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New drug combos aim to boost survival in Hard-to-Treat cancers

NCT ID NCT03281369

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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Aug 04, 2026 · Updated 3 times

Summary

This study tested several immunotherapy-based drug combinations in 214 people with advanced stomach, gastroesophageal junction, or esophageal cancer that could not be removed by surgery or had spread. Participants received either standard chemotherapy or chemotherapy plus the immunotherapy atezolizumab (Tecentriq) and other drugs. The goal was to see if these combinations were safe and worked better than standard treatment alone.

What this could mean

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

Active substance
Atezolizumab (Tecentriq) plus chemotherapy (5-FU, leucovorin, oxaliplatin) and other immunotherapy drugs
What this could lead to
If successful, this could point toward more effective treatment combinations for advanced gastric and esophageal cancers, potentially improving survival and response rates.
What could go wrong
This is an early-phase (1b/2) umbrella study with multiple arms, so results are preliminary. The combinations may not prove better than standard chemotherapy and could have added side effects.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

219 people

The number who actually took part.

Started

Oct 2017

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: Gastric Cancer Cohorts Inclusion Criteria: * Age \>/= 18 years; * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; * Life expectancy \>/= 3 months, as determined by the investigator; * Histologically or cytologically confirmed locally advanced unresectable or metastatic adenocarcinoma of gastric or gastroesophageal junction; (for the 1L Gastric Cancer Cohort: no prior systemic therapy for the locally advanced or metastatic disease; for the 2L Gastric Cancer Cohort: disease progression during or following a first-line platinum-containing or fluoropyrimidine-containing chemotherapy regimen); * Availability of a representative tumor specimen that is suitable for determination of PD-L1 and TIGIT levels by IHC and/or additional biomarker status by means of retrospective central testing; * Only for the 1L Gastric Cancer Cohort: human epidermal growth factor receptor 2 (HER2)-negative tumors; * Measurable disease (at least one target lesion) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1); * Adequate hematologic and end organ function based on laboratory results obtained within 14 days prior to initiation of study treatment; * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures as outlined for each specific treatment arm; * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm. Esophageal Cancer Cohort Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of squamous cell carcinoma or adenocarcinoma of the esophagus in locally advanced or metastatic disease; * No prior systemic treatment for esophageal cancer, with the following exception: For patients treated with chemotherapy in the locally advanced setting: occurrence of metastasis after 6 months from the last dose of chemotherapy; * For patients with adenocarcinoma: absence of HER2 expression; * Life expectancy \>/=3 months as determined by the investigator; * Measurable disease per RECIST v1.1; * Adequate hematologic and end-organ function; * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs; * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm; * ECOG Performance Status of 0, 1, or 2. Exclusion Criteria: Exclusion criteria for the 2L Gastric Cancer Cohort: * Urinary protein is \> 1 + on dipstick and the required following 24-hour urine collection shows urinary protein \> 2000 mg; * Serious or non-healing wound, peptic ulcer, or bone fracture within 28 days prior to initiation of study treatment; * History of gastrointestinal perforation and/or fistulae within 6 months prior to initiation of study treatment; * Presence of a bowel obstruction, history or presence of inflammatory enteropathy, or extensive intestinal resection, Crohn disease, ulcerative colitis, or chronic diarrhea; * Uncontrolled arterial hypertension \>/= 150/ \>/= 90 millimeter of mercury (mmHg) despite standard medical management; * Chronic therapy with non-steroidal anti-inflammatory agents or other anti-platelet agents. Gastric Cancer Exclusion Criteria: * Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy; * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases; * History of leptomeningeal disease; * Active or history of autoimmune disease or immune deficiency; * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan; * Positive test for human immunodeficiency virus (HIV) at screening; * Active hepatitis B virus (HBV) or hepatitis C (HCV) infection; * Severe infection within 4 weeks prior to initiation of study treatment; * Significant cardiovascular disease; * Significant bleeding disorder; * Prior allogeneic stem cell or solid organ transplantation; * Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study; * Treatment with anticoagulation with warfarin, low-molecular-weight heparin, or similar agents for therapeutic purposes; * History of malignancy other than gastric or gastroesophageal junction carcinoma within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death; * Known allergy or hypersensitivity to any of the study drugs or their excipients. Esophageal Cancer Cohort Exclusion Criteria: * High risk for developing esophageal fistula by clinical assessment or imaging; * Symptomatic, untreated, or actively progressing central nervous system (CNS) Metastases; * Positive EBV viral capsid antigen IgM test at screening; * History of leptomeningeal disease; * Active or history of autoimmune disease or immune deficiency; * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan; * Active tuberculosis; * Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina; * History of malignancy other than esophageal cancer within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death; * Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab or within 90 days after the final dose of tiragolumab.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Barts and The London School of Medicine and Dentistry - Barts Cancer Institute (BCI)-CECM

    London, 0, United Kingdom

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN, United Kingdom

  • Blacktown Hospital

    Blacktown, New South Wales, 2148, Australia

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Hospital Universitari Vall dHebron

    Barcelona, 08035, Spain

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

  • Mayo Clinic Cancer Center

    Scottsdale, Arizona, 85259, United States

  • Monash Medical Centre-Moorabbin Campus

    Clayton, Victoria, 3168, Australia

  • National Cheng Kung University Hospital

    Tainan, 70457, Taiwan

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Rambam Health Care Campus

    Haifa, 3109601, Israel

  • Samsung Medical Center

    Seoul, 135-710, South Korea

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 110-744, South Korea

  • Sourasky Medical Centre

    Tel Aviv, 64239, Israel

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tennessee Oncology - Nashville

    Nashville, Tennessee, 37203, United States

  • The Catholic University of Korea St. Vincent's Hospital

    Suwon, 442-723, South Korea

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • The Royal Marsden

    London, SW7 3RP, United Kingdom

  • The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH) - Sutton

    Sutton, SM2 5PT, United Kingdom

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030-4000, United States

  • UCLA Jonsson Comprehensive Cancer Center

    Santa Monica, California, 90404, United States

  • Uni of Southern California

    Los Angeles, California, 90033, United States

  • Universidad de Navarra - Clinica Universitaria de Navarra (CUN)

    Pamplona, Navarre, 31008, Spain

  • University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC)

    Songpa-gu, 05505, South Korea

  • Yonsei University College of Medicine (YUCM)-Yonsei Cancer Center

    Seoul, South Korea

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