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Anti-metabolites

Immunotherapy + Chemoradiation for Gastric Cancer

Q: In what scenarios is Nivolumab a beneficial treatment option?

<p>Nivolumab can be used to tackle unresectable <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, <a href="https://www.withpower.com/clinical-trials/squamous-cell-carcinoma">squamous cell carcinoma</a>, as well as rectal carcinomas.</p>

Phase 2

Waitlist Available

Led By Mariela Blum

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Subject must be previously untreated with systemic treatment (including HER 2 inhibitors) given as primary therapy for advanced or metastatic disease. No prior neoadjuvant chemotherapy, immunotherapy, radiotherapy and/or chemoradiotherapy are permitted.

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing a combination of immunotherapy drugs, chemo, and radiation to treat gastric cancer. The hope is that the immunotherapy will help the body's immune system attack the cancer, and that the combination of treatments will be more effective than any one treatment alone.

Who is the study for?

This trial is for patients with resectable gastric or gastroesophageal junction adenocarcinoma, without prior systemic treatment for advanced disease. Participants must have adequate organ function and performance status, not be pregnant or breastfeeding, and agree to contraception if applicable. Exclusions include previous immunotherapy, certain allergies, active autoimmune diseases requiring steroids, other cancers within 3 years (with exceptions), HIV/AIDS positive status, and serious uncontrolled medical disorders.Check my eligibility

What is being tested?

The study tests the combination of nivolumab and ipilimumab (immunotherapies) with chemotherapy drugs oxaliplatin and fluorouracil plus intensity-modulated radiation therapy in treating resectable gastric cancer. The goal is to see how well this combo works by helping the immune system attack cancer while minimizing damage to healthy tissue.See study design

What are the potential side effects?

Potential side effects may include typical reactions from immunotherapy such as fatigue, skin reactions, digestive issues; chemotherapy-related nausea, hair loss; radiation-induced skin changes; increased risk of infections due to a weakened immune system; liver enzyme elevation; blood cell count changes.

Eligibility Criteria

Inclusion Criteria

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

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I have not received any systemic treatment for my advanced or metastatic disease.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am not pregnant, have tested negative for pregnancy, and am not breastfeeding.

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I have a type of stomach or junction cancer that can be operated on and has not spread to my abdomen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of adverse events

Secondary outcome measures

Disease-free survival

Incidence of adverse events in patients with resected gastroesophageal junction (GEJ) or gastric cancer

Response rates

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (chemotherapy, immunotherapy, IMRT)Experimental Treatment6 Interventions

INDUCTION CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours and fluorouracil IV over 48 hours on day 1. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1. Treatment with nivolumab repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning course 4, patients also receive fluorouracil IV continuously for 5 days per week and undergo 25 fractions of IMRT for 5 weeks. Patients undergo surgical resection 5-7 weeks after completing radiation therapy. Within 8-12 weeks post-surgery, patients with residual disease may receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for 8 courses (16 weeks) then every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9850

Intensity-Modulated Radiation Therapy

2010

Completed Phase 3

~2160

Ipilimumab

2014

Completed Phase 3

~2620

Nivolumab

2014

Completed Phase 3

~4750

Oxaliplatin

2011

Completed Phase 4

~2560

Fluorouracil

2014

Completed Phase 3

~11540

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,971 Previous Clinical Trials

1,787,205 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,609 Total Patients Enrolled

Mariela BlumPrincipal InvestigatorM.D. Anderson Cancer Center

2 Previous Clinical Trials

55 Total Patients Enrolled

Media Library

Fluorouracil (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03776487 — Phase 2

Stomach Cancer Research Study Groups: Treatment (chemotherapy, immunotherapy, IMRT)

Stomach Cancer Clinical Trial 2023: Fluorouracil Highlights & Side Effects. Trial Name: NCT03776487 — Phase 2

Fluorouracil (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03776487 — Phase 2

Frequently Asked Questions

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

In what scenarios is Nivolumab a beneficial treatment option?

"Nivolumab can be used to tackle unresectable melanoma, squamous cell carcinoma, as well as rectal carcinomas."

Answered by AI

How many participants can the research team accommodate in this trial?

"Affirmative. The information on clinicaltrials.gov attests that this medical trial is seeking participants, initially posted on January 7th 2019 and lastly updated July 5th 2022. This research project requires recruiting 30 patients from one site."

Answered by AI

Is this trial currently recruiting participants?

"According to clinicaltrials.gov, this study is actively seeking participants and has been since its posting on the 7th of January 2019. The trial was most recently edited on the 5th of July 2022."

Answered by AI

Are there any previous studies that have employed Nivolumab as a treatment?

"Currently, 1228 clinical studies are being conducted to evaluate the effectiveness of Nivolumab. Of these trials, 249 have reached Phase 3 and 62693 locations around Guangzhou in Guangdong province are running assessments for this medication."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nivolumab, Ipilimumab and Chemoradiation in Treating Patients With Resectable Gastric Cancer

2019. "Nivolumab, Ipilimumab and Chemoradiation in Treating Patients With Resectable Gastric Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03776487.

All > Esophagus Cancer > Gastric Cancer