted therapies, often come with a range of side effects. Chemotherapy can cause nausea, vomiting, fatigue, hair loss, and increased risk of infection. Immune checkpoint inhibitors may lead to immune-related adverse events, including colitis, pneumonitis, hepatitis, and endocrinopathies. Targeted therapies, such as VEGFR inhibitors, can result in hypertension, hand-foot syndrome, and gastrointestinal perforations. These side effects vary in severity and frequency, and patients should discuss them with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

FDA-approved treatments for stomach cancer that target multiple pathways include trastuzumab, a monoclonal antibody targeting HER2, used in combination with chemotherapy for HER2-positive gastric cancer. Ramucirumab, an anti-VEGFR2 antibody, is approved for use alone or with paclitaxel in advanced gastric cancer. Pembrolizumab, an anti-PD-1 therapy, is approved for PD-L1 positive gastric cancer. These treatments reflect a trend towards targeting specific molecular pathways involved in cancer progression, similar to the investigational combinations in the 'Novel Combination Therapies' trial.

What other types of research exist?

Promising novel alternatives for stomach cancer treatment in 2024 include: <ol> <li>Apatinib (Rivoceranib) - An orally active VEGFR-2 inhibitor, shown to modestly prolong overall survival in advanced gastric cancer patients in a multicenter trial.</li> <li></li> </ol> Regorafenib - An orally active inhibitor of angiogenic pathways, including VEGFR-1 to VEGFR-3, with potential activity in advanced gastric cancer. 3. Pembrolizumab - An immunotherapy agent that has shown efficacy across multiple cancers, including gastric cancer, particularly in patients with specific genetic profiles. 4. Nivolumab - Another immunotherapy option, which can be used as monotherapy or in combination with other agents for advanced gastric cancer.

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Other

Novel Treatments for Stomach Cancer

Phase 2

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through substudy completion, an average of 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing new combinations of drugs to treat advanced stomach cancer that can't be removed by surgery or has spread. Researchers want to see if these drug combinations are effective and safe, and how the body handles them. A group of patients will participate to find the best dose.

Who is the study for?

Adults over 18 with a body weight above 35 kg, diagnosed with advanced gastric or gastroesophageal junction adenocarcinoma that can't be surgically removed or has spread, and who haven't been treated for it yet. Participants should have a life expectancy of at least 12 weeks and good performance status (able to carry out daily activities). Those with active infections, previous immune-oncology treatments, certain HER2-positive cancers, uncontrolled brain metastases, serious illnesses, another cancer history or uncontrollable ascites are excluded.

What is being tested?

The trial is testing new combinations of drugs including chemotherapy agents like 5-Fluorouracil and Capecitabine as well as novel therapies AZD0901, Rilvegostomig, FOLFOX regimen components and Volrustomig. It aims to evaluate how effective these combinations are in treating the cancer while also monitoring safety profiles and how the body processes the drugs.

What are the potential side effects?

Potential side effects may include nausea and vomiting from chemotherapy; fatigue; allergic reactions; blood cell count changes leading to increased infection risk or bleeding problems; liver function alterations; diarrhea or constipation; mouth sores. Novel drug side effects vary but could involve similar issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through substudy completion, an average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through substudy completion, an average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through substudy completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

ORR (per RECIST 1.1 as assessed by Investigator)

PFS6 (per RECIST 1.1 as assessed by Investigator)

Secondary study objectives

DoR per RECIST 1.1 based on Investigator assessment.

PFS per RECIST 1.1 as assessed by the Investigator

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Substudy 6Experimental Treatment4 Interventions

AZD0901 plus AZD7789 and 5-fluorouracil or capecitabine

Group II: Substudy 5Experimental Treatment3 Interventions

AZD7789 plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)

Group III: Substudy 4Experimental Treatment4 Interventions

AZD0901 plus rilvegostomig and 5-fluorouracil or capecitabine

Group IV: Substudy 3Experimental Treatment4 Interventions

AZD0901 plus volrustomig and 5-fluorouracil or capecitabine

Group V: Substudy 2Experimental Treatment3 Interventions

Rilvegostomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)

Group VI: Substudy 1Experimental Treatment3 Interventions

Volrustomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

FOLFOX

2009

Completed Phase 3

~4560

XELOX

2018

Completed Phase 3

~620

5-Fluorouracil

2012

Completed Phase 3

~7800

Capecitabine

2013

Completed Phase 3

~4280

Do I qualify?Apply below to find out

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 stomach cancer include targeted therapies, chemotherapy, and immunotherapy. Targeted therapies, such as VEGFR inhibitors, work by blocking specific molecules involved in tumor growth and angiogenesis, thereby starving the tumor of nutrients and slowing its progression. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells, but it also affects normal cells, leading to side effects. Immunotherapy, including checkpoint inhibitors like pembrolizumab, enhances the body's immune response against cancer cells. These treatments are crucial for stomach cancer patients as they offer multiple avenues to attack the cancer, potentially improving outcomes and providing options when the cancer becomes resistant to one form of treatment.

Does tumor profile in gastric and gastroesophageal (GE) junction cancer justify off-label use of targeted therapy?-a narrative review.Compound-therapy based on cancer-immunity cycle: promising prospects for antitumor regimens.Novel perspectives for the treatment of gastric cancer: from a global approach to a personalized strategy.