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Chemotherapy + Immunotherapy for Stomach Cancer

Phase 2

Waitlist Available

Led By Weijing Sun, MD, FACP

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

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

Must have

Male/female participants who are 18 - 75 years of age with histologically or cytologically confirmed diagnosis of adenocarcinoma of the gastroesophegeal junction (GEJ) or stomach

Have newly diagnosed localized or locally advanced, potentially resectable disease without any prior systemic chemotherapy

Must not have

Received prior therapy with anti-PD-1, anti-PD-L1, or anti PD L2 agents or with agents directed to another stimulatory or co-inhibitory T-cell receptor

Has biopsy-proven invasion of tracheobronchial tree or tracheo-esophageal fistula

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 14 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of two drugs to see if they are effective and safe in treating stomach cancer.

Who is the study for?

This trial is for adults aged 18-75 with newly diagnosed, potentially operable stomach or gastroesophageal junction cancer without distant spread. Participants must be fit for surgery, have no recent other cancers or major illnesses, and not be pregnant or breastfeeding. They should agree to use contraception and provide tissue samples.

What is being tested?

The study tests the combination of mFOLFOX6 chemotherapy with Pembrolizumab (an immunotherapy drug) before and after surgery in patients with stomach or GEJ cancer. The goal is to assess how well this combo works against the tumor and its safety.

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs, infusion-related symptoms, fatigue, digestive issues like nausea and diarrhea, blood cell count changes increasing infection risk, skin reactions, and potential nerve damage.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 75 years old with a confirmed diagnosis of stomach or GEJ cancer.

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My cancer is new, localized or locally advanced, and I haven't had chemotherapy.

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I am a woman who can have children and have a negative pregnancy test.

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I have a tumor that can be measured and tissue from before surgery is available.

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I am willing to undergo a biopsy for my cancer study.

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

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My cancer has not spread to distant parts of my body.

Exclusion Criteria

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

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I have been treated with specific immune therapy drugs before.

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My cancer has spread to my windpipe area or caused a hole between my windpipe and esophagus.

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I have an active tuberculosis infection.

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I have another cancer that is getting worse or was treated in the last 3 years.

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I have had pneumonitis treated with steroids or currently have it.

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I am currently being treated for an infection.

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I have a history of HIV, Hepatitis B, or active Hepatitis C.

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I cannot have surgery due to other health issues.

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I don't have any health conditions that would stop me from taking the study drugs.

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I have an autoimmune disease that needed treatment in the last 3 months.

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My cancer has spread to distant parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 14 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 14 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 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

Number of Adverse Events related to toxicity.

Pathological response rate (ypRR)

Secondary study objectives

Disease Free Survivial (DFS)

Objective response rate (ORR)

Overall Survival (OS)

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: mFOLFOX6 (Leucovorin-Fluorouracil-Oxaliplatin) + PembrolizumabExperimental Treatment2 Interventions

Drug: Pembrolizumab Dose: 200 mg Dose Frequency: Every three weeks (Q3W) Route: Intravenous (IV) infusion Drug: Oxaliplatin Dose: 85 milligrams per meter squared (mg/m2) Dose Frequency: Every 2 weeks (Q2W) Route: IV infusion Drug: Leucovorin Dose: 400 mg/m2 Dose Frequency: Q2W Route: IV infusion Drug: Fluorouracil Dose: 400 mg/m2 Dose Frequency: Q2W Route: IV bolus Drug: Fluorouracil Dose: 2,400 mg/m2 Dose Frequency: Q2W Route: IV continuous 46-hour infusion Pembrolizumab will be administered at a fixed dose of 200 mg IV over 30 minutes every 3 weeks. Participants will receive 3 doses of the drug on Days 1, 22, 43 during the neoadjuvant phase of the study, and 12 doses of the drug on Days 1, 22, 43 during the adjuvant phase of the study (total 15 doses). Participants will receive 4 doses of mFOLFOX6 regimen on Days 1, 15, 29, 43 during the neoadjuvant phase of the study, and 4 doses during the adjuvant phase of the study (total 8 doses).

0 / 18Eligibility criteria met