New drug combos aim to boost survival in Hard-to-Treat cancers
NCT ID NCT03281369
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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219 people
The number who actually took part.
- Started
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Oct 2017
- Finished
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Oct 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Barts and The London School of Medicine and Dentistry - Barts Cancer Institute (BCI)-CECM
London, 0, United Kingdom
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Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
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Blacktown Hospital
Blacktown, New South Wales, 2148, Australia
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Columbia University Medical Center
New York, New York, 10032, United States
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Hospital Universitari Vall dHebron
Barcelona, 08035, Spain
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Korea University Anam Hospital
Seoul, 02841, South Korea
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Mayo Clinic Cancer Center
Scottsdale, Arizona, 85259, United States
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Monash Medical Centre-Moorabbin Campus
Clayton, Victoria, 3168, Australia
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National Cheng Kung University Hospital
Tainan, 70457, Taiwan
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National Taiwan University Hospital
Taipei, 100, Taiwan
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Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
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Rambam Health Care Campus
Haifa, 3109601, Israel
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Samsung Medical Center
Seoul, 135-710, South Korea
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Seoul National University Bundang Hospital
Gyeonggi-do, 13620, South Korea
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Seoul National University Hospital
Seoul, 110-744, South Korea
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Sourasky Medical Centre
Tel Aviv, 64239, Israel
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Taipei Veterans General Hospital
Taipei, 11217, Taiwan
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Tennessee Oncology - Nashville
Nashville, Tennessee, 37203, United States
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The Catholic University of Korea St. Vincent's Hospital
Suwon, 442-723, South Korea
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The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
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The Royal Marsden
London, SW7 3RP, United Kingdom
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The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH) - Sutton
Sutton, SM2 5PT, United Kingdom
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The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4000, United States
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UCLA Jonsson Comprehensive Cancer Center
Santa Monica, California, 90404, United States
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Uni of Southern California
Los Angeles, California, 90033, United States
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Universidad de Navarra - Clinica Universitaria de Navarra (CUN)
Pamplona, Navarre, 31008, Spain
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University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC)
Songpa-gu, 05505, South Korea
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Yonsei University College of Medicine (YUCM)-Yonsei Cancer Center
Seoul, South Korea
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