Can immunotherapy alone eliminate stomach tumors and spare patients surgery?

NCT ID NCT04817826

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing whether a combination of two immunotherapy drugs, tremelimumab and durvalumab, can treat MSI-high gastric or gastroesophageal junction cancer without immediate surgery. The trial enrolls adults with resectable tumors and gives the drugs before a planned operation, or as the main treatment for those who may not need surgery. The goal is to see how many patients achieve a complete response, meaning no detectable cancer cells, and to track quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a combination of two immunotherapy drugs, tremelimumab and durvalumab
What this could lead to
If it works, this could offer some people with MSI-high stomach or gastroesophageal junction cancer a way to avoid surgery and its long-term effects.
What could go wrong
This is a small phase 2 trial with 31 participants, so results may not hold in larger studies. Immunotherapy can cause serious immune-related side effects, and not everyone's cancer will respond.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 31 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2021

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Written informed consent and any locally required authorization (such as the European Union \[EU\] Data Privacy Directive) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations. 2. Age ≥ 18 years old. 3. ECOG Performance Status 0-1. 4. Body weight \>30 kg. 5. Diagnosis of resectable gastric or gastroesophageal junction (Siewert II-III) cancer, categorized according to TNM classification 8th edition: * cT ≥ 2, any cN, M0 * Any cT, cN1-3, M0 6. Absence of distant metastases as defined by negativity of computed tomography (CT) and 18-fluorodeoxyglucose positron-emission tomography (18-FDG PET). 7. Life expectancy of at least 12 weeks 8. MSI-high status confirmed by IHC and multiplex PCR, and EBV-negative status by ISH, as determined centrally at the Co-ordinating Centre. Lack of heterogeneity of dMMR status as showed by lack of tumor cells showing concomitant expression of all 4 protein markers. 9. Adequate bone marrow and organ function, as defined by laboratory tests: 1. Neutrophil count ≥ 1.5 x 10\^3/μL 2. Platelet count ≥ 100 x 10\^6/μL 3. Haemoglobin ≥ 9 g/dL 4. Total bilirubin lower than 1.5 time the upper-normal limits (ULN) of the Institutional normal values 5. AST (SGOT) and/or ALT (SGPT) \< 2.5 x ULN 6. Creatinine clearance (calculated according to Cockroft and Gault) \> 40 mL/min or serum creatinine \< 1.5 x ULN. 10. Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating Centre. Exclusion Criteria: 1. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site) 2. Previous enrolment in the present study 3. Participation in another clinical study with an investigational product during the last 12 months 4. Signs of distant metastases. 5. Prior medical treatments or irradiation for gastric cancer. 6. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable. 7. Previous treatments with immune checkpoint inhibitors targeting CTLA4, including tremelimumab, PD-1 or PD-L1, including durvalumab. 8. History of allergy or severe hypersensitivity reaction to monoclonal antibodies. 9. History of autoimmune diseases or history of organ transplantation that require immunosuppressive therapy. The following are exceptions to this criterion: * Patients with vitiligo or alopecia * Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement * Any chronic skin condition that does not require systemic therapy * Patients with celiac disease controlled by diet alone 10. History of active primary immunodeficiency. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA 11. Any condition requiring systemic treatment with corticosteroids at doses equal or superior to 10 mg daily of prednisone or equivalents, or other immunosuppressive drugs within 14 days from the inclusion in the study. The following medications are exceptions to this criterion: * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection) * Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) 12. Administration of live vaccines within 4 weeks from the inclusion in the study. Note: Patients, if enrolled, should not receive live vaccine while receiving study drug(s) and up to 30 days after the last dose of study drug(s). 13. History of allogenic organ transplantation 14. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent 15. Women in pregnancy or lactation condition. Women with child-bearing potential or sexually-active men not willing to use adequate contraception during the whole study period. 16. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.

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Conditions

The condition(s) this trial relates to.

gastric cancer gastric neoplasm Microsatellite Instability

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

    Milan, 20133, Italy

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